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A randomized controlled trial of induction of labour by Foley balloon inflation to 60 ml with sublingual misoprostol

Randomized controlled trial of induction of labour comparing Foley balloon inflation to 60 ml with sublingual misoprostol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/08/001969
Enrollment
304
Registered
2011-08-26
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- Induction of labour with low preinduction Bishop score

Interventions

Intervention1: labour: Foley balloon, misoprostol Intervention2: misoprostol: Induction of labour by administration of 25 microgram sublingual misoprostol at 4 hour interval - maximum 6 doses Contro

Sponsors

BS Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Live singletone pregnancy with gestational age 36 weeks or more with medical or obstetric indication for induction Both nulliparous and multiparous women Cephalic presentation Unfavourable cervix (Bishop score6) Reassuring fetal heart tracing

Exclusion criteria

Exclusion criteria: Rupture of membranes Multiple gestation Presentation other than cephalic Prior caesarean delivery Known contraindication to prostaglandin Grand multiparous mother

Design outcomes

Primary

MeasureTime frame
Percentage of women delivered vaginally within 24 hoursTimepoint: Percentage of women delivered vaginally within 24 hours—

Secondary

MeasureTime frame
Induction to delivery interval Number of unsuccessful induction Number of caesarean or operative vaginal delivery Neonatal morbidity Time to active labourTimepoint: 24 hours—

Countries

India

Contacts

Public ContactGourisankar Kamilya

B.S. Medical College, Bankura

drgkamilya@gmail.com09433122643

Outcome results

None listed

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