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

Mandisa Singata-Madliki; Albaro J Nieto-Calvache; Luisa F Rivera Torres; Hazmath Abdul; Joanne Batting; Sylvia N Cebekhulu; Lawrence Chauke; Priya Soma-Pillay; Susan Fawcus; Logie Govender; Busiwe Majeke; Xolani Mbongozi; Katrin Middleton; Poovangela Naidoo; Sanele Ndaba; Trevi Spence; Gaynor M Balie; Angelica Monroy; Monica Cantor; G Justus Hofmeyr

doi:10.1002/ijgo.16164

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

Int J Gynaecol Obstet. 2025 Jan 24. doi: 10.1002/ijgo.16164. Online ahead of print.

Authors

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
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.

Grants and funding

NVF-NGDF-UNIV1-Subgrant-011970-2021-01-01/New Venture Fund