Evidence map›Paper›PMID 39853765›Full record

Trial reportInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2025

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 and 10 more

Abstract readRandomized Controlled TrialComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Suction tube uterine tamponade versus uterine balloon tamponade for treatment of refractory postpartum hemorrhage: A randomized clinical feasibility trial.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Trial
  2. Achieving Equitable Access to Obstetric Devices Through Innovation, Improvisation and Off-Label Use.BJOG : an international journal of obstetrics and gynaecology · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Mandisa Singata-MadlikiEffective Care Research Unit, University of the Witwatersrand and Walter Sisulu University, East London, South Africa.ORCID https://orcid.org/0000-0003-4193-8786
Albaro J Nieto-CalvacheUnidad De Alta Complejidad Obstetrica, Fundación Valle Del Lili, Cali, Colombia.ORCID https://orcid.org/0000-0001-5639-9127
Luisa F Rivera TorresCentro De Investigaciones Clínicas, Fundación Valle Del Lili, Cali, Colombia.ORCID https://orcid.org/0009-0000-7980-8595
Hazmath AbdulDepartment of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University Of Kwazulu-Natal, KwaZulu-Natal, South Africa.
Joanne BattingEffective Care Research Unit, University of the Witwatersrand and Walter Sisulu University, East London, South Africa.
Sylvia N CebekhuluDepartment of Obstetrics and Gynaecology, Bongani Regional Hospital, University of the Free State, Department of Health, Bloemfontein, South Africa.ORCID https://orcid.org/0000-0001-6312-165X
Lawrence ChaukeDepartment 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.ORCID https://orcid.org/0000-0001-7051-6959
Priya Soma-PillayDepartment 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.
Susan FawcusDepartment Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
Logie GovenderDepartment of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University Of Kwazulu-Natal, KwaZulu-Natal, South Africa.ORCID https://orcid.org/0000-0001-8157-7116
Busiwe MajekeDepartment of Obstetrics and Gynaecology at Cecilia Makiwane Hospital, And Walter Sisulu University, East London, South Africa.
Xolani MbongoziDepartment of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa.ORCID https://orcid.org/0000-0001-6113-3091
Katrin MiddletonDepartment of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa.
Poovangela NaidooDepartment of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.ORCID https://orcid.org/0000-0003-1879-7137
Sanele NdabaDepartment of Obstetrics and Gynaecology, Kalafong Hospital, University of Pretoria, Pretoria, South Africa.ORCID https://orcid.org/0000-0001-9432-2198
Trevi SpenceDepartment of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa.
Gaynor M BalieDepartment 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.
Angelica MonroyUnidad De Alta Complejidad Obstetrica, Fundación Valle Del Lili, Cali, Colombia.ORCID https://orcid.org/0009-0006-7669-1807
Monica CantorUnidad De Alta Complejidad Obstetrica, Fundación Valle Del Lili, Cali, Colombia.
G Justus HofmeyrEffective Care Research Unit, University of the Witwatersrand and Walter Sisulu University, East London, South Africa.ORCID https://orcid.org/0000-0002-3080-1007

Funding

New Venture Fund NVF-NGDF-UNIV1-Subgrant-011970-2021-01-01
6 · The paper itself

Abstract

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

methodsAfter 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.

resultsWe 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.

conclusionsSTUT 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.

Indexed as

Postpartum HemorrhageUterine Balloon TamponadeAdultColombiaFeasibility StudiesFemaleHumansPregnancySouth AfricaSuctionTreatment Outcomefeasibilitypostpartum hemorrhagerandomized clinical trialsuction tube uterine tamponadeuterine balloon tamponade

Identifiers

PMID39853765
PMCPMC12177279

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.