S-Condom Uterine Tamponade
DeviceThe condom catheter will be inflated with air
NCT Number: NCT05559840
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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Notify Me18 year–49 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The condom catheter will be inflated with air
The condom catheter will be inflated with saline following national protocol
Time frame: 2 years
Comparison of the average time to stop bleeding following the intervention and the control
Mamms Institute of Fistula and Womens Health
Other
S-Condom Uterine Tamponade Using Air Media in Controlling Atraumatic Postpartum Haemorrhage (PPH) - a Randomized Control Trial (RCT)
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