Further study of the inhibition of premature labor by indomethacin. Part II double-blind study

Abstract

In the etiology of premature labor prostaglandins fulfill a significant role. It is known that indomethacin is a strong inhibitor of prostaglandin synthesis. The effect of indomethacin on premature labor was studied in a prospective randomized double-blind study in 36 patients. Eighteen patients received indomethacin and eighteen received placebo. 200-300 mg of indomethacin was the total dosage in a 24 hours period. The activity of the uterus was monitored with a cardiotocograph. The mean duration of pregnancy and the mean birth weight in indomethacin group (36.4 weeks, 2833 g) were both significantly greater (p less than 0.001) than that in placebo group (31.2 weeks, 2028 g). In the indomethacin group 3 children weighted less than 2500 g compared with 14 in placebo group. In 15 of 18 indomethacin treated patients (83.3%) premature labor was arrested after indomethacin treatment compared with 4 of 18 in the placebo group (22.2%). The indomethacin group had a mean 1 minute APGAR score of 9.3 +/- 0.2 whereas the placebo group showed a score of 7.8 +/- 0.5 (p less than 0.01). Three infants died from respiratory distress syndrome; one in the indomethacin group (1810 g) and two in the placebo group (600 and 1450 g). Autopsies in the infants demonstrated a typical picture of pulmonary atelectasis and hyaline membranes. There was no evidence of premature closure of the ductus arteriosus or pulmonary hypertension. 2 mothers in the indomethacin group suffered minor discomfort i.e. nausea, vomiting and vertigo.(ABSTRACT TRUNCATED AT 250 WORDS)