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Randomized feasibility study of suction‐tube uterine tamponade for postpartum hemorrhage
Author(s) -
Hofmeyr G. Justus,
Middleton Katrin,
SingataMadliki Mandisa
Publication year - 2019
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1002/ijgo.12889
Subject(s) - medicine , tamponade , randomized controlled trial , surgery , uterus , suction , uterine cavity , blood loss , confidence interval , uterine rupture , catheter , tube (container) , mechanical engineering , engineering
Abstract Objective To identify an inexpensive catheter suitable for uterine suction tamponade ( UST ) for postpartum hemorrhage and assess its functionality. Methods Randomized, single‐center, double‐blind feasibility study in East London, South Africa, among 45 women undergoing cesarean delivery between October and November 2018. A search of medical supply websites for catheters with predefined characteristics (inexpensive, flexible, wide‐bore, circumferentially‐arranged side apertures, rounded tip) identified the FG 36 Levin stomach tube. During cesarean, the tube was placed in the uterus and connected transvaginally to a suction unit. Participants were randomized via a computer‐generated random sequence to early (after uterine closure; n=24) or delayed (after skin closure; n=21) UST . Results The tube functioned well with respect to stability in the uterus and aspirating blood from the uterine cavity without blockage. Blood loss was similar between the groups (mean difference, 7.3 mL ; 95% confidence interval, −61 to 75; P =0.433), as were secondary outcomes. There were no complications. Absolute effectiveness was not tested because there was no non‐suction group. Conclusion The FG 36 Levin tube was found to be a suitable device for “suction‐tube uterine tamponade”. There was no difference in functionality between early and late UST . Future trials should assess the effectiveness of this approach for postpartum hemorrhage. Clinical trial registration: Registered in the Pan African Clinical Trial Registry as PACTR 201809584199573.