DEmo

Pilot Interventional Study Comparing Fetomaternal Outcomes 27

Table 3 Maternal high-risk factors in women who developed PE 75 mg aspirin n = 87 Overall
p Unadjusted OR (95% CI)
150 mg aspirin n = 91

Hypothyroidism 8 (8.7%) 7 (8%) 0.858 0.908 (0.315–2.620)
APLA 1 (1%) 3(3.4%) 0.316 3.214 (0.328–31.508)
Autoimmune diseases 1 (1%) 1 (1.1%) 0.974 1.047 (0.064–16.996
GDM 5 (5.4%) 7 (8%) 0.500 1.505 (0.459–4.934)
Type 2 diabetes 1 (1%) 3 (3.4%) 0.316 3.214 (0.328–31.508)
Chronic hypertension 2(2.1%) 5(5.7%) 0.617 1.589 (0.259–9.749)
Mean arterial pressure 102.5 ± 5.24 99.87 ± 8.36 0.138
Uterine artery PI 2.84 ± 0.32 85.11 ± 7.52 <0.001 2.66 ± 0.48 86.9 ± 7.51 < 0.001 0.166
History of early-onset 2 (2.19%) 2.23 ± 0.47 0.002 0.143 (CI 0.003–5.951) 2.31 ± 0.50 0.015
3 (3.4%) 0.819
preeclampsia in previous 5 (5.5%)
pregnancy 4 (4.6%) 0.764 0.667 (CI 0.047–9.47864)
History of late-onset PE in
previous pregnancy

Table 4 Comparison of foetal outcome in both the groups on the risk of preeclampsia, severe preeclampsia and foetal
growth restriction. The entire focus is now shifted on early
150 mg aspirin 75 mg aspirin p identification of women at risk of preeclampsia and starting
n = 91 n = 87 low-dose aspirin preferably before 16 weeks.

Preeclampsia 1 (1%) 3 (3.4%) 0.359 Evidence also suggests that preterm PE can be predicted
 Still birth 1(1%) 2 (2.3%) 0.264 in early pregnancy and prevented with a minimum dose
 Neonatal death 2 (2.1%) 6 (6.9%) 0.249 of aspirin initiated also in early pregnancy [15, 18]. The
 NICU admission 2 (2.1%) 8 (9.2%) 0.088 ASPRE trial [19] which compared 150 mg aspirin with pla-
 Foetal growth restriction 2.38 ± 0.44 2.03 ± 0.58 0.148 cebo has also shown a potential benefit of 150 mg aspirin in
 Baby weight at birth prevention of preeclampsia, but they suggested that preven-
No preeclampsia 0 1 (1.1%) 0.488 tion is restricted to preterm preeclampsia, while we realized
 Still birth 7 (7.7%) 6 (6.9%) 0.838 that in our population, there is reduction of late preeclampsia
 Foetal growth restriction 2.91 ± 0.57 2.83 ± 0.55 0.374 as well.
 Baby weight at birth 6 (6.6%) 7 (8%) 0.932
 NICU admission 1 (1%) 2 (2.3%) 0.264 The incidence of women found to be at high risk of preec-
 Neonatal mortality 9 (9.9%) 14 (16%) 0.312 lampsia in our setting was 18%, and 10.5% of them devel-
 Total FGR oped PE. The incidence of PE is high and implies that the
pregnant women in this part of the world are more prone to
Bujold [10] did a meta-analysis of 34 RCTs in which develop preeclampsia. The incidence of preeclampsia has
they compared low-dose aspirin given at ≤ 16 weeks ver- been reported differently in different studies; it is certainly
sus placebo and found a higher incidence of preeclampsia affected by the demography of the population studied. Stud-
(9.3 vs. 21.3%), severe PE (0.7 vs. 15%), FGR (7 vs. 16%), ies have reported incidence to vary from 1% [20], 21% [11]
gestational HTN (16.7 vs. 29.7%) and preterm birth (3.5 to as high as 62% [21].
vs. 16.9%) in the control group. However, studies done
later questioned the efficacy of 75 mg aspirin compared to In the group of women who were given 150 mg aspi-
a higher dose. Stephanie Roberge [17] did a meta-analysis rin, preeclampsia occurred in 6.5% versus 17.2% in women
of 45 randomized controlled trials, comparing the effect of given 75 mg aspirin. There was significant group difference
daily aspirin in various doses or placebo during pregnancy, between the development of severe PE (10.3 vs. 2.1%) and
and reported that prevention of preeclampsia and foetal mean period of gestation at the time of delivery (p = 0.007)
growth restriction using aspirin in early pregnancy is asso- as shown in table 2. Both the groups required one or two
ciated with a dose–response effect (50–150 mg) with higher antihypertensives (labetalol 600–800 mg and nifedipine
dosage having a better effect on prevention of preeclampsia 10–20 mg) for treatment of hypertension. Magnesium sul-
(p < .001), severe preeclampsia (p = .008) and foetal growth phate prophylaxis was given to all women who developed
restriction (p < .001), while low-dose aspirin initiated at severe PE. Difference in occurrence of placental abruption
more than 16 weeks’ gestation has a modest or no impact was not statistically significant in both the groups, and none
of the women turned into eclampsia in both the groups.

In a study done by Plasencia et al. [2], they reported that
uterine artery screening PI at 11 + 0 to 13 + 6 weeks and

13

28 Kumar et al.

the change in uterine artery PI between 11 + 0 to 13 + 6 dose of the drug. In the light of the trial finding, the benefit
and 21 + 0 to 24 + 6 weeks of gestation provided significant applicable in Indian scenario is a consistent use of 150 mg
independent contribution to the prediction of preeclampsia aspirin, a tested dose which is effectively preventing PE
with the detection rates of early- and late-onset preeclampsia without any identifiable harm.
being 90.9 and 31.0%. In our study, we found a higher level
of uterine artery PI in women who developed PE. Almost all Conclusion
women had PI value of more than 2.5 irrespective of exact
period of gestation between 11 and 14 weeks. The incidence of both preeclampsia and eclampsia is high
in a developing country like India. We encounter maternal
Mean arterial pressure of women who develop preec- deaths due to hypertensive disorders; hence, potential benefit
lampsia was higher than those who did not. In a study by by early screening and intervention is clear and laudable.
Poon [22], they evaluated the performance of screening for This randomized trial showed that among women with sin-
preeclampsia (PE) by maternal medical history and mean gleton pregnancies who were identified by means of first-
arterial pressure (MAP) at 11 weeks to 13 weeks 6 days. trimester screening as being at high risk of preterm preec-
The detection rate of PE by log multiple of the median MAP lampsia, use of aspirin 150 mg per day started between 11
and maternal variables was 62.5% for a false-positive rate and 14 weeks till 36 weeks is a potent intervention to reduce
of 10%. The mean arterial pressure was affected by ethnic the development of both early- and late-onset preeclampsia
origin, body mass index and personal history of PE. Litera- as compared to a dose of 75 mg per day.
ture has shown that the predictive strength of mean arterial
pressure is moderate [4]. In our study also, we realized that Also, the trial showed that in resource-constrained set-
the baseline mean arterial pressure was higher in women tings where availability of biomarkers for determination of
who developed PE compared to those who did not. women at high risk of preeclampsia is very much restricted,
screening by history and mean arterial pressure can be of
The incidence of foetal growth restriction among women great help.
who developed PE was lower in women given 150 mg aspi-
rin, although the difference was not statistically significant Acknowledgements The authors of the study acknowledge the intra-
[19]. Other foetal outcomes did not show any significant mural study grant provided by the Research cell of King George’s
difference in this trial as shown in Table 4. Medical University (Grant No. 1125/R cell-16).

A study was carried out by Ebrashy et al. [21] on 139 Compliance with Ethical Standards
women found to be at high risk of preeclampsia through
uterine artery Doppler at 11–14 weeks, and 75 mg aspirin Conflict of interest There is no conflict of interest among the authors.
was started in one arm versus placebo in other. They found There is no financial relationship with any organization.
that in the aspirin group, the incidence of preeclampsia was
35%, severe PE 7.7% and foetal growth restriction 18.9%, Ethical Statement All procedures followed were in accordance with
while in this trial among the 91 women who were given the ethical standards of the responsible Institutional Committee on
150 mg, the incidence of PE was 6.5%, severe PE 2.1% and human experimentation and with the Helsinki Declaration of 1975, as
early-onset PE 1%. The incidence in the control group of revised in 2008 (5).
the study by Ebrashy et al. showed a significantly higher
incidence of PE, severe PE and foetal growth restriction. Informed consent Informed consent was obtained from all patients for
It indicates that aspirin is effective in a dose of 75 mg also; being included in the study.
however, the efficacy increases with a doubling of dose.
References
There were no reported side effects noted in the form
of bleeding or peptic ulcer in both the groups. Similar to 1. Cunningham GF, Leveno KJ, Bloom SL, et al. Williams obstetrics.
ASPRE trial, our trial showed that the incidence of preec- 24th ed. New York: McGraw-Hill; 2014.
lampsia in the 150 mg aspirin group was lower than that in
75 mg group; however, we also realized that in our study 2. Plasencia W, Maiz N, Bonino S, et al. Uterine artery Doppler at
population, 150 mg aspirin also helps to lessen PE develop- 11 + 0 to 13 + 6 weeks in the prediction of pre-eclampsia. Ultra-
ing between 34 and 37 weeks. sound Obstet Gynecol. 2007;30:742–9.

