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Search / Trial NCT05559840

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

Launched by MAMMS INSTITUTE OF FISTULA AND WOMENS HEALTH · Sep 26, 2022

Trial Information

Current as of May 19, 2025

Completed

Keywords

Randomised Controlled Trial, S Condom, Postpartum Haemorrhage

ClinConnect 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. 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 quantit...

Gender

FEMALE

Eligibility criteria

  • 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.

About Mamms Institute Of Fistula And Womens Health

The Mamms Institute of Fistula and Women's Health is a pioneering clinical research organization dedicated to advancing the understanding and treatment of obstetric fistula and other women's health issues. With a commitment to improving health outcomes for women, the Institute conducts innovative clinical trials and research initiatives aimed at developing effective therapies and interventions. By collaborating with healthcare professionals and leveraging cutting-edge methodologies, Mamms Institute seeks to enhance the quality of care for women suffering from fistula and related conditions, while promoting education and awareness in the wider community.

Locations

Patients applied

0 patients applied

Trial Officials

Sayeba Akhter, Dr.

Principal Investigator

Mamms Institute of Fistula and Womens Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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