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

NCT05559840 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-09-29

No results posted yet for this study

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.

Conditions

  • Post Partum Hemorrhage

Interventions

DEVICE

S-Condom Uterine Tamponade

The condom catheter will be inflated with air

DEVICE

Traditional condom catheter

The condom catheter will be inflated with saline following national protocol

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Mamms Institute of Fistula and Womens Health

    lead OTHER

Principal Investigators

  • Sayeba Akhter, Dr. · Mamms Institute of Fistula and Womens Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05559840 on ClinicalTrials.gov