The main limitation of the study is the small sample size. 3. Yu CKH, Khouri O, Onwudiwe N, et al. Prediction of pre-eclamp-
The study if carried out at a larger scale could lead to better sia by uterine artery Doppler imaging : relationship to gestational
inference and impact. Also, incorporation of biochemical age at delivery and small for gestational age. Ultrasound Obstet
markers in the form of PAPPA and PLGF would have helped Gynecol. 2008;31:310–3.
to more precisely predict the women having higher risk of
preeclampsia. The biggest strength is the direct comparison 4. Walsh CA, Bakshi LV. Mean arterial pressure and prediction of
of the most commonly used dosage with the recommended pre-eclampsia. Br Med J. 2008;336(7653):1079–80.

13

Pilot Interventional Study Comparing Fetomaternal Outcomes 29

5. Akolekar R, Syngelaki A, Sarquis R, et al. Prediction of early, 19. Rolnik DL, Wright D, Poon LC, et al. Aspirin versus placebo in
intermediate and late preeclampsia from maternal factors, bio- pregnancies at high risk for preterm preeclampsia. N Engl J Med.
physical and biochemical markers at 11–13 weeks. Prenat Diagn. 2017;377(7):613–22.
2011;31:66–74.
20. Kuc S, Wortelboer EJ, Rijn BB, et al. Evaluation of 7 serum bio-
6. Goetzinger KRG, Singla A, Gerkowicz S, et al. Predicting the risk markers and uterine artery doppler ultrasound for first-trimester
of pre-eclampsia between 11 and 13 weeks gestation by combin- prediction of preeclampsia: a systematic review. Obstet Gynecol
ing maternal characteristics and serum analytes, PAPP-A and free Surv. 2011;66(4):225–39.
β-Hcg. Prenat Diagn. 2010;30(12–13):1138–42.
21. Ebrashy A, Ibrahim M, Marzook A, et al. Usefulness of aspirin
7. Gomez O, Figuerats F, Fernandez S, et al. Reference ranges for therapy in high-risk pregnant women with abnormal uterine artery
uterine artery mean pulsatility index at 11–41 weeks of gestation. doppler ultrasound at 14–16 weeks pregnancy: randomized con-
Ultrasound Obstet Gynecol. 2008;32:128–32. trolled clinical trial. Croat Med J. 2005;46(5):826–31.

8. Ridding G, Schluter PJ, Hyett JA, et al. Uterine artery pulsatality 22. Poon LCY, Nikos A, Kametas NA, et al. Mean arterial pressure at
index assessment at 11–13+6 weeks gestation. Fetal Diagn Ther. 110 to 136 weeks in the prediction of preeclampsia. Hypertension.
2014;36:299–304. 2008;51:1027–33.

9. Askie LM, Lelia D, Henderson SDJ, et al. Antiplatelet agents for Publisher’s Note Springer Nature remains neutral with regard to
prevention of pre-eclampsia: a metaanalysis of individual patient jurisdictional claims in published maps and institutional affiliations.
data. Lancet. 2007;369(9575):1791–8.
About the Author
10. Bujold E, Roberge S, Lacasse Y, et al. Prevention of preeclampsia
and intrauterine growth restriction with aspirin started in early Dr. Namrata Kumar did her
pregnancy : a metaanalysis. Obstet Gynecol. 2010;116:402–14. MBBS from M.L.N Medical
College, Allahabad, followed by
11. Roberge S, Villa P, Nicolaides K, et al. Early administration of MD in Obstetrics and Gynaecol-
low-dose aspirin for the prevention of preterm and term preec- ogy from King George’s Medical
lampsia: a systematic review and meta-analysis. Fetal Diagn Ther. University, Lucknow. She has
2012;31:141–6. done postdoctoral certificate
course in high-risk pregnancy
12. Caron N, Rivard GE, Michon N, et al. Low dose ASA response and foetal medicine from Sanjay
using the PFA-100 in women with high risk pregnancy. J Obstet Gandhi Postgraduate Institute of
Gynecol Can. 2009;31(11):1022–7. Medical Sciences, Lucknow. She
has got special expertise in foetal
13. Rey E, Rivard GE. Is testing for aspirin response worthwhile medicine and has got accredita-
in high risk pregnancy? Eur J Obstet Gynecol Reprod Biol. tion from The Fetal Medicine
2011;157(1):38–42. Foundation, UK. She is presently
Associate Professor in the
14. Norgard M, Puho E, Czeizel AE, et  al. Aspirin use dur- Department of Obstetrics and Gynaecology at King George’s Medical
ing early pregnancy and risk of congenital abnormalities: a University, Lucknow, and has got keen interest in management of high-
population based case control study. Am J Obstet Gynecol. risk pregnancy. She has got several papers and publications to her credit
2005;192(3):922–3. and has presented her work in various conferences. She is a young,
dynamic teacher, clinician and researcher.
15. Poon LC, Syngelaki A, Akolekar R, et al. Combined screening for
preeclampsia and small for gestational age at 11–13 weeks. Fetal
Diagn Ther. 2013;33:16–27.

16. Gorman N, Wright D, Syngelaki A, et al. Competing risks model
in screening for preeclampsia by maternal factors and biomarkers
at 11–13 weeks gestation. Am J Obstet Gynecol. 2016;214(1):103.

17. Roberge S, Nicolaides K, Demers S, et al. The role of aspirin
dose on the prevention of preeclampsia and fetal growth restric-
tion: systematic review and meta-analysis. Am J Obstet Gynecol.
2017;216(2):110–20.

18. Wright D, Akolekar R, Syngelaki A, et al. A competing risks
model in early screening for preeclampsia. Fetal Diagn Ther.
2012;32:171–8.

A liations

Namrata Kumar1,3 · Vinita Das1 · Anjoo Agarwal1 · Amita Pandey1 · Smriti Agrawal1 · Amrita Singh2

1 Department of Obstetrics and Gynaecology, King George’s 3 Lucknow, India
Medical University, Lucknow, India

2 Department of Obstetrics and Gynaecology, Era Lucknow
Medical College, Lucknow, India

13































































Is performing sacrospinous fixation with vaginal hysterectomy 61
Fig.2 Comparison of recur-
rence rates after VH-PFR-M
and VH-PFR-M-SSF using
Kaplan-Meier curves. There
was no statistical difference
between the two groups

Table 4 Outcome measures of VH-PFR-M VH-PFR-M-SSF p value
stage 3 subjects n = 106 n = 34
0.81
Recurrence stage 3 only n (%) 7 (6.6%) 1 (2.9%) 1.00
Intra-OP complications n (%) 0 (0%) 0 (0%) 0.81
Early ( < 1 week) complications n (%) 26 (24.5%) 9 (26.5%) 0.86
Late ( > 1–6 week) complications n (%) 17 (16.0%) 5 (14.7%) 0.02
Haematocrit change (mean ± sd) 0.8 ± 1.5 1.5 ± 1.6 0.16
Duration of surgery in hours (mean ± sd) 1.9 ± 0.7 2.1 ± 0.8 0.41
Duration of hospital stay in days (mean ± sd) 5.1 ± 0.5 5.2 ± 0.9 0.12
Duration of follow-up in months (mean ± sd) 20.7 ± 9.5 17.9 ± 7.2

