A Randomized Comparison Between 25 Microgram Misoprostol Gel and 50 Microgram Misoprostol Vaginal Tablet for Induction of Labour

Abstract

Objective To compare the safety and effectiveness of intravaginal administered misoprostol at doses of 25 microgram gel and 50 microgram tablet for labor induction in patients with an unfavorable cervix.

Main outcome measures Mode of delivery, time taken from initial application of PGE2 to the full cervical dilatation and to the delivery,total dosage, uterine hyperstimulation, Apgar score and immediate newborn status at birth.

Results Among uncomplicated 166 patients evaluated, 83 patients were allocated to the 25 microgram group and 83 patients to the 50 micrograms group. The patients' characteristics were not different between two groups. (Maternal age, parity, height, weight, gestational age, initial bischop score, new born birth weight) The start-to-fully dilated cervix and start-to-delivery interval were equal between the 25 microgram and 50 microgram group. (846.132 minutes vs 910.324 minutes (p = 0.561) and 873.361 minutes vs 959.325 minutes (p = 0.471) respectively). The mean total dosage of misoprostol tablet group (106.625 micrograms) was more than that of misoprostol gel group(80.12 micrograms, p = 0.043). Patients required oxytocin augmentation were not different in the two groups (p = 0.141). There was no different in the cesarean section rate or other operative delivery rate among patients in the two treatment groups. (p = 0.169) The apgar score at 1 minutes in the 25 microgram group was greater than 50 micrograms group (9.506 vs 8.313 p = 0.003). The incidence of birth asphyxia in 50 micrograms group was more than in 25 microgram group (p = 0.015). The apgar scores at 5,10 minutes of both newborn groups were not different (p = 0.473,0.319). The incidence of uterine hyperstimulation in 50 micrograms group was more than in 25 microgram group (p = 0.0315).

Conclusion The 25 microgram misoprostol vaginal gel is more effective and safe than 50 microgram vaginal tablet. Because it is not associated with a lower incidence of low apgar score, it is recommended for labor induction in the cases associated with risks of fetal asphysia or distress.