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

• Published in: BJOG : an international journal of obstetrics and gynaecology Vol. 119; no. 8; pp. 975 - 986
• Main Authors: Bellad, MB, Tara, D, Ganachari, MS, Mallapur, MD, Goudar, SS, Kodkany, BS, Sloan, NL, Derman, R
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.07.2012; Blackwell; Wiley Subscription Services, Inc
• Subjects: Administration, Sublingual; Adult; Biological and medical sciences; Clinical trials; Digestive system; Double-Blind Method; Drugs; Female; Gynecology. Andrology. Obstetrics; Haemoglobin; Hemorrhage; Humans; Medical sciences; misoprostol; Misoprostol - administration & dosage; Oxytocics - administration & dosage; oxytocin; Oxytocin - administration & dosage; Pharmacology. Drug treatments; postpartum blood loss; Postpartum Hemorrhage - prevention & control; Postpartum period; Powders; Pregnancy; Preventive medicine; Treatment Outcome; Young Adult; India; Prevention; Oxytocin; Antisecretory agent; Gynecology; Double blind study; Clinical trial; Antiulcer agent; Puerperium; Hemorrhage; Misoprostol; Obstetrics; Prostaglandin derivatives
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/j.1471-0528.2012.03341.x

Please cite this paper as: Bellad M, Tara D, Ganachari M, Mallapur M, Goudar S, Kodkany B, Sloan N, Derman R. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double‐blind randomised controlled trial. BJOG 2012;119:975–986. Objective  Sublingual 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. Design  Double‐blind randomised controlled trial. Setting  A teaching hospital: J N Medical College, Belgaum, India. Sample  A cohort of 652 consenting eligible pregnant women admitted to the labour room. Methods  Subjects 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 measures  Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥500 ml), >10% pre‐ to post‐partum decline in haemoglobin, and reported side effects. Results  The 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. Conclusion  Unlike 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.