[Has the use of indomethacin during pregnancy consequences in newborn infants? Prospective study of 83 pregnant women and 115 newborn infants].
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.


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.
Service de gynécologie-obstétrique, hôpital Robert-Debré, Paris, France.
O
O
Sibony
A
A
de Gayffier
L
L
Carbillon
J F
JF
Oury
C
C
Boissinot
J F
JF
Germain
E
E
Jacqz-Aigrain
P
P
Blot
D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000139:chemically induced* / Q000453:epidemiology; D007752:Obstetric Labor, Premature / Q000188:drug therapy; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011446:Prospective Studies; D015145:Tocolysis
D007213:Indomethacin
L'utilisation d'indométacine pendant la grossesse a-t-elle des conséquences chez le nouveau-né? Etude prospective de 83 parturientes et 115 nouveau-nés.