The literature suggested higher rates of cystocele after Mesh surgery is an alternative choice in such patients,
VH-PFR-SSF. Colombo and Milani et al. reported a recur- but it can add to the cost and lead to mesh-related complica-
rence rate of 33% in patients who had undergone VH-PFR- tions resulting in pain and requiring re-operations [6, 8]. We
SSF. (1) Similarly, Allahdin et al. found a recurrence of added SSF to VH-PFR-M in patients with stage 3 prolapse
28% at 12 months, Maher et al. found a recurrence of 33% with prominent bulge symptoms and stage 4 prolapse. The
at 19 months and Sze et al. found a recurrence of 18% at procedure is relatively cheap with the requirement of just
24 months in patients who had undergone VH-PFR-SSF one extra suture material and safe as patient’s sacrospinous
which is higher than our recurrence in VH-PFR-M-SSF ligament is used for additional strength [9].
though our group included only patients with more advanced
prolapse. (1) Our study showed similar anterior compart- Prior studies have conflicting views on the role of SSF
ment recurrence patterns in Group 1 and Group 2, 3.8% in with regard to operating time, blood loss, complications and
VH-PFR-M and 2.4% in VH-PFR-M-SSF, which is lesser prolapse recurrence [1, 5, 10, 11]. Elif et al. found statisti-
when compared to other studies. Posterior compartment and cally significant increase in operating time, hospital stay and
apex recurrence in the VH-PFR-M-SSF group are compara- blood loss requiring blood transfusion in the SSF group [6].
ble to other studies. Colombo and Milani et al. found SSF inferior to McCall’s
culdoplasty in terms of operative time, blood loss and recur-
rence. (1) But our study shows no statistically significant

13

62 Rajan et al.

difference in the operating time, intraoperative complica- and late ( < 6 weeks) and duration of hospital stay, suggest
tions, immediate and late post-operative complications or that this technique is worth pursuing and we intend to follow
hospital stay between both groups. Though there is a statis- up these patients for a longer duration.
tically significant difference in the blood loss, none of the
patients in the VH-PFR-M-SSF group required blood trans- Conclusion
fusion. The patients in the VH-PFR-M-SSF group included
patients with more advanced stage of prolapse which could On the basis of this study, it may be concluded that this pro-
also account for the relative increase in the blood loss. cedure (VH-PFR-M-SSF) could be recommended in more
advanced stages of prolapse, without any significant increase
Amongst the significant complications in the SSF group, in cost, procedure-specific complications, overall complica-
Pasley et al., Hoffman et al. and Benson et al. found 2% tions, hospital stay or recurrence rate.
bladder and bowel injuries in their studies independently.
(1) Paraiso et al. found significant blood loss requiring blood Funding This article was internally funded by hospital resources.
transfusion in 8% of their patients. (1) Benson et al. found
post-operative urinary retention to be as high as 75%, while Compliance with Ethical Standards
Paraiso et al. and Hoffman et al. found it to be between
10 and 12%. Meschia et al. found cuff infections in about Conflict of interest All authors declare that they have no conflict of
14% patients, while Benson et al. found UTI amongst 21% interest.
patients of their study group. Maher et al. reported nerve Ethical Approval This research involved human participants. The study
injuries in 36% patients. (1) Elif et al. reported bladder has been conducted after approval from Ethical and Research commit-
injury in 5.8% patients in VH-PFR and rectal injury in 6.2% tee of Believers Church Medical College, Thiruvalla, Kerala, India. All
patients and vascular injury in 19% patients of VH-PFR- procedures followed were in accordance with the ethical standards of
SSF, respectively. (6) Amongst the patients who underwent the responsible committee on human experimentation (institutional and
mesh procedures, Lopes et al. found mesh erosions to be as national) and with the Helsinki Declaration of 1975, as revised in 2008.
high as 50%, while Lo et al. reported 20% cases of mesh Informed consent Written Informed Valid consent was obtained from
shortening. (1) In our study group, there were no bladder and all patients prior to the procedure.
bowel injuries and no nerve or vascular injuries, and none
of the patients required blood transfusion. Urinary retention References
was found only in 0.5% of our entire study group, though
vault infection and UTI were comparable with the literature. 1. Tseng L-H, Chen I, Chang S-D, et al. Modern role of sacrospinous
ligament fixation for pelvic organ prolapse surgery—A systemic
The recurrence rate for the two groups was similar review. Taiwan J Obstet Gynecol. 2013;52(3):311–7.
(p = 0.23) despite the fact that VH-PFR-M-SSF was done
only for patients with stage 3 prolapse and having prominent 2. Wan OY, Chan SS, Cheung RY, et al. Mesh-related complications
bulge symptoms and stage 4 prolapse. All known risk fac- from reconstructive surgery for pelvic organ prolapse in Chinese
tors, except stage of presenting prolapse, were equally dis- patients in Hong Kong. Hong Kong Med J Xianggang Yi Xue Za
tributed for the two types of surgeries. Stratification based on Zhi. 2018;24(4):369–77.
stage revealed that VH-PFR-M-SSF was not done on those
with stage 2 prolapse and VH-PFR-M was not done on those 3. Zhang H, Zhu L, Xu T, et al. Utilize the simplified POP-Q sys-
with stage 4 prolapse. Therefore, on restricting to patients tem in the clinical practice of staging for pelvic organ prolapse:
with stage 3 prolapse, those who underwent VH-PFR-M- comparative analysis with standard POP-Q system. Zhonghua Fu
SSF had 57% lower risk of developing a prolapse compared Chan Ke Za Zhi. 2016;51(7):510–4.
to those who underwent VH-PFR-M only. However, the
reduced risk was not statistically significant. 4. Pax C-M. Vaginale Prolapshysterektomie mit Scheidengrundfixa-
tion und Zystozelenkorrektur. 2016 [cited 2019 Feb 3]; Available
The lack of significance could be due to inadequate sam- from: https://refubium.fu-berlin.de/handle/fub188/2991
ple size. Although we began with an adequate sample based
on the assumption that recurrence amongst those who under- 5. Heft JS, Adam RA. Apical Prolapse: Is There a Best Approach?
went VH-PFR-M would be 15% and for those who under- Curr Bladder Dysfunct Rep. 2018;13(3):101–10.
went VH-PFR-SSF would be 33%, based on prior studies
(1), the reduced recurrence rate in the two groups rendered 6. Ağaçayak E, Yaman Tunç S, İçen MS, et al. Should we add uni-
it inadequate. Further studies with larger sample size and lateral sacrospinous ligament fixation to vaginal hysterectomy in
longer follow-up are required to establish VH-PFR-M-SSF management of stage 3 and stage 4 pelvic organ prolapse? Turk J
as a procedure of choice for advanced prolapse. However, Obstet Gynecol. 2015;12(3):144–50.
the reduced recurrence rates and the comparable rates of
complications, including intraoperative, early ( < 1 week) 7. Alas A, Chandrasekaran N, Devakumar H, et al. Advanced uter-
ovaginal prolapse: is vaginal hysterectomy with McCall culdo-
plasty as effective as in lesser degrees of prolapse? Int Urogyne-
cology J. 2018;29(1):139–44.

13

Is performing sacrospinous fixation with vaginal hysterectomy 63

8. Lee D, Chang J, Zimmern PE. Iatrogenic Pelvic Pain: Surgi- Oncologist and Laparoscopic Gynaecologist, and as Assistant Professor
cal and Mesh Complications. Phys Med Rehabil Clin N Am. in Dept of Obstetrics and Gynaecology at Believers Church Medical
2017;28(3):603–19. College Hospital, Thiruvalla, Kerala. She has published original
research articles in peer reviewed and indexed journals, and is actively
9. Vitale SG, Laganà AS, Noventa M, et al. Transvaginal Bilateral involved in training of undergraduate and postgraduate students.
Sacrospinous Fixation after Second Recurrence of Vaginal Vault
Prolapse: Efficacy and Impact on Quality of Life and Sexuality.
BioMed Res Int [Internet]. 2018 Feb 28 [cited 2019 Feb 3];2018.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC5851336/

10. Al-Badr A, Perveen K, Al-Shaikh G. Evaluation of Sacros-
pinous Hysteropexy vs. Uterosacral Suspension for the Treat-
ment of Uterine Prolapse: A Retrospective Assessment: SSHP
vs. USS for Uterine Prolapse. LUTS Low Urin Tract Symptoms.
2017;9(1):33–7.

11. Fairchild PS, Kamdar NS, Berger MB, et al. Rates of colpopexy
and colporrhaphy at the time of hysterectomy for prolapse. Am J
Obstet Gynecol. 2016;214(2):262.

Publisher’s Note Springer Nature remains neutral with regard to
jurisdictional claims in published maps and institutional affiliations.

