Administration of 400 μg of misoprostol to augment routine active management of the third stage of labor.
OBJECTIVE
To assess the effectiveness and safety of the administration of misoprostol, an orally active prostaglandin, in addition to routine uterotonic therapy as part of the active management of the third stage of labor.


METHODS
The present study was a hospital-based, decentralized, multi-center, randomized, placebo-controlled, double-blind trial. We enrolled 1103 women (out of a target sample size of 1180) at 4 hospitals in South Africa, Uganda, and Nigeria. Participants received a sublingual dose of 400 μg of misoprostol or a placebo, in addition to standard active management of the third stage of labor, after vaginal birth.


RESULTS
The baseline characteristics of the participants were comparable. The difference in the primary outcome of blood loss of 500 mL or more within 1 hour of randomization was not significant between the 2 groups (misoprostol 22/546 [4.0%] versus placebo 35/553 [6.3%]; relative risk, 0.64; 95% confidence interval, 0.38-1.07). Shivering and pyrexia occurred more frequently in the misoprostol group. No maternal deaths occurred.


CONCLUSIONS
The present study did not confirm a beneficial effect of administering 400 μg of misoprostol, in addition to routine uterotonic therapy, during the third stage of labor, but was consistent with other trials showing a cumulative modest benefit. Where routine uterotonics are available for prophylactic use, any potential benefit of misoprostol might not outweigh the likelihood of adverse effects.
Effective Care Research Unit, East London Hospital Complex, Eastern Cape, South Africa. justhof@gmail.com
G Justus
GJ
Hofmeyr
Bukola
B
Fawole
Kidza
K
Mugerwa
N Patrick
NP
Godi
Quentin
Q
Blignaut
Lindeka
L
Mangesi
Mandisa
M
Singata
Leanne
L
Brady
Jennifer
J
Blum
D000286:Administration, Sublingual; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007749:Labor Stage, Third; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009549:Nigeria; D010120:Oxytocics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D011446:Prospective Studies; D013019:South Africa; D016896:Treatment Outcome; D014454:Uganda; D055815:Young Adult
D010120:Oxytocics; D016595:Misoprostol