No reduction of manual removal after misoprostol for retained placenta: a double‐blind, randomized trial

Abstract

Objective. To test the effect of 800 lg of misoprostol orally on the prevention of manual removal of retained placenta. Design. Multicenter, doubleblinded, placebo-controlled, randomized trial. Setting. One university and one non-university teaching hospital in the Netherlands. Sample. 99 women with retained placenta (longer than 60 min after childbirth) in the absence of postpartum hemorrhage. Methods. Eligible women were administered either 800 lg of misoprostol or placebo orally. Main outcome measures. Number of manual removals of retained placenta and amount of blood loss. Results. Manual removal of retained placenta was performed in 50% of the women who received misoprostol and in 55% who received placebo (relative risk 0.91, 95% confidence interval 0.62-1.34). No difference in the amount of blood loss (970 vs. 1120 mL; p = 0.34) was observed between the two groups. Conclusions. Administration of 800 lg of oral misoprostol, one hour after childbirth, does not seem to reduce the number of manual removals of retained placentas. The time elapsing results in the delivery of 50% of the retained placentas at the expense of an increased risk of postpartum hemorrhage.Abbreviations: PPH, postpartum hemorrhage.

What is the optimal pharmacological management of retained placenta?

“…A meta-analysis of two small RCTs of oral misoprostol, a synthetic prostaglandin, found a reduction in the need to perform manual removal compared with placebo (0.61, 0.41 to 0.90; 84 participants). 4 However, other relevant outcomes including postpartum haemorrhage, infection, surgical evacuation of retained products of placenta, and maternal mortality were not reported.…”

“…The comparator should be standard care based on current practice (intraumbilical oxytocin) Outcome: Primary: delivery of the placenta within 60 minutes, avoiding the need for manual removal of the placenta. Secondary: postpartum haemorrhage, adverse events, and side effects Design: Multi-centre randomised controlled trial with factorial design Table Table 1| Meta-analysis of the effectiveness and safety of interventions to treat retained placenta 4 …”

“…In Spain, obstetricians perform the procedure at 30 minutes, in the UK NICE recommends that it is carried out at 60 minutes, whereas in Dutch hospitals obstetricians wait 60 minutes or more. 4 The natural course of retained placenta suggests that placentas that remain in situ 60 minutes after delivery of the baby will remain undelivered if a further 30 minutes is allowed to elapse. 2…”

Systematic review of prostaglandin analogues for retained placenta

“…1). Seven studies met the inclusion criteria [12][13][14][15][16][17][18] ; nine trials were excluded because they were not randomized controlled trials (n=6), were not original articles (n=2), or were a preliminary report (n=1). The included studies are described in Table S1.…”

“…For the random sequence generation domain, only four trials [12][13][14][15] appropriately reported the method used and were assessed as low risk of bias. For allocation concealment, five trials [14][15][16][17][18] adequately implemented a valid concealment of allocation method by using sequentially numbered sealed envelopes or containers with a similar appearance, making selection bias at enrollment unlikely.…”