About the Author

Dr. Deepa Rajan specialised in
gynaecologic oncology and min-
imal access surgery after qualify-
ing as an obstetrician and gynae-
cologist in 2008 from
Maharashtra University and
National Board of Examinations,
New Delhi. She has trained at
Gujarat Cancer Research Insti-
tute, Ahmedabad and Chang
Gung Memorial Hospital, Kaoh-
siung, Taiwan. She is working as
Consultant Gynaecologic

13

The Journal of Obstetrics and Gynecology of India (January–February 2020) 70(1):64–68
https://doi.org/10.1007/s13224-019-01268-6

ORIGINAL ARTICLE

Immediate Postpartum Intrauterine Device in HIV-Infected Women:
Experience from a Tertiary Care Center in Côte d’Ivoire

Edouard N’guessan1  · Franck Gbeli1 · Jean-Marc Dia1 · Privat Guie1 · Nguessan Kouame Roseline1

Received: 7 February 2019 / Accepted: 19 August 2019 / Published online: 18 October 2019
© Federation of Obstetric & Gynecological Societies of India 2019

Abstract
Background Immediate postpartum intrauterine device (PPIUD) is a good solution for reducing low contraceptive coverage
in developing countries. However, its use in HIV-infected women is poorly documented. The objective of this study was to
assess whether the risk of PPIUD complications was higher in HIV-infected women.
Methods A retrospective cohort study compared 64 HIV-infected women to 128 HIV-negative women who had had a PPIUD
at the University Hospital of Treichville between January 2016 and March 2017, with a match at the insertion time of the
PPIUD. The complications considered were pelvic pain, metrorrhagia and genital infections. Chi-squared test and relative
risk were used to investigate the association between HIV infection and PPIUD complications.
Results HIV-infected patients had an average age of 33.1 years, and 85.9% of them were on antiretroviral therapy. PPIUD
was inserted during cesarean section in 66.1% of cases. There was no significant association between HIV infection and
PPIUD complications (RR = 0.7, 95% CI [0.4–1.3], p = 0.3). The risk of genital infections was not increased in HIV-infected
women (RR = 0.6 [0.1–2.7], p = 0.7).
Conclusion HIV infection does not increase the risk of PPIUD complications. This effective contraceptive strategy can be
offered to HIV-infected women. It is therefore necessary to strengthen the training of maternity staff in the installation of
PPIUD.

Keywords HIV · AIDS infection · PPIUD · Copper IUD · Complications

Edouard N’guessan is a Lecturer in Department of Obstetrics and Introduction
Gynecology, Medical College and Research, Felix Houphouet-
Boigny University in Abidjan, Côte d’Ivoire; Franck Gbeli is a In most sub-Saharan countries, the prevalence of HIV/AIDS
resident in Department of Obstetrics and Gynaecology, University among women of childbearing age and the maternal mortal-
Hospital of Treichville, Abidjan, Côte d’Ivoire; Jean-Marc Dia is ity ratio are at levels of concern. According to UNAIDS,
a Lecturer in Department of Obstetrics and Gynecology, Medical nearly 60% of adults infected with HIV in this region are
College and Research, Felix Houphouet-Boigny University, women of childbearing age [1]. In addition, this region alone
Abidjan, Côte d’Ivoire; Privat Guie is a Professor and Head of the accounts for more than half of all maternal deaths worldwide
Department of Obstetrics and Gynecology, University Hospital each year [2].
of Treichville, Abidjan, Côte d’Ivoire. Simplice Anongba is
a honorary Professor and the past Head of the Department of Family planning by preventing unwanted pregnancies
Obstetrics and Gynecology, University Hospital of Treichville, prevents almost one-third of maternal deaths [3]. In HIV-
Abidjan Côte d’Ivoire. infected women, effective contraception prevents maternal
* Edouard N’guessan mortality and vertical transmission of HIV [4].

[email protected] Almost all countries in sub-Saharan Africa have low con-
1 Department of Obstetrics and Gynecology, University traceptive prevalence [5]. Thus, according to United Nations,
modern contraceptive prevalence in Côte d’Ivoire was only
Hospital of Treichville, 01 BP V3 Abidjan 01, Abidjan, 16.3% in 2017 [6].
Côte d’Ivoire
Moreover, in these countries, few women return to the
1 3Vol:.(1234567890) postnatal visit and the gravid-puerperium remains their main
moment of contact with the reproductive health services.

Immediate Postpartum Intrauterine Device 65

Hence in recent years the emphasis is laid on immediate value < 0.05 was accepted as the significance level. The risk
postpartum contraception, including the intrauterine device of PPIUD complications related to HIV infection was esti-
(IUD) and implant, to increase contraceptive coverage in mated by the calculation of relative risk with a 95% confi-
these developing countries. The IUD is a safe, effective and dence interval (95% CI).
inexpensive contraceptive method with good acceptabil-
ity in the immediate postpartum [7]. A Cochrane review The study being retrospective, it was not necessary to
also provided evidence regarding the safety and feasibility have the consent of patients. However, their confidentiality
of the IUD inserted in the immediate postpartum period has been respected.
[8]. Previous studies have shown that the IUD is safe for
women infected with stable HIV, that is, patients who have Results
no opportunistic infection or coexisting infection in progress
[9]. However, the IUD in these studies was not inserted in During the study period, 901 PPIUDs were inserted, 67
the immediate postpartum period. The objective of this study of which (that is 7.4%) in HIV-infected women. But 64 of
was therefore to assess whether the risk of complications them were involved in the analysis, with an eligibility rate
after insertion of PPIUD was higher in HIV-infected women of 95.5% (Fig. 1).
than in uninfected women.
Table 1 presents the socio-demographic features of HIV-
Materials and Methods infected women in whom a PPIUD was inserted. Their mean
age was 33.1 ± 5.8 years. They had a median parity of 3 with
This is a retrospective cohort study carried out in the obstet- extremes at 0 and 7. Among them, 24 (37.5%) had scarred
rics and gynecology department of the University Hospital uterus.
of Treichville between January 2016 and March 2017. It
focused on women who refused the use of condom dur- The medical data of the infected women in whom a
ing sexual intercourse but who accepted the insertion of a PPIUD was inserted are summarized in Table 2. For 53.1%
PPIUD with a follow-up of at least 6 weeks during the study of women, the HIV-positive status was known before preg-
period. The IUD used was TCu 380A, and the insertion was nancy and 85.9% of them were on antiretroviral therapy. The
done in eligible patients after counseling. An ultrasound IUD was inserted in the majority of them (65.6%) during
was performed 6 weeks after the insertion of the PPIUD to cesarean section. The median duration of patients follow-up
check its right location. Among these women, those who was 8 weeks (extremes at 6 and 24 weeks).
were HIV-infected were identified and compared to HIV-
negative women with a matching time of insertion of the The incidence of PPIUD complications was 18.7% in
PPIUD and at a rate of 1 HIV-positive woman for 2 HIV- HIV-infected women versus 25.8% in the control group. This
negative women. was a genital infection in two HIV-infected women (3.1%)
and seven uninfected women (5.5%).
The criteria for non-inclusion were as follows: lost to
follow-up patients, cases of IUD expulsion, incomplete At the statistical analysis, HIV infection was not associ-
files and patients with advanced stages of the HIV infection ated with a significant increase in the overall incidence of
(coexisting infection or an extremely low CD4 count). PPIUD complications (RR = 0.7 [0.4–1.3], p = 0.3). In addi-
tion, the risk of complications occurring in isolation was
The data needed for our study were collected using a similar in both groups (Table 3).
standardized questionnaire from the birth registry and med-
ical records. The variables studied included socio-demo- Total of PPIUDs inserted, N=901
graphic data and medical data related to HIV infection (and
PPIUD). PPIUD complications that were sought were pelvic HIV negative women, n= 835 HIV positive women, n=67
pain, bleeding and genital infections.
Exclusion
Diagnosis of genital infections was based on the follow- Lost to follow up, n=1
ing criteria: abnormal vaginal discharge with positive sexu- PPIUD expulsion, n= 2
ally transmitted infection from vaginal swabs or pelvic ten-
derness with at least one of the following signs: temperature Patients included in the study, n= 64
above 38 °C and positive C-reactive protein.
Fig. 1 Enrollment process in the study
Data analysis was performed using SPSS.22 software.
The relationship between PPIUD complications and HIV
infection was investigated using the Pearson Chi-squared
test or Fischer’s exact test (when recommended). A p

13

66 N’guessan et al.

Table 1 Socio-demographic features of HIV-infected women with Table 2 Medical data of HIV-infected women with PPIUDs (n = 64)
PPIUD (n = 64)
Features Number Percentage (%)
Features Number Percentage (%) (N = 64)
(N = 64)
Time of HIV testing
Age (years) 1 1.6  Before the current pregnancy 34 53.1
  < 20 21 32.8  During the current pregnancy 24 37.5
 20–29 36 56.2  At the maternity hospital 6 9.4
 30–39 Antiretroviral therapy
 ≥ 40 6 9.4  Yes 55 85.9
Parity  No 9 14.1
 Primiparous (1 delivery) 4 6.2 CD4 count (elements/ml)
 Paucipara (2–3 deliveries) 25 39.1  200–349 7 10.9
 Multiparous (≥ 4 deliveries) 35 54.7  ≥ 350 45 70.3
Occupation  Unspecified 12 18.8
 Liberal 36 56.2 Mode of admission
 Housewife 20 31.3  Evacuated 35 54.7
 Employee  Followed up in the department 29 45.3
 Pupil/student 6 9.4 Time of counseling for PPIUD
School education level 2 3.1  During prenatal consultations 15 23.4
 Uneducated  In labor lag phase 48 75.0
 Primary school level 19 29.7  Immediate postpartum 1
 Secondary school level 18 28.1 Time of insertion of PPIUD 1.6
 Higher level 20 31.3  Post-placental 14
Marital status 7 10.9  Immediate postpartum 8 21.9
 Single woman  During cesarean section 42 12.5
 Married woman 6 9.4 Duration of follow-up 65.6
Scarred uterus 58 90.6  8 weeks 25
 Yes  ≥ 9 weeks 39 60.9
 No 24 37.5 39.1
40 62.5

