Neonatal outcome after exposure to indomethacin in utero: a retrospective case cohort study.
OBJECTIVE
This study was undertaken to determine the clinical outcome for neonates who were exposed to indomethacin during gestation.


METHODS
We identified 124 infants with in utero exposure to indomethacin and matched them to 124 infants whose mothers did not receive indomethacin. The two groups were matched for gestational age at birth, sex, and exposure to antenatal betamethasone. Sixty-two of the indomethacin-exposed infants were born within 48 hours of last exposure. These infants were also compared with their matched controls.


RESULTS
There were no significant differences between the indomethacin-exposed infants and control infants in birth weight, Apgar scores, frequency of cesarean section deliveries, and multiple gestation. The incidence of respiratory distress syndrome, need for surfactant treatment, patent ductus arteriosus, necrotizing enterocolitis, and intraventricular hemorrhage was similar between the indomethacin-exposed group and the control group. Indomethacin-exposed infants who were born within 48 hours of last exposure had similar incidence of respiratory distress syndrome but greater need for surfactant treatment (P=.02) compared with controls. All other complication rates were similar.


CONCLUSIONS
Indomethacin exposure in our study was not associated with increased neonatal complications for infants delivered within or beyond 48 hours of last exposure.
Abbasi
Soraya
S
Section of Newborn Pediatrics and Maternal-Fetal Medicine, Pennsylvania Hospital, Departments of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia 19107, USA.
Gerdes
Jeffrey S
JS
Sehdev
Harish M
HM
Samimi
Sara S
SS
Ludmir
Jack
J
D001034:Apgar Score; D001623:Betamethasone / Q000008:administration & dosage; D001724:Birth Weight; D002585:Cesarean Section / Q000706:statistics & numerical data; D015331:Cohort Studies; D005260:Female; D005312:Fetal Blood / Q000737:chemistry; D005865:Gestational Age; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007213:Indomethacin / Q000009:adverse effects*; D007231:Infant, Newborn; D008297:Male; D008431:Maternal-Fetal Exchange; D011247:Pregnancy; D011272:Pregnancy, Multiple; D011663:Pulmonary Surfactants / Q000627:therapeutic use; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy / Q000453:epidemiology; D012189:Retrospective Studies; D015149:Tocolytic Agents / Q000009:adverse effects*; D014427:Twins
D011663:Pulmonary Surfactants; D015149:Tocolytic Agents; D001623:Betamethasone; D007213:Indomethacin