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Comparison of the effectiveness of 2 cervical ripening agents Oral Mifepristone and vaginal Isosorbide Mononitrate (IMN) for induction of labor in pregnant women with gestational age 28 to 34 weeks.

A Comparative study to determine effectiveness of Mifepristone and Isosorbide Mononitrate(IMN) as cervical ripening agents for induction of labor in pregnant women with gestational age 28 to 34 weeks.

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053401
Enrollment
100
Registered
2023-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: O619- Failed induction of labor, unspecified

Interventions

Intervention1: Oral tab. Mifepristone: 200mg oral tab. Mifepristone single dose,oral route Intervention2: vaginal Isosorbide Mononitrate IMN: 40mg vaginal Isosorbide Mononitrate IMN,2doses at 6hrs int

Sponsors

Dr Meeta Pandit
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All 28 to 34 weeks pregnancy who need Induction of labor for obstetrics and maternal indications. 2.Bishops score less than 4. 3.Those giving consent.

Exclusion criteria

Exclusion criteria: 1.Contraindications to vaginal birth. 2.Hypersensitivity to Mifepristone and IMN. 3.Contraindications to Mifepristone and IMN. 4.Those not giving consent.

Design outcomes

Primary

MeasureTime frame
Improvement in Bishops Score Duration between administration of cervical ripening agents and delivery Failed induction is after 2 doses of misoprostol 3hrs apart Timepoint: at baseline after 6hrs after 12hrs at 15 hrs at 18 hrs

Secondary

MeasureTime frame
Mode of deliveryTimepoint: Failed induction is after 2 doses of misoprostol 3h apart

Countries

India

Contacts

Public ContactDr Professor Anupama Dave

MGM Medical College Indore

anupamadave10@gmail.com9425053230

Outcome results

None listed

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