Hofmeyr 2019.

Study name	STUT study Uterine vacuum tamponade for treatment of postpartum haemorrhage: a randomized study
Methods	RCT
Participants	Women (over 18 years of age) with PPH Exclusions: PPH due to cervical/vaginal tears Plan to include 84 participants
Interventions	Suction tube uterine tamponade Standard care control
Outcomes	Primary Measured blood loss within 60 minutes after enrolment >median for the control group (lognormal distribution comparison), or operative procedures (e.g. laparotomy, hysterectomy) or death Secondary Mean blood loss within 60 minutes after enrolment Blood loss within 60 minutes after enrolment > 500 mL (lognormal distribution comparison) or operative procedures (e.g. laparotomy, hysterectomy) or death Blood pressure, pulse and shock index 10 minutes after enrolment Change in Hb levels pre‐ delivery to post delivery Blood transfusion or death; ICU admission or death Death
Starting date	1 August 2019 (planned)
Contact information	Justus Hofmeyr (justhof@gmail.com) ‐ Principal investigator
Notes	PACTR201907769424884 Funding source: trial sponsored by the University of Witwatersrand, South Africa Recruitment status: not yet recruiting Ethical approval: Yes (approved by the University of Witwatersrand Human Research Ethics Committee)