Discussion was associated with a more rapid progression of HIV infec-
tion [13]. Unlike the copper IUD, hormonal contraceptives
In this study, HIV infection was not associated with can affect the effectiveness of antiretrovirals through drug
increased risk of PPIUD complications. In fact, our analysis interactions [14, 15]. However, despite the lack of effect of
found that the rate of complications of PUPs in HIV-infected the copper IUD on the course of HIV infection, it is recom-
women and women without HIV was similar. Better still, the mended to limit its indications before the stage of AIDS
risk of genital infections after insertion of the PPIUD has disease [16].
not increased in HIV-infected women. There is insufficient
data in the literature to assess the safety of the IUD inserted These results demonstrate the safety of copper IUD in
in the immediate postpartum period in HIV-infected women. HIV-positive women in terms of the overall incidence of
The available data concern only the inserted IUD in HIV- complications, incidence of genital infections and the pro-
infected women outside this critical period [10, 11]. Thus, gression of HIV infection. These results also indicate that
a prospective cohort study assessed the risk of complica- PPIUD, is a deemed effective and safe contraceptive strat-
tions after insertion of the copper IUD in 156 HIV-infected egy, which may be appropriate for women living with HIV.
women compared to 493 uninfected women in two family
planning clinics in Nairobi. The authors noted that the risk Conclusion
of IUD complications was not significantly higher in HIV-
infected women [12]. The benefits of safe and effective contraception for women
living with HIV are enormous as they encompass the pre-
Furthermore, a controlled randomized trial comparing vention of both maternal and pediatric AIDS. In this study,
copper IUD and hormonal contraception for 2 years in 599 the insertion of PPIUD in HIV-positive women did not
HIV-infected women showed that hormonal contraception

13

Immediate Postpartum Intrauterine Device 67

Table 3 Association between PPIUD complica- Type of complications Genital infections
HIV infection and PPIUD tions Pain Metrorrhagia Yes No
complications Yes No Yes No Yes

No

HIV + (n = 64) 12 (18.7%) 52 8 56 2 62 2 62
HIV − (n = 128) 33 (25.8%) 95
RR [95% IC] 0.7 [0.4–1.3] 16 112 10 118 7 121
p 0.3
1 [0.4–2.2] 0.4 [0.1–1.8] 0.6 [0.1–2.7]

1.0 0.3 0.7

RR relative risk, CI confidence interval, p p value

significantly increase the risk of IUD-related complications. 3. Ahmed S, Li Q, Liu L, et  al. Maternal deaths averted by
In addition, HIV-infected women had no increased risk of contraceptive use: an analysis of 172 countries. Lancet.
developing genital infections after PPIUD insertion. 2012;380(9837):111–25.

This study therefore suggests that IUD insertion in the 4. Sarnquist CC, Moyo P, Stranix-Chibanda L, et al. Integrating fam-
immediate postpartum is safe for HIV-infected women. In an ily planning and prevention of mother to child HIV transmission
area of high prevalence of HIV infection such as ours, these in Zimbabwe. Contraception. 2014;89(3):209–14.
results demonstrate that PPIUD should be considered as one
of the appropriate contraceptive options for women living 5. Cahill N, Sonneveldt E, Stover J, et  al. Modern contracep-
with HIV. This requires developing strategies to ensure the tive use, unmet need, and demand satisfied among women of
continued availability of IUDs in maternity hospitals and to reproductive age who are married or in a union in the focus
train maternity care staff in counseling and PPIUD insertion. countries of the family planning 2020 initiative: a systematic
Further studies are needed to deepen the long-term impact analysis using the family planning estimation tool. Lancet.
of PPIUD on this population at risk. 2018;391(10123):870–82.

Compliance with Ethical Standards 6. United Nations (UN), Department of Economic and Social Affairs,
Population Division. World Family Planning Highlights 2017.
Conflict of interest The authors declare that they have no conflict of New York, UN; 2017. https://www.un.org/en/development/desa/
interest. population/publications/pdf/family/WFP2017_Highlights.pdf.
Accessed 10 Aug 2019.
Funding None.
7. Pfitzer A, Mackenzie D, Blanchard H, et al. A facility birth can
Ethical Approval All procedures followed were in accordance with the be the time to start family planning: postpartum intrauterine
ethical standards of the institutional ethics committee and with the device experiences from six countries. Int J Gynecol Obstet.
Declaration of Helsinki 1975, as revised in 2008 (5). Ethical consent 2015;30:S54–S61.
for the work has been given by the ethical committee of our hospitals.
8. Grimes D, Schulz K, Van Vliet H et al. Immediate postpartum
Informed Consent Due to the retrospective nature of the study, insertion of intrauterine device: a systematic review. Cochrane
patients’ consent was not required. However, the confidentiality of Database Syst Rev. 2001(2):CD003036.
patients’ records was respected.
9. Kakaire O, Byamugisha JK, Tumwesigye NM, et al. Intrauter-
References ine contraception among women living with human immunode-
ficiency virus: a randomized controlled trial. Obstet Gynecol.
1. UNAIDS. Fact sheet—latest statistics on the status of the AIDS 2015;126(5):928–34.
epidemic. Geneva: UNAIDS; 2017.
10. Tepper NK, Curtis KM, Nanda K, et al. Safety of intrauterine
2. Hogan MC, Foreman KJ, Naghavi M, et al. Maternal mortal- devices among women with HIV: a systematic review. Contracep-
ity for 181 countries, 1980–2008: a systematic analysis of tion. 2016;94(6):713–24.
progress towards millennium development goal 5. Lancet.
2010;375(9726):1609–23. 11. Haddad LB, Feldacker C, Jamieson DJ, et al. Medical eligibility,
contraceptive choice, and intrauterine device acceptance among
HIV-infected women receiving antiretroviral therapy in Lilongwe
Malawi. Int J Gynaecol Obstet. 2014;126(3):213–6.

12. Morrison CS, Sekadde-Kigondu C, Sinei SK, et al. Is the intra-
uterine device appropriate contraception for HIV-1-infected
women? Br J Obstet Gynaecol. 2001;108:784–90.

13. Stringer EM, Kaseba C, Levy J, et al. A randomized trial of the
intrauterine contraceptive device vs hormonal contraception in
women who are infected with the human 8 infectious diseases in
obstetrics and gynecology immunodefficiency virus. Am J Obstet
Gynecol. 2007;197(2):144.e1–.e8.

14. Robinson JA, Jamshidi R, Burke AE. Contraception for
the HIV-positive woman: a review of interactions between

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hormonal contraception and antiretroviral therapy. Infect Dis HIV-infected women. He is also interested in the epidemiological,
Obstet Gynecol. 2012; 2012: 890160. clinical and prognostic particularities of cervical cancer in women liv-
15. Leticee N, Viard JP, Yamgnane A, et al. Contraceptive failure of ing with HIV.
etonogestrel implant in patients treated with antiretrovirals includ-
ing efavirenz. Contraception. 2012;85(4):425–7.
16. Vidal F, Paret L, Linet T, et  al. Intrauterine contraception:
CNGOF contraception guidelines. Gynecol Obstet Fertil Senol.
2018;46(12):806–22.
Publisher’s Note Springer Nature remains neutral with regard to
jurisdictional claims in published maps and institutional affiliations.

