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

• Register: ISRCTN
• Last refreshed on: 13 March 2017
• Main ID: ISRCTN01202389
• Date of registration: 09/09/2013
• Prospective Registration: Yes
• Primary sponsor: Institute of Research for Development (Institut de Recherche pour le Développement) (IRD)
• Public title: Evaluation of intrauterine balloon tamponade efficacy with condom catheter in the severe postpartum hemorrhage management in Benin and Mali
• Scientific title: 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
• Date of first enrolment: 14/10/2013
• Target sample size: 110
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN01202389
• Study type: Interventional
• Study design: International randomized controlled trial multicenter open-label in two parallel groups (Treatment)
• Phase: Not Applicable

Countries of recruitment

Benin, Mali

Contacts

• Name: Alexandre Dumont

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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. Thus, if neither the injection of oxytocin, nor the uterine massage and the uterine revision allows to stop the PPH, the second line of PPH management has to be realized (administration of misoprostol or misoprostol + condom catheter tamponade.

Women presenting a postpartum hemorrhage resistant to oxytocin and first line laborers (uterine massage + uterine revision), will be randomized in order to receive:
1. The usual treatment to the posology of 5 tablets of Misoprostol 200 µg (intra-rectal) or 3 tablets of Misoprostol 200 µg (sub-lingual) immediately associated with an intrauterine balloon tamponade by condom-catheter
2. Only the usual treatment to the posology of 5 tablets of Misoprostol 200 µg (intra-rectal) or 3 tablets of Misoprostol 200 µg (sub-lingual)

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

TIUHPPI v15/04/2013

Source(s) of Monetary Support

Institute of Research for Development (Institut de Recherche pour le Développement) (IRD), Paris (France) (ref: TIUHPPI), Muskoka Fund for operational research, UNICEF, Regional Office for Central and Western Africa