• BJOG · Jul 2012

    Randomized Controlled Trial Comparative Study

    Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial.

    • M B Bellad, D Tara, M S Ganachari, M D Mallapur, S S Goudar, B S Kodkany, N L Sloan, and R Derman.
    • KLE University, Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.
    • BJOG. 2012 Jul 1; 119 (8): 975-82; discussion 982-6.

    ObjectiveSublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 μg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin.DesignDouble-blind randomised controlled trial.SettingA teaching hospital: J N Medical College, Belgaum, India.SampleA cohort of 652 consenting eligible pregnant women admitted to the labour room.MethodsSubjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively.Main Outcome MeasuresMeasured mean postpartum blood loss and haemorrhage (PPH, loss ≥ 500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects.ResultsThe mean blood loss with sublingual misoprostol was 192 ± 124 ml (n=321) and 366 ± 136 ml with oxytocin IM (n=331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P=0.002). No woman lost ≥ 1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group.ConclusionUnlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results.© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

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