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. 2020 Jul 1;7(7):CD013663.
doi: 10.1002/14651858.CD013663.

Mechanical and surgical interventions for treating primary postpartum haemorrhage

Affiliations

Mechanical and surgical interventions for treating primary postpartum haemorrhage

Frances J Kellie et al. Cochrane Database Syst Rev. .

Abstract

Background: Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common causes of maternal mortality worldwide and causes significant physical and psychological morbidity. An earlier Cochrane Review considering any treatments for the management of primary PPH, has been split into separate reviews. This review considers treatment with mechanical and surgical interventions.

Objectives: To determine the effectiveness and safety of mechanical and surgical interventions used for the treatment of primary PPH.

Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 July 2019) and reference lists of retrieved studies.

Selection criteria: Randomised controlled trials (RCTs) of mechanical/surgical methods for the treatment of primary PPH compared with standard care or another mechanical/surgical method. Interventions could include uterine packing, intrauterine balloon insertion, artery ligation/embolism, or uterine compression (either with sutures or manually). We included studies reported in abstract form if there was sufficient information to permit risk of bias assessment. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not.

Data collection and analysis: Two review authors independently assessed studies for inclusion and risk of bias, independently extracted data and checked data for accuracy. We used GRADE to assess the certainty of the evidence.

Main results: We included nine small trials (944 women) conducted in Pakistan, Turkey, Thailand, Egypt (four trials), Saudi Arabia, Benin and Mali. Overall, included trials were at an unclear risk of bias. Due to substantial differences between the studies, it was not possible to combine any trials in meta-analysis. Many of this review's important outcomes were not reported. GRADE assessments ranged from very low to low, with the majority of outcome results rated as very low certainty. Downgrading decisions were mainly based on study design limitations and imprecision; one study was also downgraded for indirectness. External uterine compression versus normal care (1 trial, 64 women) Very low-certainty evidence means that we are unclear about the effect on blood transfusion (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.66 to 8.23). Uterine arterial embolisation versus surgical devascularisation plus B-Lynch (1 trial, 23 women) The available evidence for hysterectomy to control bleeding (RR 0.73, 95% CI 0.15 to 3.57) is unclear due to very low-certainty evidence. The available evidence for intervention side effects is also unclear because the evidence was very low certainty (RR 1.09; 95% CI 0.08 to 15.41). Intrauterine Tamponade Studies included various methods of intrauterine tamponade: the commercial Bakri balloon, a fluid-filled condom-loaded latex catheter ('condom catheter'), an air-filled latex balloon-loaded catheter ('latex balloon catheter'), or traditional packing with gauze. Balloon tamponade versus normal care (2 trials, 356 women) One study(116 women) used the condom catheter. This study found that it may increase blood loss of 1000 mL or more (RR 1.52, 95% CI 1.15 to 2.00; 113 women), very low-certainty evidence. For other outcomes the results are unclear and graded as very low-certainty evidence: mortality due to bleeding (RR 6.21, 95% CI 0.77 to 49.98); hysterectomy to control bleeding (RR 4.14, 95% CI 0.48 to 35.93); total blood transfusion (RR 1.49, 95% CI 0.88 to 2.51); and side effects. A second study of 240 women used the latex balloon catheter together with cervical cerclage. Very low-certainty evidence means we are unclear about the effect on hysterectomy (RR 0.14, 95% CI 0.01 to 2.74) and additional surgical interventions to control bleeding (RR 0.20, 95% CI 0.01 to 4.12). Bakri balloon tamponade versus haemostatic square suturing of the uterus (1 trial, 13 women) In this small trial there was no mortality due to bleeding, serious maternal morbidity or side effects of the intervention, and the results are unclear for blood transfusion (RR 0.57, 95% CI 0.14 to 2.36; very low certainty). Bakri balloon tamponade may reduce mean 'intraoperative' blood loss (mean difference (MD) -426 mL, 95% CI -631.28 to -220.72), very low-certainty evidence. Comparison of intrauterine tamponade methods (3 trials, 328 women) One study (66 women) compared the Bakri balloon and the condom catheter, but it was uncertain whether the Bakri balloon reduces the risk of hysterectomy to control bleeding due to very low-certainty evidence (RR 0.50, 95% CI 0.05 to 5.25). Very low-certainty evidence also means we are unclear about the results for the risk of blood transfusion (RR 0.97, 95% CI 0.88 to 1.06). A second study (50 women) compared Bakri balloon, with and without a traction stitch. Very low-certainty evidence means we are unclear about the results for hysterectomy to control bleeding (RR 0.20, 95% CI 0.01 to 3.97). A third study (212 women) compared the condom catheter to gauze packing and found that it may reduce fever (RR 0.47, 95% CI 0.38 to 0.59), but again the evidence was very low certainty. Modified B-Lynch compression suture versus standard B-Lynch compression suture (1 trial, 160 women) Low-certainty evidence suggests that a modified B-Lynch compression suture may reduce the risk of hysterectomy to control bleeding (RR 0.33, 95% CI 0.11 to 0.99) and postoperative blood loss (MD -244.00 mL, 95% CI -295.25 to -192.75).

