Randomized Controlled Trial

. 2025 Jul;170(1):326-337.

doi: 10.1002/ijgo.16164. Epub 2025 Jan 24.

Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial

Mandisa Singata-Madliki¹, Albaro J Nieto-Calvache², Luisa F Rivera Torres³, Hazmath Abdul⁴, Joanne Batting¹, Sylvia N Cebekhulu⁵, Lawrence Chauke⁶, Priya Soma-Pillay⁷, Susan Fawcus⁸, Logie Govender⁴, Busiwe Majeke⁹, Xolani Mbongozi¹⁰, Katrin Middleton¹¹, Poovangela Naidoo¹², Sanele Ndaba¹³, Trevi Spence¹⁴, Gaynor M Balie⁶, Angelica Monroy², Monica Cantor², G Justus Hofmeyr^{1

15}

Affiliations

¹ Effective Care Research Unit, University of the Witwatersrand and Walter Sisulu University, East London, South Africa.
² Unidad De Alta Complejidad Obstetrica, Fundación Valle Del Lili, Cali, Colombia.
³ Centro De Investigaciones Clínicas, Fundación Valle Del Lili, Cali, Colombia.
⁴ Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University Of Kwazulu-Natal, KwaZulu-Natal, South Africa.
⁵ Department of Obstetrics and Gynaecology, Bongani Regional Hospital, University of the Free State, Department of Health, Bloemfontein, South Africa.
⁶ Department of Obstetrics and Gynaecology, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa.
⁷ Department of Obstetrics and Gynaecology, Steve Biko Academic Hospital, University of Pretoria, UP/SAMRC Research Centre for Maternal, Fetal, Newborn and Child Healthcare Strategies, Pretoria, South Africa.
⁸ Department Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
⁹ Department of Obstetrics and Gynaecology at Cecilia Makiwane Hospital, And Walter Sisulu University, East London, South Africa.
¹⁰ Department of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa.
¹¹ Department of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa.
¹² Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.
¹³ Department of Obstetrics and Gynaecology, Kalafong Hospital, University of Pretoria, Pretoria, South Africa.
¹⁴ Department of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa.
¹⁵ University of Botswana, Gaborone, Botswana.

PMID: 39853765
PMCID: PMC12177279
DOI: 10.1002/ijgo.16164

Randomized Controlled Trial

Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial

Mandisa Singata-Madliki et al. Int J Gynaecol Obstet. 2025 Jul.

. 2025 Jul;170(1):326-337.

doi: 10.1002/ijgo.16164. Epub 2025 Jan 24.

Authors

Affiliations

¹ Effective Care Research Unit, University of the Witwatersrand and Walter Sisulu University, East London, South Africa.
² Unidad De Alta Complejidad Obstetrica, Fundación Valle Del Lili, Cali, Colombia.
³ Centro De Investigaciones Clínicas, Fundación Valle Del Lili, Cali, Colombia.
⁴ Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University Of Kwazulu-Natal, KwaZulu-Natal, South Africa.
⁵ Department of Obstetrics and Gynaecology, Bongani Regional Hospital, University of the Free State, Department of Health, Bloemfontein, South Africa.
⁶ Department of Obstetrics and Gynaecology, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa.
⁷ Department of Obstetrics and Gynaecology, Steve Biko Academic Hospital, University of Pretoria, UP/SAMRC Research Centre for Maternal, Fetal, Newborn and Child Healthcare Strategies, Pretoria, South Africa.
⁸ Department Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
⁹ Department of Obstetrics and Gynaecology at Cecilia Makiwane Hospital, And Walter Sisulu University, East London, South Africa.
¹⁰ Department of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa.
¹¹ Department of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa.
¹² Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.
¹³ Department of Obstetrics and Gynaecology, Kalafong Hospital, University of Pretoria, Pretoria, South Africa.
¹⁴ Department of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa.
¹⁵ University of Botswana, Gaborone, Botswana.

PMID: 39853765
PMCID: PMC12177279
DOI: 10.1002/ijgo.16164

Abstract

Objective: To compare low-cost "Suction Tube Uterine Tamponade" (STUT) treatment for refractory postpartum hemorrhage (PPH) with uterine balloon tamponade (UBT) using a randomized feasibility study.

Methods: After verbal assent, we allocated participants with refractory PPH by randomly ordered envelopes to STUT or routine UBT at 10 hospitals in South Africa and one tertiary referral center in Colombia between January 10, 2020, and May 3, 2024. In the STUT group, we inserted a 24 FG Levin stomach tube into the uterine cavity and applied suction. The control group received standard UBT, mainly the Elavi free-flow balloon or the Bakri fixed volume balloon. There were fundamental differences between the South African and the Colombian sites, so the pre-specified analysis combined data from the two countries by meta-analysis.

Results: We enrolled 59 participants. The rate of the primary outcome (blood loss >1000 mL or laparotomy or death) was 8/27 (30%) in the STUT group versus 14/27 (52%) in the UBT group (risk ratio [RR] 0.56, 95% confidence interval [CI] 0.30-1.05, P = 0.07). Per protocol analysis was 7/26 (27%) versus 15/28 (54%) (RR 0.49, 95% CI 0.25-0.96, P = 0.04). Reporting severe pain during the procedures was less frequent in the STUT group (RR 0.46, 95% CI 0.25-0.86, P = 0.01). Most secondary outcomes favored the STUT group, with low certainty.

Conclusions: STUT was experienced as less painful than UBT. Results were consistent with reported observational findings and one other randomized trial evidence of greater effectiveness for suction than balloon tamponade.

Keywords: feasibility; postpartum hemorrhage; randomized clinical trial; suction tube uterine tamponade; uterine balloon tamponade.

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Conflict of interest statement

GJH has received consultancies as inventor of the Maternawell calibrated tray for blood loss monitoring after birth, which was not used in this study. The other authors have no conflicts of interest.

Figures

**FIGURE 1**
CONSORT flow diagram. Numbers are given for South Africa + Colombia respectively. STUT, suction tube uterine tamponade; UBT, uterine balloon tamponade. * In South Africa, potential participants who were not randomized were not recorded.

**FIGURE 2**
Forrest plot of meta‐analysis of data from Colombia and South Africa (current study) and recent India trial for the primary outcome blood loss greater than 1000 mL (Mantel‐Heinzel method, fixed effects).

See this image and copyright information in PMC

References

1. Gallos I, Devall A, Martin J, et al. Randomized trial of early detection and treatment of postpartum hemorrhage. N Engl J Med. 2023;389(1):11‐21. - PubMed
1. Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020;1(7):CD013663. doi: 10.1002/14651858.CD013663 PMID: 32609374. - DOI - PMC - PubMed
1. https://apps.who.int/iris/bitstream/handle/10665/340796/9789240013841‐en....
1. Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P, Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study, BJOG 2017;124(8):1255–1262 - PubMed
1. Finlayson K, Vogel JP, Althabe F, Widmer M, Oladapo OT. Healthcare providers experiences of using uterine balloon tamponade (UBT) devices for the treatment of post‐partum haemorrhage: a meta‐synthesis of qualitative studies. PLoS One. 2021;16(3):e0248656. - PMC - PubMed

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Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial

Affiliations

Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources