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

Department of Obstetrics and Gynaecology, Bongani Regional Hospital, University of the Free State, Department of Health, Bloemfontein, South Africa and NCCEMD Deputy chairperson. Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University of KwaZulu-Natal, KZN, SA. Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa. Department Obstetrics and Gynaecology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, South Africa. Department of Obstetrics and Gynaecology, Steve Biko Academic hospital, University of Pretoria. Department Obstetrics and Gynaecology, University of Cape Town, South Africa; and NCCEMD committee member. Department of Obstetrics and Gynaecology at Cecilia Makiwane hospital, and Walter Sisulu university. Department of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa. Department of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa. Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa. Department of Obstetrics and Gynaecology Kalafong hospital, University of Pretoria, South Africa. University of Pretoria, UP/SAMRC Research Centre for Maternal, Fetal, Newborn and Child Healthcare Strategies, Department of Obstetrics and Gynaecology Steve Biko Academic hospital, South Africa. Department of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa. Department of Obstetrics and Gynaecology, Bongani Regional Hospital, Free State, Department of Health, South Africa. Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa; University of Botswana, Botswana.

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2021

Other resources

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 ten 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 (5 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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine