Induction of Labor in Term Pregnancies With Unfavourable Cervix (RAND)

Clinical Hospital Merkur

Status and phase

Completed

Phase 4

Conditions

Induction of Labor Affected Fetus / Newborn

Prostaglandins Causing Adverse Effects in Therapeutic Use

Treatments

Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly

Drug: Dinoprostone 0.5 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT04280874

RANDOM1

Details and patient eligibility

About

This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.

Full description

This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.

Enrollment

212 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

term pregnancies (> 37 weeks gestation)
unfavourable cervix (Bishop score <6)
indication for labor induction
absence of uterine contractions
reassuring cardiotocography

Exclusion criteria

ruptured membranes
scar uterus (previous caesarean section or uterus surgery)
pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation