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This is a study to compare the outcome of inducing labor by using a tube inserted in cervix along with misoprostol medication either as oral solution or as tablet kept under your tongue among women in their first pregnancy at term gestation requiring induction of labor

Comparison of outcome of labor induction by combination of Foleys catheter with either titrated oral misoprostol solution or sublingual misoprostol among nulliparous women at term - A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070403
Enrollment
304
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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: Oral misoprostol solution: 22F Foley’s catheter will be introduced intracervically under aseptic precautions such that the bulb of the catheter lies over the internal os. The bulb will
in the absence of adequate uterine contractions, the dose will be increased to 30 mcg hourly for three doses followed by 40 mcg for one dose, at an interval of 1.5 h, and 50 mcg for one dose. If the f

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Nulliparous women = 18 years of age 2)Gestational age = 37 weeks 3)Singleton pregnancy, vertex presentation 4)Bishop’s score less than or equal to 4

Exclusion criteria

Exclusion criteria: 1)Women with severe pre-eclampsia 2)Premature rupture of membranes 3)Previously scarred uterus (myomectomy/ septal resection) 4)Previous anaphylaxis to prostaglandins 5)Abnormal FHR changes

Design outcomes

Primary

MeasureTime frame
Proportion of successful vaginal deliveryTimepoint: 72 hours after insertion of foleys catheter

Secondary

MeasureTime frame
Maternal & fetal outcomeTimepoint: 72 hours after insertion of foleys catheter;Time from induction to deliveryTimepoint: 72 hours after insertion of foleys catheter

Countries

India

Contacts

Public ContactLakshanya

Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry

jipoghod@gmail.com9486008274

Outcome results

None listed

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