Pregnancy outcome after exposure to misoprostol in Brazil: a prospective, controlled study.
BACKGROUND
Misoprostol, a synthetic prostaglandin E1 analog is labeled for the treatment of gastric and duodenal ulcers. In Brazil, where abortion is not a legal procedure, there is a widespread popular misuse of this drug in abortion attempts. This misuse and the fact that, in many cases the desired pregnancy termination does not occur, raise concerns about fetal safety. Case reports of congenital anomalies after maternal use of misoprostol have been published. The objective of this work was to compare pregnancy outcome following misoprostol exposure with a matched control group. This is the first prospective controlled study on fetal safety after misoprostol use.


METHODS
A prospective, observational cohort study with 86 exposed and 86 pair-matched, non-exposed controls.


RESULTS
There was no significant difference in the rates of major or minor birth between exposed compared to non-exposed infants (2/67 vs 2/81, major defects; 7/67 vs. 3/81, minor anomalies) There were significantly more miscarriages in the exposed group (17.1% vs. 5.8%; relative risk, 2.97; 95% confidence interval, 1.12 to 7.88). There was no statistical difference in gestational age at delivery, birth weight, sex ratio, rate of prematurity, low birth weight, or rates of cesarean section between groups.


CONCLUSIONS
Our study, despite its limited statistical power, does not suggest a potent teratogenic action of misoprostol exposure during pregnancy.
Schüler
L
L
Genetics Department, Universidade Federal do Rio Grande do Sul, Brazil.
Pastuszak
A
A
Sanseverino
T V
TV
Orioli
I M
IM
Brunoni
D
D
Ashton-Prolla
P
P
Silva da Costa
F
F
Giugliani
R
R
Couto
A M
AM
Brandao
S B
SB
Koren
G
G
D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000020:Abortifacient Agents, Nonsteroidal / Q000009:adverse effects*; D000024:Abortion, Illegal; D000028:Abortion, Induced; D000897:Anti-Ulcer Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001938:Brazil; D005260:Female; D005313:Fetal Death / Q000139:chemically induced; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D016595:Misoprostol / Q000009:adverse effects* / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000188:drug therapy; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies
D000020:Abortifacient Agents, Nonsteroidal; D000897:Anti-Ulcer Agents; D016595:Misoprostol