Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter

Kazakhstan's Medical University "KSPH"

Status and phase

Completed

Phase 4

Conditions

Induction of Labor

Treatments

Drug: Misoprostol 200mcg Tab

Device: Foley Catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT06056141

IRB-23-2023

Details and patient eligibility

About

Comparison of efficacy and safety of low-dose oral Misoprostol versus folley catheter for preinduction in women with an immature cervix at term.

Full description

Open-label randomised trial in 2 hospitals in the Almaty,Kazakhstan. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section will be randomly allocated to 2 groups: 1 group -cervical ripening with 25 μg oral misoprostol once every 2 hour, 2 nd group- a 30 mL transcervical Foley catheter. The primary outcome will be vaginal delivery within 24 hours(to evaluate effectiveness) and secondary outcoms 1-5-min Apgar score and hospitalization in ICU, hyperstimulation frequency and hemorrage (for evaluating safety)

Enrollment

300 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

women with an unfavourable cervix who will scheduled for induction of labour

Exclusion criteria

Women with previous caesarean sections unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioamnionitis All cases when physiological childbirth is impossible (placenta previa,transverse position of the fetus )