MATERNAL AND NEONATAL EFFECTS OF INDOMETHACIN DURING PREGNANCY - A STUDY OF 18 CASES

Background. There have been several reports that prolonged exposure of pregnant women to indomethacin for tocolysis may have significant pha rmacological effects on the fetus or newborn. Patients. Eighteen pregn ant women were given indomethacin during the year 1989 for treatment o f premature labor (n = 16) or Polyhydramnios (n = 2). Treatment was st arted at gestational week 28.1+/-2.5 and was discontinued at gestation al week 30.7+/-1.8. The mean age of the women at the onset of pregnanc y was 30.6+/-5.3 years. The daily dose of indomethacin was initially 2 00 mg (2-3 mg/kg), then 107+/-59 mg. The cumulative dose was 1,820+/-2 .370 mg. The duration of treatment was 18.1+/-16.4 days (less than 7 d ays in 8 women). Results. The term at delivery was 33.4+/-3.3 weeks (1 1 after 32 weeks). The mean interval between discontinuation of treatm ent and delivery was 19.0+/-18.7 days. Indomethacin was effective in 1 0 cases of premature labor, and gestation was prolonged by 52.6+/-19.2 days. Among the 23 five-born neonates, 5 developed renal insufficienc y attributed to indomethacin (4 premature labor, 1 hydramnios). The ki dney failure with early hyperkalemia was cured within about 7 days in 4 cases. The remaining neonate also suffered from severe prolonged hyp oxia and died on day 4. Conclusions. Administration of indomethacin fo r premature labor places the fetus at risk because of the short drug-f ree interval before birth. High daily or cumulative doses of indometha cin dit not result in adverse effects.