About the Author

Edouard N’guessan is a professor-
researcher at the Félix
Houphouët-Boigny University,
Abidjan Côte d’Ivoire. He is also
a hospital practitioner in the
department of Obstetrics and
Gynecology, University Hospital
of Treichville, Abidjan, Côte
d’Ivoire and a focal point for the
prevention of mother-to-child
HIV transmission in this hospi-
tal. His research studies focus on
HIV PMTCT, but also on the
reproductive health of

13

The Journal of Obstetrics and Gynecology of India (January–February 2020) 70(1):69–77
https://doi.org/10.1007/s13224-019-01273-9

ORIGINAL ARTICLE

Laparoscopic In-Bag Morcellation Compared with Conventional
Morcellation of Myomas and Uterus with Myomas

Prakash H. Trivedi1,2  · Soumil Trivedi1,2 · Sandeep Patil3

Received: 25 December 2018 / Accepted: 3 September 2019 / Published online: 9 December 2019
© Federation of Obstetric & Gynecological Societies of India 2019

Abstract
Study Objective To evaluate contained bag electromechanical morcellation for removal of myomas and uterus with myomas,
laparoscopically (Study group B), and compare it with uncontained laparoscopic morcellation (Control group A) in patients
with similar parameters done earlier.
Design Retrospective Cohort Comparative Study (Canadian Task Force 2-1).
Setting Advanced Gynaecologic MAS, university recognized tertiary centre, Mumbai, India.
Patients 720 women had laparoscopic removal of myomas or large uterus with myomas during a study period of 6 years
(from 13 May 2012 to 14 August 2018) with contained bag electromechanical or conventional morcellation.
Interventions Laparoscopic hysterectomy, laparoscopic myomectomy, conventional uncontained morcellation, contained
in-bag morcellation.
Main Outcomes Measures Laparoscopic contained in-bag morcellation was compared with conventional morcellation of
myomas and uterus with large myomas during a study period of 6 years. Parameters assessed were operating time, time for
insertion of bag, morcellation of tissues and removal of bag, blood loss, complications, conversion to open surgery and his-
topathologic findings of tissues. In Group A, in the first 3 years, 355 women underwent uncontained morcellation. Myoma
size and weight varied from 5 cm to 26 cm and 200 g to 3740 g respectively. The myoma number ranged from 1 to 18. No
case of leiomyosarcoma was reported. In Group B, in the next 3 years, 365 women underwent contained bag morcellation
in 196 myomectomy cases and 169 hysterectomy cases. Myoma size and weight varied from 4 cm to 20 cm and 200 g to
2100 g respectively. The number of myomas varied from 1 to 17.
Results and Conclusion Laparoscopic contained bag morcellation for myomas and uterus with large myomas were evaluated.
In myomectomy group both conventional and in bag laparoscopic morcellation were comparable in terms of duration of the
surgery and blood loss. When all cases ( hysterectomy and myomectomy combined together) and cases of hysterectomy with
large fibroid were studied, laparoscopic in bag morcellation took less operative time and there was statistically significant
difference in operative time . No case of leiomyosarcoma was found in our study of 720 cases of myomas or uterus with
large myomas.

Keywords Morcellation · In bag morcellation · Contained morcellation · Myomectomy · Hysterectomy · Myoma

Dr. Prakash H. Trivedi is the Scientific Director of Dr. Trivedi’s 2 Department of Obstetrics and Gynecology, Rajawadi
Total Health Care Pvt. Ltd. & Aakar IVF Centre, Professor and Hospital, Mumbai, India
the Head of Department of Obstetrics and Gynaecology, Rajawadi
Hospital; Dr. Soumil Trivedi is a Speciality Medical Consultant 3 Yashadaa Hospital, Mumbai, India
(SMC) in Rajawadi Hospital; Consultant in Dr. Trivedi’s Total
Health Care Pvt. Ltd. & Aakar IVF Centre. Dr. Sandeep Patil 1 3Vol.:(0123456789)
is a DNB; FMAS Consultant & Partner in Yashadaa Hospital,
Bhandup Mumbai
* Prakash H. Trivedi

[email protected]
1 Aakar IVF-ICSI Centre, Dr. Trivedi’s Total Health Care

Pvt. Ltd., 1, 2, 3 Gautam Building, Tilak Road, Opp Balaji
Temple, Ghatkopar East, Mumbai 400077, India

70 Trivedi et al.

Table 1 Sample under observation Control group All patients had standard preoperative work-up, sonog-
Study group (N = 355) raphy and Color Doppler prior to surgery for diagnosis and
(N = 365) mapping of myomas. MRI was not done as a routine due to
151 (42.5%) cost factor and limited utility.
Myomectomy 196 (53.6%) 204 (57.4%)
Hysterectomy 169 (46.4%) Inclusion Criteria for the Study

Introduction 1. Patients with fibroids not responding to medical treat-
ment for infertility or excessive bleeding requiring
After laparoscopic morcellation for fibroid and large uterus myomectomy to conserve the uterus.
was accepted [1], a controversy erupted when one case of lei-
omyosarcoma was diagnosed in a patient of laparoscopic hys- 2. Patients needing hysterectomy with uterus more than
terectomy in which morcellation lead to spread of sarcoma 14-weeks size with fibroid or hysterectomy in previous
with significant morbidity. This brought a halt in laparoscopic caesarean section, needing bisection, coring or cutting
morcellation followed by restricted use with black box warn- the uterus for vaginal removal.
ing on laparoscopic morcellation by USFDA in 2014 [2].
3. Patients keen for minimal access laparoscopic surgery.
Though the risk of myomectomy or removal of large 4. No high-risk factors disallowing laparoscopic surgery.
uterus involves many steps before morcellation, which are 5. Patients who consented after duly understanding the pros,
same with open or laparoscopic surgery yet, morcellation is
blamed for spread of cells. cons and risk of spread of pathology by removing tissue
laparoscopically after receiving information about alter-
In view of USFDA caution with main objective of accept- native techniques.
ance and safety, we undertook a comparative study at Total
Health Care Centre, Mumbai, India, to evaluate 365 cases Exclusion
of laparoscopic contained bag morcellation of myomas or
large uterus with myoma from 14 May 2015 to 14 August 1. Any case requiring morcellation for removal of uterus,
2018 (Group B) with the earlier technique of uncontained vaginal or laparoscopic, but with no myomas.
laparoscopic morcellation from 13 May 2012 to 13 May
2015 in 355 similar cases (Group A) (Table 1). 2. Any uterus with myomas which was removed intact
vaginally, where no morcellation, bisection, coring or
Materials and Methods cutting of uterus was needed.

Patients 3. Any uterus with myoma of more than 30 weeks in size
or myoma more than 20 cm, in the study group.
Group A
Total Healthcare Method is Very Speci c
One hundred and fifty-one cases of laparoscopic myomec- with De ned Steps
tomy and 204 cases of laparoscopic hysterectomy with more
than 14-weeks size uterus were included. All patients were operated under general anaesthesia and in
modified lithotomy position.
Group B
Technique of Laparoscopic Myomectomy—151
One hundred and ninety-six cases of laparoscopic myomec- Cases (Group A)
tomy and 169 cases of laparoscopic hysterectomy with more
than 14-weeks size uterus were included. A 4-port laparoscopy with 10-mm primary port being
umbilical or 2 inches above the palpable size of uterus in
All cases, laparoscopic myomectomy or hysterectomy large pathology or uppermost point of vertical scar is done.
for large uterus with fibroids, required morcellation as an Three 5-mm accessory ports, 2 on the left, 9–10 cm apart
essential step for effective surgery. and 1 on right, higher than left lower port are taken. Dilute
vasopressin 20 units in 200 ml of normal saline is injected
All patients in both groups gave consent in writing prior [3], quantity of drug injected depends on the size of fibroid.
to recruitment in the study. Due approval of Institutional Horizontal incision on bulge of the myoma is made with
Ethics Committee was taken, which was granted. monopolar spatula or active blade of harmonic scalpel. For
a large fibroid, an elliptical incision is made to reduce dead
space for endosuturing.

Fibroid is stabilized with myoma screw and dissected
out with scissors or harmonic scalpel. Once separated, the

13

Laparoscopic In-Bag Morcellation 71

fibroid is placed at the ileo-caecal region. A check on the
number of specimens is kept.

Large myoma defects are closed in two layers with barbed
sutures. Myoma less than 4 cm is sutured in single layer in
interrupted fashion.

All separated myomas are removed using a 15-mm reusa-
ble morcellator from the left lower port, always under vision.
Morcellation site wound is closed with port closure sutures.

Technique of Laparoscopic Hysterectomy for Large
Uterus—204 Cases (Group A)

Port placement is like laparoscopic myomectomy. In all Fig. 1 Stomach-shaped multiport bag with ear-like tail
cases, the first step is clipping of the uterine artery at the Fig. 2 Bag edge introduced with sheath through left lower port
origin, after opening the retroperitoneum, with 5-mm silastic
clips to reduce bleeding and safeguarding ureter.

Usually harmonic is used for dissection and ligasure
5-mm vessel sealer is used for laparoscopic hysterectomy
[4] for uterus with large fibroids. Steps of laparoscopic hys-
terectomy, viz. coagulation and cutting of round ligaments
and cornual structures, opening of the utero-vesical fold of
peritoneum and pushing the bladder below the cervix, dis-
secting posterior peritoneum till utero-sacrals and incising
them, coagulation and cutting of uterine vessel complex and
cardinals ligaments, colpotomy and vault closure, are stand-
ardized. In previous caesarean, lateral window approach is
used to push bladder below cervix [5].

