To Study the Efficacy and Safety of Misoprostol by Sublingual Routes for Induction of Labour

• Status: Not yet recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

This research is to compare the efficacy and the safety of sublingual misoprostol with vaginal misoprostol administration for the induction of labour for primigravida at 41 or more weeks of pregnancy. In routine practice, misoprostol 25µg is used by per vaginal route for the induction of labour in Bhutan. The misoprostol dose is given repeatedly every 4 hours to a maximum of 6 dosages. The per vaginal route is found to be very effective and safe for the induction of labour. But, patient compliance is poor and increasing the risk of neonatal sepsis since it has to be inserted into vagina every 4 hours. To overcome these problems with per vaginal route, this study is developed to explore the efficacy and safety of misoprostol use by sublingual routes for the induction of labour. Misoprostol can be used by sublingual, oral or per vaginal route as per the findings of the other studies.

If the finding of this study proves sublingual use of misoprostol is safe and efficient for the induction of labour, the current practice of using misoprostol by vaginal route will be changed to sublingual route in Bhutan.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ministry of Health, Bhutan
• Treatments: Alprostadil; Misoprostol

Criteria

Inclusion Criteria:

• Age 18 or more years

• Primigravida

• Singleton pregnancy

• Gestation at 41 or more weeks of pregnancy

• Estimated fetal weight of <4000 gram

• In cephalic presentation

• Bishop score < 6 (unfavorable cervix)

• Reassuring fetal heart rate tracing

Exclusion Criteria:

• Age <18 years

• Multiple pregnancy (twin, triplet and higher order pregnancies)

• Gestation <41 weeks of pregnancy

• Fetal macrosomia (Estimated fetal weight >4000 gram)

• Cephalo-pelvic disproportion

• Malpresentation (breech, oblique, transverse)

• Bishop score >6 (favorable cervix)

• Presence of labor or uterine contractions

• Non-reassuring fetal heart rate tracing

• Pregnant women with known allergy to misoprostol,

• Previous Caesarean delivery or other uterine surgery

• Previous uterine rupture

• Placenta previa

• Chorioamnionitis

• Prelabour rupture of membrane (PROM)

• Antepartum hemorrhage (per vaginal bleeding)

• Contraindication to vaginal birth

• Medical disorders in pregnancy

• Active genital herpes infection

• Invasive cervical carcinoma