International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Singata-Madliki Mandisa, Nieto-Calvache Albaro J, Rivera Torres Luisa F, Abdul Hazmath, Batting Joanne, Cebekhulu Sylvia N, Chauke Lawrence, Soma-Pillay Priya, Fawcus Susan, Govender Logie, Majeke Busiwe, Mbongozi Xolani, Middleton Katrin, Naidoo Poovangela, Ndaba Sanele, Spence Trevi, Balie Gaynor M, Monroy Angelica, Cantor Monica, Hofmeyr G Justus
Аннотация
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.
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.