Refractory haEmorrhage Devices trial: Efficacy of uterine tamponade devices for management of refractory postpartum haemorrhage

Not Applicable

• Conditions: Refractory Postpartum haemorrhage; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12622000981729
• Lead Sponsor: DP-UNFPA-UNICEF-WHO-WORLD BANK special programme of research, development and research training in human reproduction (HRP). World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-13
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 2306

Inclusion Criteria

Women will be eligible for the trial if they provide consent, have a vaginal birth and experience PPH likely to be caused by uterine atony, not responding to first-line treatment with uterotonic drugs, and therefore require further treatment to control the bleeding according to the birth attendant’s opinion. These criteria apply for both Stage 1 and Stage 2.

Exclusion Criteria

Eligible women will not be randomized either if the clinical condition or the severity of the bleeding imply performing an invasive surgical procedure without delay at the judgment of the birth attendant in charge, or they present a clinical chorioamnionitis or in utero foetal death, they have been diagnosed with cervical cancer during pregnancy, have known uterine anomalies, or have allergy to trial device material . These criteria apply for both Stage 1 and Stage 2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified