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

INTERVENTION: 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) CONDITION: Gynecology‐obstetrical/severe postpartum hemorrhage ; Pregnancy and Childbirth ; Postpartum haemorrhage PRIMARY OUTCOME: 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: 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 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