Background: Prolonged exposure of pregnant women to indomethacin for tocolysis may have significant effects on the fetus or neonate, but their incidence is still debated.
Population and methods: From January 1990 to July 1991, 83 pregnant women were prospectively given indomethacin for treatment of premature labor, after ineffective course of salbutamol. The initial dose of indomethacin was 100 mg, then the daily dose was 50 mg while salbutamol was continued. Indomethacin was discontinued beyond the 33rd week of gestational age. Efficacy of indomethacin was judged upon the disappearance of uterine contractions and the increased duration of pregnancy from the onset of treatment until delivery. Adverse effects of treatment were evaluated in the neonates.
Results: The mean duration of indomethacin administration was 16 days (range: 1-62 days); the mean total dose was 900 mg (range: 100-4500 mg). The reason for discontinuation of the treatment was its efficacy (41 patients), a gestational age of 33 weeks (12 patients), oligoamnios (21 patients), demonstration of fetal abnormalities (two patients). The mean interval between discontinuation of treatment and delivery was 5 weeks. Fourty three of the 58 patients who were given indomethacin before the 30rd week were delivered after the 33rd week. There was no adverse effect in the women and babies; all oligoamnios were spontaneously reversible. One hundred and fifteen babies were born including 12 who died during the first post-natal days. The rate of admission in an intensive care unit was similar to that of untreated pregnancies.
Conclusions: Indomethacin can be safely used for treatment of premature labor provided that its administration is carefully monitored.