Side effects of oral misoprostol during the first 24 hours after administration in the third stage of labour.
OBJECTIVE
To evaluate the side effects of 600 microg misoprostol orally during the first 24 hours after administration in the third stage of labour.


METHODS
Double blind randomised controlled trial.


METHODS
Tertiary care hospitals in Nigeria and Thailand.


METHODS
All women participating in the WHO Misoprostol trial in these two hospitals between January 1, 1999 and June 17, 1999.


METHODS
All women were followed up during the first 24 hours postpartum to evaluate the occurrence of shivering, nausea, vomiting, diarrhoea and other misoprostol-related side effects.


METHODS
Rates of shivering, nausea, vomiting, diarrhoea and pyrexia within 1 hour and in the intervals 2-6, 7-12, 13-18 and 19-24 hours after delivery.


RESULTS
A total of 1686 women were enrolled. Women who received misoprostol had higher incidence than the oxytocin group of 'any' shivering in the first hour (RR 6.4, 95% CI 3.9 to 10.4) and the period covering 2-6 hours following delivery (RR 4.7, 95% CI 1.9 to 11.2). Pyrexia was also more common in the misoprostol group in both the same time intervals (RR 2.8, 95% CI 1.4 to 5.3 and RR 6.3, 95% CI 3.7 to 10.8, respectively). Diarrhoea was not present in the first hour in either group but appeared in the second time period (2-6 hours) and third time period (7-12 hours) more frequently in the misoprostol group than with oxytocin.


CONCLUSIONS
The increased incidence of shivering and pyrexia that occurs with postpartum use of misoprostol persists up to 6 hours following delivery. Approximately 5% of women experience diarrhoea that starts after 1 hour and subsides within 12 hours.
Lumbiganon
Pisake
P
Department of Obstetrics and Gynaecology, Faculty of Medicine, Khon Kaen University, Thailand.
Villar
José
J
Piaggio
Gilda
G
Gülmezoglu
A Metin
AM
Adetoro
Lekan
L
Carroli
Guillermo
G
D000284:Administration, Oral; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005334:Fever / Q000139:chemically induced; D005500:Follow-Up Studies; D006801:Humans; D007749:Labor Stage, Third; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects*; D010120:Oxytocics / Q000008:administration & dosage / Q000009:adverse effects*; D006473:Postpartum Hemorrhage / Q000517:prevention & control*; D011247:Pregnancy; D011644:Puerperal Disorders / Q000139:chemically induced*; D012307:Risk Factors; D012768:Shivering; D013997:Time Factors
D010120:Oxytocics; D016595:Misoprostol