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

NCT05559840 | Completed

• 1 other identifier: CMC/PG/2017/39
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Randomised controlled trial, S-condom, postpartum haemorrhage

Outcome Measures

Primary Outcomes (1)

• Time required to stop bleeding

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

  2 years

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

EXPERIMENTAL

The study group (Group II) will receive condom catheter that will be inflated with air

Device: Traditional condom catheter

Interventions

S-Condom Uterine Tamponade DEVICE

The condom catheter will be inflated with air

Group I

Traditional condom catheter DEVICE

The condom catheter will be inflated with saline following national protocol

Group II

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Study participants are all pregnant women with post-partum haemorrhage.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mamms Institute of Fistula and Womens Health: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sayeba Akhter, Dr.

  Mamms Institute of Fistula and Womens Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two treatment strategies will be compared in this pilot study. When PPH will be diagnosed, women will receive standard treatment, 10 units of oxytocin, uterine massage and aortic compression. If bleeding continue, the control group (Group I) will be treated with condom catheter tamponade by inflating the condom with saline according to national protocol. In case of study group (Group II) the condom will be inflated with air.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: January 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share