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"Suction Tube Uterine Tamponade" for treatment of refractory postpartum hemorrhage: Internal feasibility and acceptability pilot of a randomized clinical trial.
Cebekhulu, Sylvia N; Abdul, Hazmath; Batting, Joanne; Chauke, Lawrence; Dlakavu, Fuziwe; Fawcus, Sue; Govender, Logie; Majeke, Busiwe; Mbongozi, Xolani; Singata-Madliki, Mandisa; Middleton, Katrin; Mlandu, Philiswa; Naidoo, Poovangela; Ndaba, Sanele; Soma-Pillay, Priya; Spence, Trevi; Ntambua, Symphorien C; Hofmeyr, Justus.
Afiliación
  • Cebekhulu SN; Department of Obstetrics and Gynaecology, Department of Health, Bloemfontein, Bongani Regional Hospital, University of the Free State, Hartbeespoort, South Africa.
  • Abdul H; Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.
  • Batting J; Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.
  • Chauke L; Department of Obstetrics and Gynaecology, Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Witwatersrand, South Africa.
  • Dlakavu F; Department of Obstetrics and Gynaecology, Steve Biko Academic Hospital, University of Pretoria, Pretoria, South Africa.
  • Fawcus S; Department Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
  • Govender L; Department of Obstetrics & Gynaecology, Queen Nandi Regional Hospital, Empangeni, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.
  • Majeke B; Department of Obstetrics and Gynaecology at Cecilia Makiwane Hospital, Walter Sisulu University, East London, South Africa.
  • Mbongozi X; Department of Obstetrics and Gynaecology, Nelson Mandela Academic Hospital, Walter Sisulu University, Mthatha, South Africa.
  • Singata-Madliki M; Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.
  • Middleton K; Department of Obstetrics and Gynaecology, Frere Hospital and Walter Sisulu University, East London, South Africa.
  • Mlandu P; Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.
  • Naidoo P; Department of Obstetrics and Gynaecology, Chris Hani Baragwaneth Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa.
  • Ndaba S; Department of Obstetrics and Gynaecology Kalafong Hospital, University of Pretoria, Pretoria, South Africa.
  • Soma-Pillay P; 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.
  • Spence T; Department of Obstetrics and Gynaecology, New Somerset Hospital, Cape Town, South Africa.
  • Ntambua SC; Department of Health, Department of Obstetrics and Gynaecology, Bongani Regional Hospital, Free State, Hartbeespoort, South Africa.
  • Hofmeyr J; Effective Care Research Unit, Eastern Cape Department of Health, Universities of the Witwatersrand, Walter Sisulu, and Fort Hare, East London, South Africa.
Int J Gynaecol Obstet ; 158(1): 79-85, 2022 Jul.
Article en En | MEDLINE | ID: mdl-34605016
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.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Taponamiento Uterino con Balón / Hemorragia Posparto Tipo de estudio: Clinical_trials / Guideline Límite: Female / Humans / Pregnancy Idioma: En Revista: Int J Gynaecol Obstet Año: 2022 Tipo del documento: Article País de afiliación: Sudáfrica
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Taponamiento Uterino con Balón / Hemorragia Posparto Tipo de estudio: Clinical_trials / Guideline Límite: Female / Humans / Pregnancy Idioma: En Revista: Int J Gynaecol Obstet Año: 2022 Tipo del documento: Article País de afiliación: Sudáfrica