Authors' conclusions: There is currently insufficient evidence from RCTs to determine the relative effectiveness and safety of mechanical and surgical interventions for treating primary PPH. High-quality randomised trials are urgently needed, and new emergency consent pathways should facilitate recruitment. The finding that intrauterine tamponade may increase total blood loss > 1000 mL suggests that introducing condom-balloon tamponade into low-resource settings on its own without multi-system quality improvement does not reduce PPH deaths or morbidity. The suggestion that modified B-Lynch suture may be superior to the original requires further research before the revised technique is adopted. In high-resource settings, uterine artery embolisation has become popular as the equipment and skills become more widely available. However, there is little randomised trial evidence regarding efficacy and this requires further research. We urge new trial authors to adopt PPH core outcomes to facilitate consistency between primary studies and subsequent meta-analysis.

Trial registration: ClinicalTrials.gov NCT02430155 NCT02910310 NCT02660567 NCT03570723 NCT01980173 NCT02416089 NCT02568657 NCT02694341 NCT02735733 NCT03891082 NCT02226731.

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Conflict of interest statement

JW: has received FIGO/Wellbeing fellowship. This was a training fellowship and included facilitation of this review. The award also supported travel and attendance at training workshops in systematic review methodologies in Liverpool and at other UK institutions.

ADW: has been involved in misoprostol research for many years and runs www.misoprostol.org, which is a website that seeks to provide independent information on misoprostol doses. He has been an investigator on a team investigating the use of misoprostol for postpartum haemorrhage prophylaxis in rural Uganda. He is also one of two inventors of the PPH Butterfly ‐ a device to facilitate bimanual compression of the uterus. The patent is held by his employer (the University of Liverpool), but ADW would receive royalties from any future sales of the device.

HM: none known.

