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Vaginal misoprostol compared to sublingual misoprostol in initiation of labor pain in primigravidae with single foetus with premature rupture of membranes at gestational age of 36 weeks or later-A Randomized control trial

Vaginal misoprostol compared to sublingual misoprostol in induction of labor in singleton primigravidae with premature rupture of membranes at gestational age of 36 weeks or later-A Double blinded, Randomized control, Superiority trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098242
Enrollment
290
Registered
2025-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: -

Interventions

Intervention1: Vaginal Misoprostol: Group 1 will recieve Vaginal misoprostol 25mcg, every 4th hourly-Upto 4 doses Control Intervention1: sublingual misoprostol: Group 2 will recieve T. misoprostol 25

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.More than 18years of age 2.Bishop score of less than or equal to 4 3.Unscarred uterus

Exclusion criteria

Exclusion criteria: 1.BMI >40 2.Allergic to prostaglandin 3.Antepartum haemorrhage 4.Foetal distress before induction process as revealed by Non stress test 5.Cephalo pelvic disproportion(CPD) 6.Meconium stained liquour at admission

Design outcomes

Primary

MeasureTime frame
Reduction in rate of caesarean section by Vaginal misoprostol compared to sublingual misoprostolTimepoint: The outcome will be assessed from the time of Induction till delivery of foetus.No postnatal follow up performed.Baseline details during delivery are recorded

Secondary

MeasureTime frame
1)Maternal & perinatal outcomes which includes uterine hyperstimulation,foetal distress,meconium stained liquor,NICU admission. 2.Induction to delivery intervalTimepoint: All the outcomes will be assessed from the time of Induction till Delivery of the Foetus baseline parameters noted.No follow up is done post delivery

Countries

India

Contacts

Public ContactDr Latha Chaturvedula

JIPMER

jipoghod@gmail.com9486008274

Outcome results

None listed

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