A double‐blind placebo controlled randomised trial of misoprostol and oxytocin in the management of the third stage of labour

Abstract

Objective To compare oral misoprostol 400 pg with intramuscular oxytocin 10 IU in the routine Design Double-blind placebo controlled trial.Setting Main referral hospital and its associated polyclinics in Accra, Ghana.Population Four hundred and one low risk women, in the second stage of labour with anticipated vaginal delivery, who entered labour spontaneously.Methods After delivery of the anterior shoulder of the baby, the women were randomised to receive either: 1. misoprosto1400 pg powder in water orally and 1 mL normal saline intramuscular injection (placebo); or 2. powdered cellulose in water orally (placebo) and 1 mL oxytocin 10 IU intramuscular injection.Main outcome measures Change in haemoglobin concentration from before delivery to 12 hours postpartum. Secondary outcomes included need for additional oxytocics, blood loss > 500 mL and > 1000 mL, operative intervention for postpartum haemorrhage, and side effects, including nausea, vomiting, diarrhoea, shivering and elevated temperature.Results Demographic characteristics were similar. There was no Significant difference in change in haemoglobin concentration between the two groups (0.60 g/dL for misoprostol and 0.55 g/dL for oxytocin; relative difference 9.6%; 95% CI 20.5-39.6%; P = 0.54). There were no significant differences in secondary outcomes with the exception of shivering, which occurred more frequently in the misoprostol group (22.2% vs 5.7%; relative risk 4.73; 95% CI 2-31-9968; P < 0.0001).Conclusions In low risk women oral misoprostol appears to be as effective in minimising blood loss in the third stage of labour as intramuscular oxytocin. Shivering was noted more frequently with misoprostol use, but no other side effects were noted. Misoprostol has great potential for use in the third stage of labour especially in developing countries.management of the third stage.

Active management of third stage of labour with low doses of oral misoprostol and oxytocin on low: risk parturient in a Sub-Saharan hospital, Dakar, Sénégal

“…Our observations were identical to those of most authors who had administered a 400 mcg dose of misoprostol via the oral route rectally. 9,10,19,22,24,27 However, it should be noted that the observed frequency in the misoprostol group in our study is close to the 9.3% reported by Zacharia and much lower than the 43.6% observed by Kundodyiwa. 19,24 Higher levels are reported with an oral dose of 500 mcg by El Refaey (72%).…”

“…Our results are consistent with those of Bulgaho, Walley, Zachariah, Afolabi and Caliskan who orally or rectally administered doses of 400 to 500 mcg of misoprostol comparing it to oxytocin or syntometrine. 9,10,19,22 Bellad observed a greater effectiveness of 400 mcg of misoprostol via the perlingual route over 10 IU IM oxytocin. 21 The need for additional oxytocics to limit blood loss is another criterion for measuring the therapeutic effectiveness of uterotonics used as first-line treatment.…”

“…Transfusion requirements reported in AMTSL with misoprostol are variable: 0% for Walley (400 mcg per os), 0.1% for Zachariah (400 mcg perlingual), 0.6% for Bulgaho (400 mcg rectally), 2% for El Refeay (500 mcg per os) and 3% for Caliskan in Turkey who reported an identical value to ours. 9,10,18,19,22 In these studies. There was no statistically significant difference with the control group that received 10 IU IM oxytocin.…”

“…17,18,25 No superiority of one treatment over the other was noted in the various studies where 400/500 mcg of misoprostol per os/perlingual was compared to oxytocin and/or Syntometrine®. 9,10,19,21,23 It shall be noted that Cook. Comparing 400 mcg of orally administered misoprostol to oxytocin and/or Syntometrine®.…”

“…But lead to differing and sometimes contradictory results regarding its effectiveness. [7][8][9][10][11][12] Indeed misoprostol or oxytocin doses and routes of administration were wideranging in these studies; moreover active delivery techniques were not always clearly stated or differed from one study to the other.…”