"Suction Tube Uterine Tamponade" for treatment of refractory postpartum hemorrhage: Internal feasibility and acceptability pilot of a randomized clinical trial

Sylvia N Cebekhulu; Hazmath Abdul; Joanne Batting; Lawrence Chauke; Fuziwe Dlakavu; Sue Fawcus; Logie Govender; Busiwe Majeke; Xolani Mbongozi; Mandisa Singata-Madliki; Katrin Middleton; Philiswa Mlandu; Poovangela Naidoo; Sanele Ndaba; Priya Soma-Pillay; Trevi Spence; Symphorien C Ntambua; Justus Hofmeyr

doi:10.1002/ijgo.13963

"Suction Tube Uterine Tamponade" for treatment of refractory postpartum hemorrhage: Internal feasibility and acceptability pilot of a randomized clinical trial

Int J Gynaecol Obstet. 2022 Jul;158(1):79-85. doi: 10.1002/ijgo.13963. Epub 2021 Oct 26.

Authors

Sylvia N Cebekhulu¹, Hazmath Abdul², Joanne Batting³, Lawrence Chauke⁴, Fuziwe Dlakavu⁵, Sue Fawcus⁶, Logie Govender², Busiwe Majeke⁷, Xolani Mbongozi⁸, Mandisa Singata-Madliki³, Katrin Middleton⁹, Philiswa Mlandu¹⁰, Poovangela Naidoo¹⁰, Sanele Ndaba¹¹, Priya Soma-Pillay¹², Trevi Spence¹³, Symphorien C Ntambua¹⁴, Justus Hofmeyr^{3

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Affiliations

¹ Department of Obstetrics and Gynaecology, Department of Health, Bloemfontein, Bongani Regional Hospital, University of the Free State, Hartbeespoort, South Africa.
² Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.
³ Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.
⁴ Department of Obstetrics and Gynaecology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Witwatersrand, South Africa.
⁵ Department of Obstetrics and Gynaecology, Steve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.
⁶ Department Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
⁷ Department of Obstetrics and Gynaecology at Cecilia Makiwane Hospital, Walter Sisulu University, East London, South Africa.
⁸ Department of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa.
⁹ Department of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa.
¹⁰ Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.
¹¹ Department of Obstetrics and Gynaecology Kalafong Hospital, University of Pretoria, Pretoria, South Africa.
¹² UP/SAMRC Research Centre for Maternal, Fetal, Newborn and Child Healthcare Strategies, Department of Obstetrics and Gynaecology Steve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.
¹³ Department of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa.
¹⁴ Department of Health, Department of Obstetrics and Gynaecology, Bongani Regional Hospital, Free State, Hartbeespoort, South Africa.
¹⁵ University of Botswana, Botswana, South Africa.

PMID: 34605016
DOI: 10.1002/ijgo.13963

Abstract

Objective: To assess feasibility and acceptability of a novel, low-cost "Suction Tube Uterine Tamponade" (STUT) treatment for refractory postpartum hemorrhage (PPH).

Methods: We allocated patients with refractory PPH by randomly ordered envelopes to STUT or routine uterine balloon tamponade (UBT, Ellavi free-flow system) in 10 hospitals in South Africa. In the STUT group, a 24FG Levin stomach tube was inserted into the uterine cavity and vacuum created with a vacuum pump or manual vacuum aspiration syringe.

Results: For this internal pilot study, 12 participants were allocated to STUT and 12 to UBT. Insertion failed in one of each group and was recorded as difficult in 3/10 STUT and 4/9 UBT insertions respectively (five missing data). There were two laparotomies and one intensive care unit admission in the UBT group. Pain during STUT insertion was graded as none/mild in 9/10 and severe in 1/10. The experience of the STUT procedure was graded as fine in 4/11 and "uncomfortable but acceptable" in 7/11.

Conclusion: STUT is feasible and acceptable, justifying continuation of our trial. These data will also inform a large World Health Organization trial to test effectiveness of uterine tamponade methods. The numbers are too small to support any clinical recommendation.

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

Publication types

Randomized Controlled Trial

MeSH terms

Feasibility Studies
Female
Humans
Pilot Projects
Postpartum Hemorrhage* / therapy
Pregnancy
Suction
Treatment Outcome
Uterine Balloon Tamponade* / methods