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

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
S-Condom Uterine Tamponade
Traditional condom catheter
Sponsored by
Mamms Institute of Fistula and Womens Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage focused on measuring Randomised controlled trial, S-condom, postpartum haemorrhage

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group I

    Group II

    Arm Description

    The control group (Group I) will be treated with condom catheter tamponade by inflating the condom with saline according to national protocol.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2022
    Last Updated
    September 26, 2022
    Sponsor
    Mamms Institute of Fistula and Womens Health
    Collaborators
    International Centre for Diarrhoeal Disease Research, Bangladesh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05559840
    Brief Title
    S-Condom Uterine Tamponade in Controlling Atraumatic Postpartum Haemorrhage (PPH) - RCT
    Official Title
    S-Condom Uterine Tamponade Using Air Media in Controlling Atraumatic Postpartum Haemorrhage (PPH) - a Randomized Control Trial (RCT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mamms Institute of Fistula and Womens Health
    Collaborators
    International Centre for Diarrhoeal Disease Research, Bangladesh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Partum Hemorrhage
    Keywords
    Randomised controlled trial, S-condom, postpartum haemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Active Comparator
    Arm Description
    The control group (Group I) will be treated with condom catheter tamponade by inflating the condom with saline according to national protocol.
    Arm Title
    Group II
    Arm Type
    Experimental
    Arm Description
    The study group (Group II) will receive condom catheter that will be inflated with air
    Intervention Type
    Device
    Intervention Name(s)
    S-Condom Uterine Tamponade
    Intervention Description
    The condom catheter will be inflated with air
    Intervention Type
    Device
    Intervention Name(s)
    Traditional condom catheter
    Intervention Description
    The condom catheter will be inflated with saline following national protocol
    Primary Outcome Measure Information:
    Title
    Time required to stop bleeding
    Description
    Comparison of the average time to stop bleeding following the intervention and the control
    Time Frame
    2 years

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Study participants are all pregnant women with post-partum haemorrhage.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sayeba Akhter, Dr.
    Organizational Affiliation
    Mamms Institute of Fistula and Womens Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    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

    Learn more about this trial

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

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