Abstract
Animal studies and isolated human case reports have raised concerns about the possible premature closure of the ductus arteriosus (PDA) and pulmonary hypertension (PPHN) in the fetus exposed to indomethacin (indo). Although short term (<48 hrs) indo use for premature labor has been shown to be safe in humans, the side effects of long term (>48 hrs) use have not been well documented. The clinical course of 249 neonates during a 2 year period who were exposed in utero to tocolytic agents was evaluated. 24 pregnant women in preterm labor and failing parenteral tocolytics had indo added to their regimen (200-300 mg/day). Indo was continued until 33 wks. These infants were compared to those who received other tocolytic agents (control). Mean ±SD values for gestational age (GA, wks), duration of tocolytic exposure (Toco, wks), time in utero gained (TG, wks), PPHN, PDA, respiratory distress (RDS), infant mortality (Mort) for indo and control are:There was no difference between indo (n=30) and control babies (n=219) when matched by GA for BW, RDS, apnea, IVH or PDA.Conclusions: 1. The addition of indo in pregnancies complicated by preterm labor resistant to standard therapy prolonged gestation. 2. There was no significant risk of RDS, apnea, IVH or PDA in long term indo exposure prior to 33 wks gestation. 3. Sample size prevented risk analysis of PPHN, BPD, and mortality.
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