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A clinical trail to study the efficacy and safety of two dose regimens of misoprostol for labor induction

Labour induction with intravaginal misprostol; comparision of 25 micrograms vs 50 micrograms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000115
Enrollment
100
Registered
2008-08-14
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- labor induction

Interventions

Intervention1: Misoprostol: Single 50 micrograms versus multiple 25 micrograms Intervention2: misoprostol: 50 micrograms single dose Control Intervention1: misoprostol: 25 micrograms every 6 hours for

Sponsors

Kasturba Medical College
Lead Sponsor
Dr TMA Pai Rotary Hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: inclusion criteria 1. Women with singleton pregnancy 2. Past date pregnancy of 40 weeks or more 3. At term (between 37 and 42 completed weeks of pregnancy) 4. Cephalic presentation 5. Bishop score 6. Amniotic fluid index > 5 7. Reactive fetal heart rate pattern 8. Membranes could be intact or ruptured

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows 1. Parity >3 2. Prior uterine scars ( previous cesarean section and myomectomy) 3. Multiple pregnancy 4. Estimated fetal weight > 4500 or < 2000g 5. Abnormal fetal heart rate tracings on non stress test 6. Placenta previa 7. Hypersensitivity to prostaglandins 8. Renal, hepatic or cardiovascular disease 9. Severe asthma

Design outcomes

Primary

MeasureTime frame
vaginal delivery within 24 hours of induction with misoprostolTimepoint: A primary outcome measure is the interval from the first dose of misoprostol to vaginal delivery.

Secondary

MeasureTime frame
Change in the Bishop score Time interval from induction to onset of adequate uterine contractions Number of women delivering within 12 hours of induction Mode of delivery,spontaneous vaginal, instrumental delivery or Cesarean section and indications for the same Number of doses of misoprostol used Oxytocin augmentation Incidence of adverse effects: hyperstimulaton, fetal heart rate abnormalities. Incidence of postpartum hemorrhage, Neonatal outcome and patient satisfactionTimepoint: Maternal and neonatal outcome

Countries

India

Contacts

Public ContactManjunath A P

Kasturba Medical College. Manipal University

manjunathattibele@gmail.com00918202922211

Outcome results

None listed

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