FK: is the Managing Editor of Cochrane Pregnancy and Childbirth and employed by the University of Liverpool via NIHR Cochrane Infrastructure funding paid to the host institution. Cochrane Pregnancy and Childbirth also received project funding from WHO to prepare Cochrane evidence to inform prioritised WHO recommendations for updating. FK is a member of the Executive Guideline Steering Group for Updating WHO Maternal and Perinatal Health Recommendations (2017 to 2019) and she has received travel and per diem expenses from WHO within the last three years in relation to attendance at WHO technical and prioritisation meetings. As a member of Cochrane Pregnancy and Childbirth's editorial team, Frances has not been involved in the editorial processing or any editorial decisions relating to the protocol, or the subsequent review.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1: External lower uterine compression versus normal care, Outcome 1: Blood transfusion (red cell or whole blood)
1.2
1.2. Analysis
Comparison 1: External lower uterine compression versus normal care, Outcome 2: Post‐randomisation additional uterotonic agent used to control bleeding
2.1
2.1. Analysis
Comparison 2: Uterine arterial embolisation versus surgical devascularisation plus B‐Lynch (one uterine devascularisation technique versus another uterine devascularisation technique), Outcome 1: Hysterectomy to control bleeding
2.2
2.2. Analysis
Comparison 2: Uterine arterial embolisation versus surgical devascularisation plus B‐Lynch (one uterine devascularisation technique versus another uterine devascularisation technique), Outcome 2: Side effects of the intervention (e.g. trauma, necrosis)
3.1
3.1. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 1: Mortality due to bleeding
3.2
3.2. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 2: Hysterectomy to control bleeding
3.3
3.3. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 3: All cause mortality
3.4
3.4. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 4: Mortality from causes other than bleeding
3.5
3.5. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 5: Number of women with total blood loss 1000 mL or more after randomisation
3.6
3.6. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 6: Blood transfusion (red cell or whole blood)
3.7
3.7. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 7: Post‐randomisation additional surgical interventions used to control bleeding (arterial ligation, compressive, uterine sutures, arterial embolisation, laparotomy)
3.8
3.8. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 8: Admission to higher level of care
3.9
3.9. Analysis
Comparison 3: Intrauterine balloon tamponade plus normal care (misoprostol) versus normal care (misoprostol), Outcome 9: Side effects of the intervention (e.g. trauma, necrosis)
4.1
4.1. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 1: Mortality due to bleeding
4.2
4.2. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 2: Hysterectomy to control bleeding
4.3
4.3. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 3: All‐case mortality
4.4
4.4. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 4: Mortality from causes other than bleeding
4.5
4.5. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 5: Days in hospital
4.6
4.6. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 6: Post‐randomisation additional surgical interventions used to control bleeding
4.7
4.7. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 7: Post‐randomisation additional non‐surgical interventions used to control bleeding
4.8
4.8. Analysis
Comparison 4: Latex balloon (air filled) tamponade + stitch and normal care versus normal care (Intrauterine tamponade versus normal care), Outcome 8: Side effects of the intervention (e.g. trauma, necrosis)
5.1
5.1. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 1: Mortality due to bleeding
5.2
5.2. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 2: Hysterectomy to control bleeding
5.3
5.3. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 3: Serious maternal morbidity (renal or respiratory failure, cardiac arrest or multiple organ failure)
5.4
5.4. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 4: All cause mortality
5.5
5.5. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 5: Mortality from causes other than bleeding
5.6
5.6. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 6: Mean blood loss (mL) (trialist defined)
5.7
5.7. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 7: Blood transfusion (red cell or whole blood)
5.8
5.8. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 8: Post‐randomisation additional surgical interventions used to control bleeding (arterial ligation, compressive, uterine sutures, arterial embolisation, laparotomy)
5.9
5.9. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 9: Side effects of the intervention (e.g. trauma, necrosis)
5.10
5.10. Analysis
Comparison 5: Bakri balloon tamponade versus haemostatic square suturing to the lower segment of the uterus (Intrauterine tamponade versus another mechanical/surgical method), Outcome 10: Postnatal blood loss (not pre‐specified)
6.1
6.1. Analysis
Comparison 6: Bakri balloon tamponade versus condom‐loaded Foley catheter (one intrauterine tamponade technique versus another intrauterine tamponade technique), Outcome 1: Hysterectomy to control bleeding
6.2
6.2. Analysis
Comparison 6: Bakri balloon tamponade versus condom‐loaded Foley catheter (one intrauterine tamponade technique versus another intrauterine tamponade technique), Outcome 2: Coagulopathy as defined by trialist
6.3
6.3. Analysis
Comparison 6: Bakri balloon tamponade versus condom‐loaded Foley catheter (one intrauterine tamponade technique versus another intrauterine tamponade technique), Outcome 3: Blood transfusion (red cell or whole blood)
6.4
6.4. Analysis
Comparison 6: Bakri balloon tamponade versus condom‐loaded Foley catheter (one intrauterine tamponade technique versus another intrauterine tamponade technique), Outcome 4: Post‐randomisation additional surgical interventions used to control bleeding (arterial ligation, compressive, uterine sutures, arterial embolisation, laparotomy)
6.5
6.5. Analysis
Comparison 6: Bakri balloon tamponade versus condom‐loaded Foley catheter (one intrauterine tamponade technique versus another intrauterine tamponade technique), Outcome 5: Admission to higher level of care
6.6
6.6. Analysis
Comparison 6: Bakri balloon tamponade versus condom‐loaded Foley catheter (one intrauterine tamponade technique versus another intrauterine tamponade technique), Outcome 6: Side effects of the intervention
7.1
7.1. Analysis
Comparison 7: Bakri balloon + stitch versus Bakri balloon without stitch (one intrauterine tamponade versus another intrauterine tamponade technique), Outcome 1: Hysterectomy to control bleeding
7.2
7.2. Analysis
Comparison 7: Bakri balloon + stitch versus Bakri balloon without stitch (one intrauterine tamponade versus another intrauterine tamponade technique), Outcome 2: Post‐randomisation additional surgical interventions used to control bleeding (arterial ligation, compressive, uterine sutures, arterial embolisation, laparotomy)
7.3
7.3. Analysis
Comparison 7: Bakri balloon + stitch versus Bakri balloon without stitch (one intrauterine tamponade versus another intrauterine tamponade technique), Outcome 3: Total blood loss >= 1000 mL (before and after randomisation, not pre‐specified)
8.1
8.1. Analysis
Comparison 8: Intrauterine balloon tamponade (condom catheter) versus uterovaginal packing (Intrauterine tamponade versus another mechanical/surgical method), Outcome 1: Side effects of the intervention
9.1
9.1. Analysis
Comparison 9: Modified B‐Lynch compression suture versus standard B‐Lynch compression suture (one uterine compression suture technique versus another uterine compression suture technique), Outcome 1: Hysterectomy to control bleeding
9.2
9.2. Analysis
Comparison 9: Modified B‐Lynch compression suture versus standard B‐Lynch compression suture (one uterine compression suture technique versus another uterine compression suture technique), Outcome 2: Mean blood loss (mL) (trialist defined)
9.3
9.3. Analysis
Comparison 9: Modified B‐Lynch compression suture versus standard B‐Lynch compression suture (one uterine compression suture technique versus another uterine compression suture technique), Outcome 3: Days in hospital

