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Randomized controlled trial comparing 200 µg and 400 µg sublingual misoprostol for prevention of primary postpartum hemorrhage.
(2016) Ugwu, I. A.; Oluwasola, T. A. O.; Enabor, O. O.; Anayochukwu-Ugwu, N. N.; Adeyemi, A. B.; Olayemi, O. O.
Objective: To compare efficacy and adverse effects of 200 μg and 400μgmisoprostol for prevention of postpartum hemorrhage (PPH). Methods: In a randomized control trial, women with term singleton pregnancies in active labor attending University College Hospital, Ibadan, Nigeria, were enrolled between July 2011 and February 2012. Participants were randomly assigned using random numbers (block size four) to receive 200 μg or 400 μg sublingual misoprostol after delivery of the anterior shoulder, alongside intravenous oxytocin. Investigators were masked to group assignment, but participants were not. The primary outcomes were blood loss up to 1 h after delivery, PPH (blood loss ≥500 mL), and adverse effects. Results: Overall, 62 patients were assigned to each group. No significant differences between the 200-μg and 400-μg groups were recorded in mean per partum blood loss (307 ± 145 mL vs 296 ± 151 mL; P =0.679) and PPH occurrence (5 [8.1%] vs 6 [9.7%] women; P=0.752). Noticeable adverse effects were reported by 16 (25.8%) women in the 200-μg group and 42 (67.7%) in the 400-μg group (P b 0.001). Risk of shivering was significantly lower with 200 μg than 400 μg (relative risk 0.33, 95% confidence interval 0.19–0.58). Conclusion: Blood loss and PPH occurrence did not differ by misoprostol dose, but a 200-μg dose was associated with a reduction in adverse effects.
Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries
(BioMed Central (BMC), 2012) Shochet, T.; Diop, A.; Gaye, A.; Nayama, M.; Sall, A. B.; Fawole, B.; Blandie, T.; Okunlola, M. A; Dao, B.; Ogunbode, O. O.; Winkoff, B.
Background: In low-resource settings, where abortion is highly restricted and self-induced abortions are common, access to post-abortion care (PAC) services, especially treatment of incomplete terminations, is a priority. Standard post-abortion care has involved surgical intervention but can be hard to access in these areas. Misoprostol provides an alternative to surgical intervention that could increase access to abortion care. We sought to gather additional evidence regarding the efficacy of 400 mcg of sublingual misoprostol vs. standard surgical care for treatment of incomplete abortion in the environments where need for economical non-surgical treatments may be most useful. Methods: A total of 860 women received either sublingual misoprostol or standard surgical care for treatment of incomplete abortion in a multi-site randomized trial. Women with confirmed incomplete abortion, defined as past or present history of vaginal bleeding during pregnancy and an open cervical os. were eligible to participate. Participants returned for follow-up one week later to confirm clinical status. If abortion was incomplete at that time, women were offered an additional follow-up visit or immediate surgical evacuation. Results: Both misoprostol and surgical evacuation are highly effective treatments for incomplete abortion (misoprostol: 94.4%, surgical: 100.0%). Misoprostol treatment resulted in a somewhat lower chance of success than standard surgical practice (RR = 0.90; 95% Cl: 0.89-0.92). Both tolerability of side effects and women's satisfaction were similar in the two study arms. Conclusion: Misoprostol, much easier to provide than surgery in low-resource environments, can be used safely, successfully, and satisfactorily for treatment of incomplete abortion. Focus should shift to program implementation, including task-shifting the provision of post-abortion care to mid- and low- level providers, training and assurance of drug availability.
Oral misoprostol for the prevention of primary post-partum hemorrhage during third stage of labor
(2007-12) Enakpene, C. A.; Morhason-Bello, I.O.; Enakpene, E. O.; Arowojolu, A. O.; Omigbodun, A. O.
Aim: To assess the effectiveness of oral misoprostol compared with methylergometrine in the prevention of primary post-partum hemorrhage during the third stage of labor. Methods: This was a randomized controlled trial of 864 singleton low-risk pregnant women. The outcomes were total blood loss, duration of the third stage of labor and peripartal change in hematocrit. Comparisons were by the c2-test and Student t-test. Relative risks were calculated for side-effects profile. A P-value of less than 0.05 was statistically significant. Results: The biodata of all the participants were similar. The mean blood loss for the misoprostol and methylergometrine groups was 191.6 _ 134.5 mL and 246.0 _ 175.5 mL, respectively (95% CI: -79.3 to -39.5 mL). The mean duration of the third stage of labor was 19.6 _ 2.4 min and 9.4 _ 3.3 min in the misoprostol and methylergometrine groups, respectively (95% CI: 9.82–10.58 min). More subjects had blood loss >500 mL, 42 (9.7%) versus 6 (1.4%), and peripartal hematocrit change greater than 10%, 38 (8.8%) versus 5 (1.2%), in the methylergometrine group than in the misoprostol group, respectively. Also, more subjects received additional oxytocic in the methylergometrine group, compared to the misoprostol group (80 [18.5%] versus 33 [7.6%] patients, respectively). Conclusions: Orally administered misoprostol was more effective in reducing blood loss during the third stage of labor than intramuscular methylergometrine. However, there were more subjects in the misoprostol group in whom duration of the third stage of labor was greater than 15 min and who also had manual placental removal than in the methylergometrine group

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