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Completed

NCT Number: NCT05559840

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-Condom Uterine Tamponade

Device

The condom catheter will be inflated with air

Traditional condom catheter

Device

The condom catheter will be inflated with saline following national protocol

Primary outcomes

  1. Time required to stop bleeding

    Time frame: 2 years

    Comparison of the average time to stop bleeding following the intervention and the control

Sponsors and collaborators

Lead sponsor

Mamms Institute of Fistula and Womens Health

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study title

S-Condom Uterine Tamponade Using Air Media in Controlling Atraumatic Postpartum Haemorrhage (PPH) - a Randomized Control Trial (RCT)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 29, 2022
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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