References

References to studies included in this review

Ashraf 2018 {published data only}
    1. Ashraf N, Ashraf A, Khursheed K. Efficacy and safety of intrauterine balloon tamponade versus ueterovaginal roll gauze packing in patient presenting with primary postpartum haemorrhage after normal vaginal delivery. Annals of King Edward Medical University 2018;24(Special Issue):889-92.
Chantrapitak 2009 {published data only}
    1. Chantrapitak W, Srijanteok K, Puangsa-art S. Lower uterine segment compression for management of early postpartum hemorrhage after vaginal delivery at Charoenkrung Pracharak Hospital. Journal of the Medical Association of Thailand 2009;92(5):600-5. [PMID: ] - PubMed
Darwish 2018 {published data only}
    1. Darwish AM, Abdallah MM, Shaaban OM, Ali MK, Khalaf M, Sabra AM. Bakri balloon versus condom-loaded foley's catheter for treatment of atonic postpartum hemorrhage secondary to vaginal delivery: a randomized controlled trial. Journal of Maternal-Fetal & Neonatal Medicine 2018;31(6):747-53. - PubMed
    1. NCT02430155. Comparison of condom-loaded foley's catheter versus bakri balloon for treatment of primary postpartum hemorrhage: a randomized controlled trial. clinicaltrials.gov/show/NCT02430155 (first received 30 April 2015).
Dumont 2017 {published data only}ISRCTN01202389
    1. Dumont A, Bodin C, Hounkpatin B, Popowski T, Traore M, Perrin R, et al. Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in benin and mali. BMJ Open 2017;7(9):e016590. - PMC - PubMed
    1. ISRCTN01202389. Evaluation of intrauterine balloon tamponade efficacy with condom catheter and misoprostol (usual treatment) compared to misoprostol alone in the severe postpartum management hemorrhage management in Benin and Mali: a randomized controlled trial. www.isrctn.com/ISRCTN01202389 (first received 9 September 2013).
    1. Tort J, Hounkpatin B, Popowski T, Traore M, Bodin C, Perrin R, et al. A randomized controlled trial to test the effectiveness of intrauterine balloon tamponade with condom catheter in severe postpartum hemorrhage management: a feasibility study in Benin. Journal of Women's Health Care 2013;2(4):135.
El‐Sokkary 2016 {published data only}
    1. El-Sokkary M, Wahba K, El-Shahawy Y. Uterine salvage management for atonic postpartum hemorrhage using "modified lynch suture". BMC Pregnancy and Childbirth 2016;16:251. - PMC - PubMed
Farouk 2016 {published data only}
    1. Farouk O, Elbasuony W, Elbohouty A. Uterine artery embolization versus surgical management in primary atonic postpartum hemorrhage: A randomized clinical trial. Egyptian Journal of Radiology and Nuclear Medicine 2016;47(3):817-23.
Kavak 2013 {published data only}
    1. Kavak SB, Atilgan R, Demirel I, Celik E, Ilhan R, Sapmaz E. Endouterine hemostatic square suture vs. Bakri balloon tamponade for intractable hemorrhage due to complete placenta previa. Journal of Perinatal Medicine 2013;41(6):705-9. - PubMed
Khalil 2011 {published data only}
    1. Khalil MI, Al-Dohami H, Aldahish MM. A method to improve the effectiveness of the Bakri balloon for management of postpartum hemorrhage at cesarean. International Journal of Gynecology & Obstetrics 2011;115(2):198-200. - PubMed
Soltan 2007 {published data only}
    1. Soltan MH, Mohamed A, Ibrahim E, Gohar A, Ragab H. El-Menia air inflated balloon in controlling atonic post partum hemorrhage. International Journal of Health Sciences, Qassim University 2007;1(1):53-9. - PMC - PubMed

