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Comparing drug versus drug with catheter in low risk first time pregnant mothers for labor induction

Misoprostol with Foleys catheter versus Misoprostol alone for induction of labor in term primigravidas - a prospective randomized coitrol trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015553
Enrollment
608
Registered
2018-08-31
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- Pregnant women who are planned for induction of labor

Interventions

Intervention1: Misoprostol: PV PGE1 Q4h for 3 doses Control Intervention1: misoprostol with foleys: Misoprostol versus misoprostol with foleys comparing term primi gravida whether interval to delivery

Sponsors

CMC vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Primigravida 2 37 completed weeks to 40+6 weeks of gestation 3 Low risk pregnancy 4 Singleton, cephalic presentation, live fetes 5 Intact membranes 6 Bishops Score • Reactuve preinduction CTG

Exclusion criteria

Exclusion criteria: 1 Multigravida 2 Bishops Score >6 3 High Risk Pregnancy 4 Rupture of membranes 5 Maternal fever 6 Non vertex presentation 7 Non reassuring CTG 8 Reinduction (previously unsuccessful induction of labour) 9 Allergy to Misoprostol/ latex 10 Previous LSCS/myomectomy

Design outcomes

Primary

MeasureTime frame
Induction to delivery intervalTimepoint: once

Secondary

MeasureTime frame
Rate of vaginal delivery Rate of primary LSCS Incidence of Meconium stained liquor Uterine tachysystole with CTG changes Endomyometritis Need for Terbutaline Chorioamnionitis Asphyxia (Cord pH , 7.2, low APGAR 5 and 7 ) Atonic PPH NICU admission Endomyometritis Timepoint: All these outcomes will be assessed at the time of delivery and upto 6 weeks post partum

Countries

India

Contacts

Public ContactDr Jessie Lionel

CMC Vellore

jessielionel@cmcvellore.ac.in9566804173

Outcome results

None listed

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