Side effects of oral misoprostol for the prevention of postpartum hemorrhage: results of a community-based randomised controlled trial in rural India.
OBJECTIVE
To investigate the side effects of 600 microg oral misoprostol given for the mother and the newborn to prevent postpartum hemorrhage (PPH).


METHODS
One thousand six hundred twenty women delivering at home or subcentres in rural India were randomised to receive misoprostol or placebo in the third stage of labour. Women were evaluated for shivering, fever, nausea, vomiting and diarrhea at 2 and 24 h postpartum. Newborns were evaluated within 24 h for diarrhea, vomiting and fever. Symptoms were graded as absent, mild-to-moderate or severe.


RESULTS
Women who received misoprostol had a significantly greater incidence of shivering (52%vs. 17%, p < 0.001) and fever (4.2%vs. 1.1%, p < 0.001) at 2 h postpartum compared with women who received placebo. At 24 h, women in the misoprostol group experienced significantly more shivering (4.6%vs. 1.4%, p < 0.001) and fever (1.4%vs. 0.4%, p < 0.03). There were no differences in nausea, vomiting or diarrhea between the two groups. There were no differences in the incidence of vomiting, diarrhea or fever for newborns.


CONCLUSIONS
Misoprostol is associated with a significant increase in postpartum maternal shivering and fever with no side effects for the newborn. Given its proven efficacy for the prevention of PPH, the benefits of misoprostol are greater than the associated risks.
Patted
Shobhana S
SS
Department of Obstetrics and Gynecology, Jawaharal Nehru Medical College, Belgaum, India. shobhanapatted@yahoo.com
Goudar
Shivaprasad S
SS
Naik
Vijaya A
VA
Bellad
Mrutyunjaya B
MB
Edlavitch
Stanley A
SA
Kodkany
Bhalchandra S
BS
Patel
Ashlesha
A
Chakraborty
Hrishikesh
H
Derman
Richard J
RJ
Geller
Stacie E
SE
D000284:Administration, Oral; D003968:Diarrhea, Infantile / Q000139:chemically induced / Q000453:epidemiology; D005260:Female; D005334:Fever / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007194:India / Q000453:epidemiology; D007231:Infant, Newborn; D008431:Maternal-Fetal Exchange / Q000187:drug effects; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects*; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D010120:Oxytocics / Q000008:administration & dosage / Q000009:adverse effects; D010919:Placebos; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D012111:Residence Characteristics; D012424:Rural Population; D012768:Shivering / Q000187:drug effects; D014839:Vomiting / Q000139:chemically induced / Q000453:epidemiology
D010120:Oxytocics; D010919:Placebos; D016595:Misoprostol