S-Condom Uterine Tamponade in Controlling Atraumatic Postpartum Haemorrhage (PPH) - RCT

Not Applicable

Completed

• Conditions: Post Partum Hemorrhage

• Registration Number: NCT05559840
• Lead Sponsor: Mamms Institute of Fistula and Womens Health

Brief Summary

A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility, acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not responding to first line of treatment.

Detailed Description

A Randomized Controlled Non inferiority Trial will be conducted to see the feasibility, acceptability and efficacy of S-Condom Uterine Tamponade in women with atraumatic PPH and not responding to first line of treatment. The women will be divided randomly into two groups, in both groups two condom tied on a catheter will be introduced inside the uterus. In one group (Control group), condom will be inflated with saline and in another group(study group) it will be inflated with air. Time required to stop bleeding will be measured for comparison. Data collected will be analyzed using a quantitative approach and the results will be presented in tables and graphs. If air media proved feasible, acceptable and effective the PPH management will be easier, cost-effective can make a great impact in reaching the target for reduction of maternal mortality in Bangladesh and other resource poor settings.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-29
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• All women who presented with atraumatic postpartum hemorrhage, refractory to first-line treatment (uterine massage and oxytocin) and who will give their consent will be included in the study and will be randomized

Exclusion Criteria

• Women known to have allergy to latex, or presenting with clinical chorioamnionitis or primary hemorrhage caused by cervical-vaginal lacerations, a uterine rupture, or a placenta accreta will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time required to stop bleeding	2 years	Comparison of the average time to stop bleeding following the intervention and the control