To compare Foleys plus PGE2 gel with Foleys plus PGE1 tablet for cervical ripening and induction of labour

A randomized trial to compare intra-cerviacl Foleys catheter combined with intra-cervical dinoprostone or with vaginal misoprostol for pre-induction cervical ripening

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010738

Enrollment

150

Registered

2017-12-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- term patients

Interventions

Intervention1: Foleys catheter plus misoprostol25mcg(pervaginally): foleys catheter produces prostaglandin and misoprostol is a prostaglandin analogue Control Intervention1: Foleys catheter plus dinop

Eligibility

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy with cephalic presentation 2. Gestational age >=34weeks 3. Bishopâ??s score 4. Intact membranes 5. Reactive non-stress test

Exclusion criteria

Exclusion criteria: 1. Uterine scar 2. Antepartum haemorrhage 3. Intrauterine fetal anomaly or death 4. Cervicovaginal infection 5. Heart disease, seizure disorder , severe anaemia, uncontrolled diabetes 6. Severe fetal growth restriction, severe pre-eclampsia 7. Parity >3

Design outcomes

Primary

Measure	Time frame
To determine the induction delivery interval (IDI) with two combined methods used for cervical ripening and IOL a. Foleyâ??s catheter and intracervical dinoprostone gel (0.5mg) b. Foleyâ??s catheter and vaginal. misoprostol (25Âµg Timepoint: 1 year	—

Secondary

Measure	Time frame
To determine the following with the above two methods 1. Change in Bishopâ??s score after 12 hours 2. Caesarean section (CS) rate 3. Uterine contraction abnormalities 4. Infectious morbidity in the mother and the neonate 5. Neonatal outcome Timepoint: 1 year	—

Countries

India

Contacts

Public ContactRahul Garg

Post Graduate Institute of Medical Education & Research,

rashmibagga@gmail.com9872494602

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026