O. Sibony et al., NEONATAL CONSEQUENCES OF THE USE OF INDOM ETHACIN DURING PREGNANCY - A PROSPECTIVE-STUDY OF 83 PREGNANT-WOMEN AND 115 NEWBORNS, Archives de pediatrie, 1(8), 1994, pp. 709-715
Background. - Prolonged exposure of pregnant women to indomethacin for
tocolysis may have significant effects on the fetus or neonate, but t
heir incidence is still debated. Population and methods. - From Januar
y 1990 to July 1991, 83 pregnant women were prospectively given indome
thacin for treatment of premature labor, after ineffective course of s
albutamol. The initial dose of indomethacin was 100 mg, then the daily
dose was 50 mg while salbutamol was continued. Indomethacin was disco
ntinued beyond the 33rd week of gestational age. Efficacy of indometha
cin was judged upon the disappearance of uterine contractions and the
increased duration of pregnancy from the onset of treatment until deli
very. Adverse effects of treatment were evaluated in the neonates. Res
ults. - The mean duration of indomethacin administration was 16 days (
range: 1-62 days); the mean total nose 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 be
fore the 30rd week were delivered after the 33rd week. There was no ad
verse effect in the women and babies; all oligoamnios were spontaneous
ly reversible. One hundred and fifteen babies were born including 12 w
ho died during the first post-natal days. The rare of admission in an
intensive care unit was similar to that of untreated pregnancies. Conc
lusions. - lndomethacin can be safely used for treatment of premature
labor provided that its administration is carefully monitored.