An interventional study of S-Condom Uterine Tamponade and Traditional condom catheter in Post Partum Hemorrhage, sponsored by Mamms Institute of Fistula and Womens Health. Completed. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Mamms Institute of Fistula and Womens Health · Not applicable, Interventional, and Prevention
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.
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 82 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →This is the only study on the registry with Mamms Institute of Fistula and Womens Health as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control group (Group I) will be treated with condom catheter tamponade by inflating the condom with saline according to national protocol.
Device: S-Condom Uterine Tamponade
The study group (Group II) will receive condom catheter that will be inflated with air
Device: Traditional condom catheter
The condom catheter will be inflated with air
The condom catheter will be inflated with saline following national protocol
Time required to stop bleeding
Comparison of the average time to stop bleeding following the intervention and the control
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No — We will not share individual participant data with other researchers. We will remove all personal identifier after assigning unique ids to each participant before data entry
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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