The child had HIE and died after seven days. Uterine hyperstimulation accompanied by severe hypoxic fetal heart rate patterns with meconium followed. In 1999, a 33-year-old gravida 3, para 1, ab 1, with no previous c-section was given misoprostol vaginally, 50 mcg every four hours X 2, for a total 100 mcg, followed by oxytocin drip. The mother developed disseminated intravascular coagulopathy requiring massive blood transfusion. Uterine hyperstimulation was followed by uterine rupture. In 1998, a 35-year-old gravida 9, para 5, with no previous c-section was given misoprostol vaginally, 50 mcg every four to six hours X 3, for a total 150 mcg, with no oxytocin. The child has severe HIE with cerebral palsy and mental retardation. Uterine hyperstimulation with severe hypoxic fetal heart rate patterns occurred. In 1998, a 24-year-old primip was given misoprostol, 25 mcg orally, then after four hours 50 mcg orally every four hours X 7, for a total 375 mcg, followed by oxytocin drip. Uterine hyperstimulation with severe hypoxic fetal heart rate patterns was followed by uterine rupture. In 1998, a 32-year-old gravida 3, para 1, ab 1, with one previous c-section was given 25 mcg misoprostol vaginally, then after four hours 25 mcg, then six hours later 50 mcg, for a total 100 mcg, with no oxytocin. The child has HIE with cerebral palsy and mental retardation.

In 1997, a 35-year-old gravida 3, para 2, with no previous c-section was given misoprostol vaginally, 50 mcg every four to six hours X 3, for a total 150 mcg, with no oxytocin. The baby died at three days of age from hypoxic ischemic encephalopathy (HIE). In 1995, a 34-year-old gravida 2, para 1, with previous caesarean section was given misoprostol vaginally, 25 micrograms (mcg) every four hours X 2, for a total 50 mcg, followed by oxytocin drip. As some claim the adverse effects of misoprostol for labor induction are limited to women with previous caesarean section or to improper dosage, this information is included in each case described below. Finally, all cases of hypoxic ischemic encephalopathy of the infants have been confirmed by EEG, MRI and pediatric neurological examination.

All cases of amniotic fluid embolism have been confirmed by the pathologists’ autopsy reports. All cases of uterine rupture are not just dehiscence but clear, significant ruptures of 6-18 cm, confirmed by the operative report on the emergency caesarean section done in each case of uterine rupture.

All cases of uterine hyperstimulation and hypoxic fetal heart rate patterns have been confirmed by thorough review of the electronic fetal monitoring strips.

In every case, I have carefully reviewed all prenatal, intrapartum, postpartum and neonatal medical records, including all electronic fetal monitoring strips all laboratory results, including maternal ultrasound examinations non-stress tests cord blood gases and the infant EEGs, MRIs and neurological examinations. In the past eight years, I have consulted on sixteen medico-legal cases involving adverse events following misoprostol induction of labor in the U.S.

The authors request information on cases of uterine rupture known to readers.”(1) This paper addresses this appeal. In January 2004, The Cochrane Library commented on the paucity of data on the serious risks of induction with misoprostol and asked for help: “The studies reviewed were not large enough to exclude the possibility of rare but serious adverse events, particularly uterine rupture, which has been reported anecdotally following misoprostol use in women with and without previous caesarean section. Some obstetricians, particularly in the U.S., continue to promote induction with misoprostol, even though the available evidence suggests possible serious risks including uterine rupture, maternal mortality and perinatal mortality. Food and Drug Administration, other national drug regulatory agencies, the pharmaceutical industry, the Cochrane Library nor a number of national obstetric organizations, including the British Royal College of Obstetricians and Gynaecologists.

“Off-label” use of misoprostol (Cytotec) for labor induction has been steadily increasing for 10 years, even though this use is approved neither by the U.S. Subscribe to Midwifery Today Magazine Introduction Editor’s note: This article first appeared in Midwifery Today, Issue 71, Autumn 2004.

Cytotec and amniotic fluid embolism