Laparoscopic morcellation is done from left lower port,
widened to 15 mm. Hemostasis and ureteric peristalsis are
checked.

Laparoscopic Myomectomy—196 Cases
and Laparoscopic Hysterectomy—169 Cases (Group
B)

The steps of laparoscopic myomectomy and laparoscopic
hysterectomy are as above. After separation of fibroid or
uterus, contained morcellation was done as follows:

Surgical Steps of Contained Bag Morcellation

Polyurethane stomach-shaped bag (Fig. 1) is used, it is avail- Fig. 3 Specimen placed into bag and bag edges drawn over the speci-
able in 3 sizes, with mouth of 13, 15 and 17 cm diameter men
and volume of 1.6, 2.1 and 2.6 L, respectively. Left lower
port is widened by 15-mm blunt obturator of morcellator. Assistant stabilizes 12 O’clock position of bag, and surgeon
A plastic open trocar comes with the sterile bag. Mouth of stabilizes 6 O’clock position to keep the mouth open, facing
the bag is held to fit in the open plastic trocar, inserted from the camera. Trendelenburg position is removed, and surgeon
left lower port, assistant holds the edge of the bag’s mouth holds the fibroid or uterus with a tenaculum and puts the
(Fig. 2), and surgeon removes the plastic open trocar. By
a series of horizontal pulls on the bag, it is brought in the
abdomen. Left lower port is replaced by 10-mm cannula
with reducer, and if gas leaked, towel clip is applied on skin.
After bag slided into the pelvis, mouth of bag is opened.

13

72 Trivedi et al.

Fig. 4 Flower-like mouth of bag retrieved through left lower port Fig. 6 Cannula re-introduced into opening in the tail and insufflation
started

Fig. 5 Ear-shaped tail rail-roaded into umbilical cannula Fig. 7 Morcellation of myoma or uterus done within bag which
replaces peritoneal cavity
specimen inside the bag. Multiple fibroids can thus be put
into the bag (Fig. 3). Once uterus or all fibroids are in, edges Fig. 8 Morcellation of multiple myoma in bag
of the mouth of the bag are held closed from assistant’s to
surgeon’s side. Lastly, lateral edge of the mouth close to the deflated, and by pulling the mouth of the bag from left lower
morcellation port is held and brought out, pulling a part of port, the entire bag is removed (Fig. 11). In all 365 cases,
the bag outside. Mouth of the bag is pulled out of the abdo-
men (Fig. 4). Next, duodenum-shaped tail is inserted in a
railroad fashion into the primary cannula (Fig. 5). Thus, the
mouth end is out of the left lower port and the tail end is out
of the primary port. This tail end has an opening, and 10-mm
cannula is inserted through it (Fig. 6). Once pneumoperito-
neum is created, CO2 through the primary cannula distends
the bag. Optics is passed which showed the specimen in the
bag. The entire peritoneal cavity and abdominal structures
are out of the bag. Morcellator of 15 mm with blunt trocar
is introduced through left lower port, after removing trocar
and introducing grasper. The entire specimen is morcellated
(Figs. 7, 8, 9).

Morcellator is removed, and primary cannula is withdrawn.
A knot is tied at the tail end of bag below the opening through
which the optics is passed (Fig. 10). Pneumoperitoneum is

13

Laparoscopic In-Bag Morcellation 73

Fig. 9 Large specimen of 1.83 kg post-morcellation in bag

Fig. 12 Bag filled with methylene blue to test for spillage and integ-
rity check

Table 2 Parameters evaluated (all cases)

Total (N = 720) Study group Control group P value
(N = 365) (N = 355)

Duration of surgery 104.8 ± 30.9 110.3 ± 33.5 P = 0.001*
(min) (significant)
P = 0.711*
Blood loss (ml.) 126.8 ± 46.3 128.6 ± 58.9 (not significant)
P = 1.000**
Intra-op. complica- 0 1 (0.5%) (not significant)
tions 6 (1.6%) 4 (1.1%) P = 0.561**
(not significant)
Post-op. complica-
tions

*Mann–Whitney U test/** Chi-square test

Fig. 10 Opening in tail secured with knot below and bag can be with- bag integrity was checked with 1.5litre of diluted methylene
drawn blue instilled in the bag (Fig. 12). Hemostasis is checked and
morcellation port is closed with port closure needle.

All patients were discharged in 48 h, and follow-up was
done clinically, with sonography and MRI after 6 months
and 1 year in 85% cases. No case of residual tumour, leio-
myosarcoma or leiomyomatosis was found.

Results

Fig. 11 Bag being pulled from left lower port with tail receding into Parameters such as duration of surgery, time for insertion
the umbilicus of bag, morcellation of tissues, removal of bag, blood loss,
complications, conversion to open surgery (Table 2, 3, 4, 5)
and histopathologic findings were analyzed. There were no
cases of leiomyosarcoma, 2 cases of symplastic tumor with
no malignancy were noted. In both Group A and Group B,
parameters like duration of surgery, blood loss and complica-
tions were studied and it was noted that contained morcel-
lation added safety.

13

74 Trivedi et al.

Table 3 Parameters evaluated (only myomectomy) Laparoscopic contained bag morcellation for myomas and
uterus with large myomas were evaluated. In myomectomy
Myomectomy Study group Control group P value group both conventional and in bag laparoscopic morcel-
(N = 196) (N = 151) lation were comparable in terms of duration of the surgery
and blood loss. When all cases (hysterectomy and myomec-
Duration of surgery 107.4 ± 24.1 107.1 ± 16.2 P = 0.319* tomy combined together) and cases of hysterectomy with
(min) (Not significant) large fibroid were studied it was noted that laparoscopic
P = 0.053* in bag morcellation took less operative time and there was
Blood loss (ml.) 130.8 ± 27.2 132.2 ± 14.9 (Not significant) statistically significant difference in operative time. No case
of leiomyosarcoma was found in our study of 720 cases of
Intra-op. complica- Nil Nil P = 0.561** myomas or uterus with large myomas.
tions 3 (1.5%) 3 (1.7%) (Not significant)
Demographic and clinical characteristics of patients, both
Post-op. complica- in group A and in group B have been presented (Table 5).
tions
Overall, laparoscopic contained electromechanical mor-
*Mann–Whitney U test/** Chi-square test cellation took 17 min of average time for insertion of bag,
putting specimen in the bag and removal of bag, regardless
Table 4 Parameters evaluated (only hysterectomy) of size, weight and number of fibroids. Overall time was
saved as scattering or spillage of any material was avoided.
Hysterectomy Study group Control group P value In the study group, bag was cut due to technical issue in
(N = 169) (N = 204) two patients followed by conventional morcellation and only
in one case open surgery was needed to remove very large
Duration of surgery 101.7 ± 37.1 112.7 ± 41.9 P < 0.001* fibroids.
(min) 122.2 ± 61.1 125.9 ± 76.8 (significant)
P = 0.875* It was observed that multiple fibroids as many as 17
Blood loss (ml.) (not significant) of variable size and weight, as big as 20  cm and very
P = 1.000** large uterus with fibroids up to 30  weeks weighing till
Intra-op. complica- 0 1 (0.6%) (not significant) 2100  g, can be accommodated in the bag for contained
tions 3 (1.7%) 1 (0.6%) P = 0.485** morcellation (Table 5).
(not significant)
Post-op. complica-
tions

*Mann–Whitney U test/**Chi-square test

Table 5 Demographic and clinical characteristics of patients

Study group Control Group Total
(N = 365) (N = 355) (N = 720)
Myomectomy Myomectomy
(N = 196) Hysterectomy (N = 151) Hysterectomy
(N = 169) (N = 204)

Age (years) 33.5 ± 6.6 45.8 ± 8.4 31.0 ± 4.6 45.7 ± 7.2 39.4 ± 9.6
(27–59)
No. of fibroids 2 (1–17) 6 (1–12) 2 (1–18) 6 (1–13) 3.9 ± 2.3
(1–18)
Size of fibroids (cm) 7.2 ± 1.9 9.0 ± 2.9 7.2 ± 2.3 9.6 ± 3.3 Median = 4
8.3 ± 2.9
Weight of fibroid/specimen (g) 400 1000 350 1000 (5.5 ± 18.0)
(200–2100) (300–2100) (200–2200) (300–3740) Median = 7
Hb (g/dL) 700.7 ± 433.9
10.7 ± 1.0 11.2 ± 1.1 10.5 ± 0.8 11.1 ± 1.1 (200–3740)
Medical conditions Median = 450
Surgical conditions 9 (4.5%) 61 (36.2%) 3 (1.7%) 63 (31.0%) 10.9 ± 1.1
Intra-op. complications 23 (11.9%) 4 (2.6%) 17 (11.3%) 16 (7.7%) (8.5–14.0)
Post-op. complications Nil 0 Nil 1 (0.7%) 98 (18.8%)
Caesarean section 3 (1.5%) 3 (1.7%) 3 (1.7%) 1 (0.7%) 44 (8.5%)
 No 1 (0.2%)
 One 174 (88.8%) 93 (55%) 134(88%) 120 (58.7%) 7 (1.3%)
 Two 21 (10.7%) 61 (36.1%) 16 (10.4%) 63 (31.0%)
1 (0.5%) 15 (8.9%)) 1 (0.9%) 21 (10.3%) 376 (72.3%)
116 (22.3%)
28 (5.4%)

