Misoprostol for treating postpartum haemorrhage: a randomized controlled trial [ISRCTN72263357]

Abstract

BackgroundPostpartum haemorrhage remains an important cause of maternal death despite treatment with conventional therapy. Uncontrolled studies and one randomised comparison with conventional oxytocics have reported dramatic effects with high-dose misoprostol, usually given rectally, for treatment of postpartum haemorrhage, but this has not been evaluated in a placebo-controlled trial.MethodsThe study was conducted at East London Hospital Complex, Tembisa and Chris Hani Baragwanath Hospitals, South Africa. Routine active management of the third stage of labour was practised. Women with more than usual postpartum bleeding thought to be related to inadequate uterine contraction were invited to participate, and to sign informed consent. All routine treatment was given from a special 'Postpartum Haemorrhage Trolley'. In addition, participants who consented were enrolled by drawing the next in a series of randomised treatment packs containing either misoprostol 5 × 200 μg or similar placebo, which were given 1 orally, 2 sublingually and 2 rectally.ResultsWith misoprostol there was a trend to reduced blood loss ≥500 ml in 1 hour after enrolment measured in a flat plastic 'fracture bedpan', the primary outcome (6/117 vs 11/120, relative risk 0.56; 95% confidence interval 0.21 to 1.46). There was no difference in mean blood loss or haemoglobin level on day 1 after birth < 6 g/dl or blood transfusion. Side-effects were increased, namely shivering (63/116 vs 30/118; 2.14, 1.50 to 3.04) and pyrexia > 38.5°C (11/114 vs 2/118; 5.69, 1.29 to 25). In the misoprostol group 3 women underwent hysterectomy of whom 1 died, and there were 2 further maternal deaths.ConclusionsBecause of a lower than expected incidence of the primary outcome in the placebo group, the study was underpowered. We could not confirm the dramatic effect of misoprostol reported in several unblinded studies, but the results do not exclude a clinically important effect. Larger studies are needed to assess substantive outcomes and risks before misoprostol enters routine use.

A Study to Compare the Efficacy of Misoprostol, Oxytocin, Methyl-ergometrine and Ergometrine–Oxytocin in Reducing Blood Loss in Active Management of 3rd Stage of Labor

“…The WHO defines PPH as blood loss of 500 ml or more in first 24 h post partum [2]. Postpartum blood loss is difficult to evaluate especially in developing country like India where most of the women are anaemic with poor reserve and this conditions are further aggravated by increased demand during pregnancy and blood loss during 3rd stage of labor [3]. The days of expectant management, the so called ''hands off'' [4] approach seems to be over, in view of serious consequences of PPH.…”

Postpartum Hemorrhage; Efficacy of Balloon Tamponade in the Management

“…Hofmeyr reported mean age of 27.1 years. 17 Walraven G showed mean age of 24.6 years. 18 In Africa where PPH appears to be more prevalent, studies had shown that at least 70% of woman are less than 30 years of age.…”

Nyttig bidrag for å redusere mødredødelighet

“…The three published trials (31)(32)(33) were relatively small, with a total of 465 women participating. The unpublished WHO-Gynuity trial (34) included 1400 women in Argentina, Egypt, South Africa, Thailand and Viet Nam.…”

“…Four trials assessed the use of misoprostol as an adjunct following active management of the third stage of labour with oxytocin (31)(32)(33)(34). The three published trials (31)(32)(33) were relatively small, with a total of 465 women participating.…”