Clinical Trials Logo
  1. Home
  2. Post Partum Hemorrhage
  3. NCT05559840
  4. Details
NCT05559840 Clinical Trial

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

Post Partum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05559840
Other study ID # CMC/PG/2017/39
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2019

Study information
Verified date September 2022
Source Mamms Institute of Fistula and Womens Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• S-Condom Uterine Tamponade
The condom catheter will be inflated with air
• Traditional condom catheter
The condom catheter will be inflated with saline following national protocol

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Mamms Institute of Fistula and Womens Health International Centre for Diarrhoeal Disease Research, Bangladesh

Outcome
Type Measure Description Time frame Safety issue
Primary Time required to stop bleeding Comparison of the average time to stop bleeding following the intervention and the control 2 years
See also
  Status Clinical Trial Phase
Completed NCT03680339 - The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS Phase 4
Completed NCT03693599 - Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean Phase 4
Completed NCT03707132 - Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Recruiting NCT02306733 - Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally Phase 3
Completed NCT01866241 - Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage Phase 3
Not yet recruiting NCT01236482 - Oxytocin in Cesarean Delivery Phase 4
Completed NCT03784794 - Patient Blood Management for Massive Obstetric Hemorrhage N/A
Enrolling by invitation NCT06255496 - QStat Cartridge in Obstetric Patients
Recruiting NCT04401839 - Amr Maneuver for Prevention of Postpartum Hemorrhage N/A
Not yet recruiting NCT06333340 - Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery N/A
Not yet recruiting NCT06219538 - DAISY Uterine Drain Device Evaluation N/A
Completed NCT01863706 - Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage Phase 1
Not yet recruiting NCT05488457 - Oxytocin Pharmacokinetics and Pharmacodynamics Phase 2
Terminated NCT04277962 - Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial N/A
Completed NCT04723979 - NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL
Completed NCT03570723 - Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa N/A
Completed NCT03117647 - Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage N/A
Active, not recruiting NCT03069859 - Use of TXA to Prevent Postpartum Hemorrhage Phase 2
Not yet recruiting NCT03891082 - A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section N/A
Not yet recruiting NCT03463070 - Misoprostol Before and After Cesarean Section Phase 3