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Clinical trial to compare the use of vaginal misoprostol and transcervical foleys catheter vs misoprostol alone in nulliparous women at 40 weeks for induction of labor

A Randomised Controlled Trial Comparing Transcervical foleys catheter with vaginal misoprostol vs Vaginal misoprostol alone in Nulliparous Pregnant women at 40 weeks. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092977
Enrollment
76
Registered
2025-08-13
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: To compare the use of TCFC along with vaginal misoprostol with vagina misprostol alone in Nulliparous pregnant women at 40 weeks.: All the women participating in the study will receive

Sponsors

Dr Radhakrishnan Government Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Single live intrauterine fetus with cephalic presentation . Period of gestation more than equal to 40 weeks

Exclusion criteria

Exclusion criteria: 1. Modified Bishop score more than equal to 6 2. All contraindications to vaginal delivery .eg carcinoma cervix, structural pelvic abnormalities eg. rachitic pelvis, Cephalopelvic disproportion. 3. Fetal malpresentations. 4. Previous uterine surgery . 5. Multifetal gestation. 6. Antepartum hemorrhage. 7. Intrauterine fetal demise. 8. Allergy to latex. 9. Placenta or vasa previa or cord presentation. 10. Active genital herpes. 11. Contraindications to prostaglandins .eg. Asthma, cardiac disease, known bleeding disorder, concurrent anticoagulant therapy, pelvic infection, hypersensitivity.

Design outcomes

Primary

MeasureTime frame
Induction delivery interval (defined as time of induction with foleys insertion and vaginal misoprostol to delivery of fetus)Timepoint: From the time of insertion of transcervical foleys and misoprostol to delivery of foetus and will be assessed after delivery

Secondary

MeasureTime frame
Proportion of woman delivered vaginallyTimepoint: Within 12 to 24 hours of induction;Proportion of woman undergoing CSTimepoint: After delivery;Meconium stained liquorTimepoint: Not Applicable;Proportion of woman with Failed IOL Neonatal OutcomeTimepoint: If no contractions or Poor Bishop Score after 5 doses of Misoprostol

Countries

India

Contacts

Public ContactDr Sandeep Sharma

Dr Radhakrishnan Medical College

drsharmasandeep81@gmail.com7018179737

Outcome results

None listed

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