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

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
S-Condom Uterine Tamponade Using Air Media in Controlling Atraumatic Postpartum Haemorrhage (PPH) - a Randomized Control Trial (RCT)

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Device: S-Condom Uterine Tamponade
* Device: Traditional condom catheter


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>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<br>* The condom catheter will be inflated with air<br>|
| Experimental: Group II<br>The study group (Group II) will receive condom catheter that will be inflated with air | Device: Traditional condom catheter<br>* The condom catheter will be inflated with saline following national protocol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required to stop bleeding | Comparison of the average time to stop bleeding following the intervention and the control | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Randomised controlled trial, S-condom, postpartum haemorrhage