13

Laparoscopic In-Bag Morcellation 75

Discussion As seen, the technique of contained morcellation proves
to be acceptable, safe and can be mastered by gynaecolo-
Thousands of women have benefited from minimally inva- gists globally.
sive laparoscopic surgery in many countries. Few cases of
accidental leiomyosarcoma should not be the reason for All the parameters are comparable with safety. Laparo-
patients of fibroids who are at low risk of leiomyosarcoma scopic morcellation can be made acceptable in contained
to not have access to the benefits of minimal access surgery. fashion.

Issue of laparoscopic morcellation has been put under Laparoscopic radical hysterectomy with node dissection
caution and warning without giving adequate opportunity is accepted [7] wherein tissue may be positive for cancer
to find a solution. There is no debate that even one case cells. MRI-guided focused ultrasound is accepted [8] as a
of accidental leiomyosarcoma morcellated could increase treatment modality for fibroids without ruling out the pos-
the spread of tumour affecting patient safety in terms of sibility of leiomyosarcoma; similarly uterine artery emboli-
morbidity and post-operative lifespan, but it is not the same zation is also accepted.
for myoma. There is a myth that morcellation shortens the
lifespan, but it is applicable for leiomyosarcoma and has no Few study designs have focused on uterine cancers
relevance for myomas. including accidental cancer in hysterectomy, myomectomy,
uterine prolapse other than just myoma removal or hyster-
Considering the high incidence of fibroids irrespective ectomy for myoma uterus, wherein leiomyosarcoma is a
of the age of the woman and the number of laparoscopic surprise finding. These falsely exaggerate the possibility of
myomectomies done globally huge benefit of minimal access leiomyosarcoma incidence, which were actually other uter-
surgery is imparted to women, reported cases of leiomyosar- ine cancers too. These other uterine cancers can be picked
coma [6] have been statistically insignificant. No definitive up by Pap smear, ultrasonography, Color Doppler, curettage,
methods of diagnosing leiomyosarcoma are currently avail- aspiration cytology or hysteroscopy. The data are highly
able. In the given situation, young women in reproductive biased and of poor quality [9]. Our study is focused only
age group needing myomectomy and also elderly women on presumed myoma with accidental finding of leiomyo-
needing hysterectomy for large fibroids will be deprived of sarcoma, which is specific and there were no documented
MIS and will be forced to do open surgery which has more leiomyosarcoma in the 720 cases included.
morbidity, hospital stay and expenses.
A meta-analysis reveals that the rate of leiomyosarcoma
The steps of both methods of myomectomy—open or was 1 in 2000, restricting to the 64 studies; projected inci-
laparoscopic, are same, viz. injecting diluted vasopressin, dence of leiomyosarcoma was 1 in 8300 [9].
dissection of fibroids. Further dissected fibroids that are
separated, come in contact with surrounding structures. One Austrian multi-institutional study by Mayerhofer
Even during closure if we are closing the sarcoma or can- et al. [10] of 71 cases of leiomyosarcoma revealed that none
cerous bed with needle and suture which touches all tis- developed from a confirmed myoma. Thus, leiomyosarcoma
sues, it can spread myoma, sarcomatous or malignant cells. is primarily a separate tumour thought to be arising from
In both, there can be residual leiomyosarcoma which has myoma, which is a myth.
already spread in blood. This pre-existent spread cannot be
prevented. Genetic differences between fibroids and leiomyosarco-
mas indicate that leiomyosarcomas do not result from the
Widening the belly button or colpotomy or vaginal mor- malignant degeneration of fibroids. Cluster analysis of 146
cellation of large specimen can spread sarcoma or malig- genes found that the majority of genes are down-regulated in
nancy as the tissue and blood touch healthy tissues or peri- leiomyosarcomas but not in fibroids or myometrium. Com-
toneal cavity. parative genomic hybridization did not find specific anoma-
lies shared by fibroids and leiomyosarcomas [11].
The whole blame of spread of cancerous cells is put on
laparoscopic morcellation mainly due to spinning effect of Pritts et al. [12] found that, out of 2582 unsuspicious lapa-
tissues morcellated, which can spread sarcoma or even lead roscopic myomectomies, there was no case of leiomyosar-
to leiomyomatosis. coma, but 7 cases of atypical myomas were found in 1216
subjects, aged 18–45 years. Prevalence of leiomyosarcoma
With all these issues, our study involved obtaining an was 0% and atypical myoma was 0.6%.
acceptable technique. Laparoscopic contained morcellation
in 365 cases of fibroid or large uterus with fibroids over In a prospective study on peritoneal washings before
3 years was compared to a similar group of patients with and after morcellation [13], 21 patients had laparoscopic
conventional electromechanical morcellation done in 355 myomectomy; washings were collected 3 times, first on pri-
cases over 3 years earlier. mary vision, second after removal of myoma and closure and
third after uncontained power morcellation.

13

76 Trivedi et al.

Cell block histology detected spindle cells in 6 post- One cannot club all uterine cancers in the same group
morcellation samples; 3 had spindle cells detected on the to prevent morcellation of myoma proved to be non-can-
post-myomectomy closure samples. cerous. The error of some to morcellate uterus harbouring
cancer or leiomyosarcoma has nothing to do with morcel-
In 6 of 7 cases (85.7%) cases of in bag morcellation sys- lation of myoma proved to be non-cancerous by all avail-
tem used during laparoscopic hysterectomy [14], surgery able current modalities.
was successful, and morcellated specimens ranged from
205 g to 638 g (median 413). Average time associated to Further, our study also questions that how MRI-guided
bag use was 16.2 ± 7.65 min (median 14 min). Spread of focused ultrasound and uterine artery embolization are
spindle cells were detected in two cases after uncontained accepted by US FDA as treatment modalities even without
morcellation, but not after in-bag morcellation. tissue diagnosis. Even laparoscopic surgery for uterine and
early cervical cancers can be accepted even though we are
In one of our study of 21 cases of laparoscopic in-bag [4] dissecting tissues with possible malignant cells.
morcellation of fibroid and uterus (14 hysterectomy speci-
mens with maximum weight of 1.4 kg and 7 myomectomy In our study, no case of leiomyosarcoma was found in
specimens with fibroids ranging from 4 to 7 cm in size) the patients with myomas. Contained electromechanical mor-
technique was safe and useful. cellation for myomas or uterus with myomas is acceptable.

Conclusion The authors strongly believe and request all major
gynaecological endoscopy organizations of the world,
With the US FDA restriction on laparoscopic morcellation focused on women’s health to rise up to the expectation of
in 2014, there is a concern especially for morcellation of protecting women’s right for minimal access surgery for
myoma or uterus with myomas globally in high-volume myomas, as they deserve.
advanced laparoscopic surgery units.
Compliance with Ethical Standards
Total Health Care Centre in India did a comparative
study over 6 years, evaluating acceptability of laparo- Conflict of interest We, the authors, Prakash H. Trivedi, Soumil Trive-
scopic contained morcellation (365 cases) versus laparo- di and Sandeep Patil, state that there is no conflict of interest or any
scopic conventional morcellation (355 cases) in women financial disclosures.
presumed to have myomas or uterus with myomas from
13 May 2012 to 14 August 2018. Ethical Approval All procedures followed were in accordance with the
ethical standards of the responsible committee, and informed consent
In cases of Laparaoscopic myomectomy, conventional was obtained from all patients for being included in the study.
or in bag contained morcellation operating time and blood
loss was comparable. However, in Laparoscopic Hysterec- Human and Animals Rights This article does not contain any studies
tomy for large fibroids, in bag morcellation had less oper- with animal subjects.
ating time which was statistically significant. There was
no case of Leiomyosarcoma or mortality in either group. References

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2. Food and Drug Administration. FDA discourages use of Lapa-
Whether a myoma develops or transforms to leiomyo- roscopic power morcellation for removal of uterus or uterine
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