Evaluation of intrauterine balloon tamponade efficacy with condom catheter in the severe postpartum hemorrhage management in Benin and Mali

Evaluation of intrauterine balloon tamponade efficacy with condom catheter and misoprostol (usual treatment) compared to misoprostol alone in the severe postpartum management hemorrhage management in Benin and Mali: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01202389

Enrollment

110

Registered

2013-09-09

Start date

2013-10-14

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecology-obstetrical/severe postpartum hemorrhage Pregnancy and Childbirth Postpartum haemorrhage

Interventions

The first line of post-partum hemorrhage (PPH) management is an injection of oxytocin + the realisation of an uterine massage and a uterine revision. These 3 treatments have to be realised jointly. Th

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Having given birth by vaginal way, in one of the selected establishments 2. After 28 weeks of amenorrhea, or foetus > 1000 g 3. Presenting a HPPI resisting the oxytocine and the first-line laborers (uterine massage + uterine revision) 4. Having given its oral consent

Exclusion criteria

Exclusion criteria: 1. Having given birth by caesarian 2. Presenting a contraindication or an allergy known about prostaglandins 3. Presenting an allergy to latex 4. Presenting a clinical Chorioamnionitis 5. Presenting a secondary postpartum hemorrhage, cervico-vaginal tears without uterine bleeding, an uterine break, or a placenta accreta

Design outcomes

Primary

Measure	Time frame
The primary outcome is a composite outcome: individual recourse to an invasive surgery (arterial ligatures, uterine compressive sutures, hysterectomy of haemostasis) and/or maternal death before the hospital release	—

Secondary

Measure	Time frame
Each element of the composite primary outcome is related to the point 1 and 2 only. So the secondary outcomes are formed by the 2 elements of the primary outcome measured separately and we will also measure three other outcomes: bleedings>1000 mL, necessity of a transfusion, necessity of a transfer. 1. Invasive intervention rate (arterial ligatures, uterine compressive sutures or hysterectomy of haemostasis): number of women having received an invasive intervention divided by the number of women included 2. Hospital maternal mortality rate (number of women included in the study and died before the hospital release divided by the number of inclusive women) 3. Bleeding > 1000 mL. 4. Necessity of a transfusion 5. Necessity of a transfer	—

Measure

Time frame

Each element of the composite primary outcome is related to the point 1 and 2 only. So the secondary outcomes are formed by the 2 elements of the primary outcome measured separately and we will also measure three other outcomes: bleedings>1000 mL, necessity of a transfusion, necessity of a transfer. 1. Invasive intervention rate (arterial ligatures, uterine compressive sutures or hysterectomy of haemostasis): number of women having received an invasive intervention divided by the number of women included 2. Hospital maternal mortality rate (number of women included in the study and died before the hospital release divided by the number of inclusive women) 3. Bleeding > 1000 mL. 4. Necessity of a transfusion 5. Necessity of a transfer

—

Countries

Benin, Mali

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026