Post Partum HemorrhageNCT05559840
S-Condom Uterine Tamponade in Controlling Atraumatic Postpartum Haemorrhage (PPH) - RCT
A study testing S-Condom Uterine Tamponade and Traditional condom catheter in people with Post Partum Hemorrhage, run by Mamms Institute of Fistula and Womens Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- S-Condom Uterine Tamponade and Traditional condom catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 this study
Official title: S-Condom Uterine Tamponade Using Air Media in Controlling Atraumatic Postpartum Haemorrhage (PPH) - a Randomized Control Trial (RCT)
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.
Read the 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.
- Conditions
- Post Partum Hemorrhage
- Being tested
- S-Condom Uterine Tamponade, Traditional condom catheter
- Keywords
- Randomised controlled trial, S-condom, postpartum haemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Condom Uterine TamponadeDevice
The condom catheter will be inflated with air
Traditional condom catheterDevice
The condom catheter will be inflated with saline following national protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: S-Condom Uterine Tamponade |
| Group II | Experimental | The study group (Group II) will receive condom catheter that will be inflated with air Receives: Device: Traditional condom catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required to stop bleeding
Comparison of the average time to stop bleeding following the intervention and the control
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mamms Institute of Fistula and Womens Health
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, Dr. Sayeba Akhter, Mamms Institute of Fistula and Womens Health
- Investigators
- Sayeba Akhter, Dr., Principal investigator, Mamms Institute of Fistula and Womens Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559840
- Sponsor's protocol ID
- CMC/PG/2017/39
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-Condom Uterine Tamponade Using Air Media in Controlling Atraumatic Postpartum Haemorrhage (PPH) - a Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT05559840
- Acronym / sponsor ID
- CMC/PG/2017/39
- Conditions
- Post Partum Hemorrhage
- Keywords
- Randomised controlled trial, S-condom, postpartum haemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Mamms Institute of Fistula and Womens HealthUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: S-Condom Uterine TamponadeThe control group (Group I) will be treated with condom catheter tamponade by inflating the condom with saline according to national protocol. |
| Group II | Experimental | Device: Traditional condom catheterThe study group (Group II) will receive condom catheter that will be inflated with air |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-Condom Uterine TamponadeThe condom catheter will be inflated with air | Device | Group I |
| Traditional condom catheterThe condom catheter will be inflated with saline following national protocol | Device | Group II |
Primary outcome
Time required to stop bleeding
Time frame: 2 years
Comparison of the average time to stop bleeding following the intervention and the control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No. 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
Related trials for Post Partum Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayeba Akhter, Dr. principal investigator
Mamms Institute of Fistula and Womens Health
Questions about this trial
What is this clinical trial studying?
A study testing S-Condom Uterine Tamponade and Traditional condom catheter in people with Post Partum Hemorrhage, run by Mamms Institute of Fistula and Womens Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required to stop bleeding (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.