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A study to find out if giving Mifepristone before Prostaglandins helps start labour earlier than using Prostaglandins alone in full-term pregnant women.

A Prospective, Parallel-group, Double Blinded Randomized Controlled Trial to Compare the Safety and Efficacy of Sequential Oral Mifepristone and Prostaglandins Versus Prostaglandins alone for Induction of Labor in women with Singleton Term Live Pregnancies - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092713
Enrollment
208
Registered
2025-08-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Parallel group 1: Oral Mifepristone followed by Dinoprostone gel: Oral Mifepristone (200 mg, 2 doses 24 hours apart). After 12hours of 2nd Dose of Mifepristone. give Dinoprostone gel (D

Sponsors

Holy Family Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Singleton, term, live pregnancies with a cephalic presentation and a cervical Bishop score of less than 6 were included 2.Induction could be deferred for 48 hrs 3.Intact Membranes 4.Confirmed Gestational age of 37 weeks or more (term pregnancy) 5.Ability to provide informed consent

Exclusion criteria

Exclusion criteria: 1.Any mother who needs more than one type of prostaglandins, i.e requiring both Dinoprostone gel and Misoprostol oral tablets. 2.Malpresentation 3.Previous Caesarean 4.Multiple Pregnancies 5.Placenta Previa 6.Intrauterine death of Fetus 7.Any mother who is not eligible for trial of vaginal delivery

Design outcomes

Primary

MeasureTime frame
Comparison of Induction to-onset of labour and Comparison of Induction to-delivery interval interval in the different groups Timepoint: 1st, 2nd, 3rd year

Secondary

MeasureTime frame
Comparison of improvement in Bishop scores at 48 hours in different groupsTimepoint: 48 hours;Comparison of modes of delivery in the different groupsTimepoint: 5 days;Comparison of duration of oxytocin augmentation in the different groupsTimepoint: 5 days;Rate of failed induction in the different groupsTimepoint: 5 days;To compare maternal morbidity in different groupsTimepoint: 5 days;To compare neonatal morbidity in different groups defined belowTimepoint: 7 days

Countries

India

Contacts

Public ContactDr Arpita De

Holy Family Hospital

arpitade07@gmail.com09899864949

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026