References to studies excluded from this review

Anger 2016 {published data only}
    1. NCT02910310. Introduction of a uterine balloon tamponade for postpartum hemorrhage in three low income countries: a stepped wedge cluster randomized trial. clinicaltrials.gov/show/NCT02910310 (first received 22 September 2016).
Azmy 2016 {published data only}
    1. NCT02660567. The impacts of using amr's maneuver (cervical traction) on atonic postpartum hemorrhage; multi-centre randomized controlled study. clinicaltrials.gov/show/NCT02660567 (first received 21 January 2016).
Chen 2017 {published data only}
    1. ChiCTR-IOR-17012244. Bilateral internal iliac artery balloon occlusion for the management of pernicious placenta previa and accreta. www.chictr.org.cn/showproj.aspx?proj=20741 (first received 4 August 2017).
Farouk 2018 {published data only}
    1. Farouk H, NCT03570723. Glove-loaded foley's catheter tamponade to reducing blood loss during cesarean delivery for complete placenta previa: a randomized controlled trial. clinicaltrials.gov/ct2/show/NCT03570723 (first received 27 June 2018).
Gelany 2012 {published data only}
    1. Gelany SA, Soltan MH. External aortic compression device, manual aortic compression & El Minya air inflated balloon: simple, cost-effective, and saving many lives in low resource settings. International Journal of Gynaecology and Obstetrics 2012;119:S335.
Khalil 2014 {published data only}
    1. Khalil M. Upper segment caesarean section, bilateral uterine artery ligation, with Khalil, s traction stitch for Bakri balloon tamponade to control postpartum hemorrhage from morbid adherent placenta previa. Journal of Maternal-Fetal & Neonatal Medicine 2014;27(Suppl 1):40.
Letouzey 2013 {published data only}
    1. Letouzey V, NCT01980173. Medico-economic comparison of postpartum hemorrhage management using the bakri balloon and standard care. https://clinicaltrials.gov/show/NCT01980173 (first received 8 Novemmber 2013).
Liu 2016 {published data only}
    1. Liu M, Li D. Effect of overall care for postpartum major hemorrhage patients with uterine artery embolization. Chinese Journal of Interventional Imaging and Therapy 2016;13(6):338-41.
Mohamed 2014 {published data only}
    1. Mohamed AM, Agawany AS, Abd Rabbo S. Stepwise devascularization versus B-Lynch for massive postpartum haemorrhage. BJOG: an international journal of obstetrics and gynaecology 2014;121(Suppl 2):120.
Nermeen 2015 {published data only}
    1. Nermeen SE, Aly K, Sameh SE, Amr AE. Uterine compression sutures and the amount of post partum blood loss in high risk cases of atonic post partum hemorrhage. Journal of Perinatal Medicine 2015;43(Suppl 1):Abstract no: O-0006.
Purwosonu 2015 {published data only}
    1. Purwosonu Y, Widyastuti. Control of post-partum hemorrhage by vacuum induced uterine tamponade. Journal of Obstetrics and Gynaecology Research 2015;41(Suppl S1):47, Abstract no: FC 9.01.
Rahman 2015 {published data only}
    1. NCT02416089. Tampostat: a low-cost, self-regulating tamponade for management of postpartum hemorrhage in Bangladesh. clinicaltrials.gov/show/NCT02416089 (first received 14 April 2015).
Rezk 2016 {published data only}
    1. PACTR201610001803327. Bilateral uterine artery ligation and square sutures versus a novel combined suture for controlling bleeding from the placental bed in placenta previa centralis at cesarean section: a randomized clinical trial. pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201610... (first received 3 October 2016).
Sallam 2019 {published data only}
    1. Sallam HF, Shady NW. A sandwich technique (N&H variation technique) to reduce blood loss during cesarean delivery for complete placenta previa: a randomized controlled trial. Journal of Maternal-Fetal & Neonatal Medicine 2019;32(19):3145-152. - PubMed
Soltan 2009 {published data only}
    1. Soltan MH, Faragallah MF, Mosabah MH, Al-Adawy AR. External aortic compression device: the first aid for postpartum hemorrhage control. Journal of Obstetrics and Gynaecology Research 2009;35(3):453-8. - PubMed
Soltan 2010 {published data only}
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von Beckerath 2016 {published data only}
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References to studies awaiting assessment

