misoprostol and Infant--Premature--Diseases

This study reports the occurrence of three cases of an unusual congenital malformation of the skull in neonates seen at a pediatric hospital during a five-month interval in Fortaleza, Brazil. The prenatal history focused on the mothers' exposure to drugs during pregnancy. It was found that all mothers had taken misoprostol orally and/or vaginally in the first trimester of pregnancy to induce abortion. Other drugs taken during pregnancy included iron, vitamins and tetanus toxoid. There was no evidence of a family history of malformations, consanguinity or clinical infective illnesses.. Three cases of an unusual congenital malformation of the skull occurred in newborns in Fortaleza, Brazil, over a 5-month period. In each case, the only unusual feature of the pregnancy history was the fact that the mothers had taken misoprostol orally and/or vaginally in the first trimester to induce an abortion. In the first case, the mother took 800 mcg of misoprostol orally at the time of expected menses and experienced slight vaginal bleeding and intense abdominal pain. The baby was born at 36 weeks gestation with a localized fronto-temporal defect with an asymmetric, well-circumscribe deficiency of the cranium and overlying scalp and exposure of the cerebrum and dura mater. After surgery to cover the defect, the child developed convulsions which are controlled by phenobarbital. In the second case, the mother took 600 mcg misoprostol at the time of expected menses and experienced spotting and pain. One month later, she repeated the dosage and experienced only spotting. The full-term baby had a localized frontal defect with an asymmetric, well-circumscribed absence of the cranium and overlying scalp, exposing the cerebrum and dura mater. A week after surgery to cover the defect, this child also developed convulsions. In the third case, the mother took 600 mcg misoprostol orally and 200 mcg vaginally at the time of expected menses. 4 weeks later she took 1200 mcg misoprostol orally and 400 mcg vaginally. After an otherwise normal pregnancy and delivery, the child was delivered with a complete deficit in the cranium and scalp in a localized region of the frontal-temporal area. This child died postoperatively. Controlled studies have not been performed to determine the effect of misoprostol during the first trimester of pregnancy, but no teratogenic effects were found in animals. The cases reported here suggest the need for further investigation of a possible association.

Topics: Abortion, Induced; Female; Humans; Infant, Newborn; Infant, Premature, Diseases; Male; Misoprostol; Pregnancy; Pregnancy Trimester, First; Prenatal Exposure Delayed Effects; Scalp; Skull; Treatment Failure