Ali 2015 {published data only}
    1. NCT02568657. Comparison between celox versus bakri balloon for treatment of primary atonic postpartum hemorrhage. clinicaltrials.gov/ct2/show/record/NCT02568657 (first received 6 October 2015).
Elkateeb 2016 {published data only}
    1. Elkateeb R, PACTR201601001435165. Using of bakri balloon cathter with intrauterine washing with misoprostol in cases of atonic postpartum hemorrhage. pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201601... (first received 23 January 2016).

References to ongoing studies

Abbas 2016 {published data only}
    1. Abbas MA, NCT02694341. Bakri balloon with or without abdominal traction stitch in management of uterine bleeding in cases of placenta previa. clinicaltrials.gov/ct2/show/NCT02694341 (first received 29 February 2016).
Hofmeyr 2019 {published data only}
    1. Hofmeyr GJ, PACTR201907769424884. Uterine vacuum tamponade for treatment of postpartum haemorrhage: a randomized study. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8223 (first received 30 June 2019).
Hu 2015 {published data only}
    1. ChiCTR-ICR-15006467. The comparative study to evaluate the success rate of the intrauterine tamponade balloon and gauze packing the event of uncontrollable hemorrhage due to placenta previa in cesarean section cases: a randomized perspective controlled multicenter trial. chictr.org.cn/showproj.aspx?proj=11074 (first received 29 June 2015).
Joshipura 2016 {published data only}
    1. NCT02735733. Does cold saline used to inflate a balloon tamponade catheter more significantly reduce blood loss from postpartum hemorrhage than room temperature saline? clinicaltrials.gov/ct2/show/record/NCT02735733 (first received 16 April 2016).
Maged 2019 {published data only}
    1. Maged A, NCT03891082. A comparative study between Bakri Balloon and B lynch suture used to control primary postpartum hemorrhage after cesarean section. https://clinicaltrials.gov/ct2/show/NCT03891082 (first received 26 March 2019).
Rozenberg 2014 {published data only}
    1. NCT02226731. Assessment of the efficacy of early intrauterine tamponade with a belfort-dildy balloon obstetric tamponade system in the treatment of immediate postpartum hemorrhage. clinicaltrials.gov/show/NCT02226731 (first received 27 August 2014).

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Aisaka 1988
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References to other published versions of this review

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