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.

Phase 2/3

Recruiting

• Conditions: Pregnant women with 28 to 34 weeks gestational age who need termination of pregnancy; Failed induction of labor, unspecified,

• Registration Number: CTRI/2023/06/053401
• Lead Sponsor: Dr Meeta Pandit

Brief Summary

This study is a randomized control open label parallel group trial comparing the effectiveness of oral Mifepristone and vaginal Isosorbide Mononitrate IMN as cervical ripening agents for induction of labor in pregnant women of gestational age 28 to 34 weeks,for 12months in 100 pregnant women who need induction of labor for various obstetric and maternal indications, conducted at one center in India. The outcome will be assessed based on improvement in Bishops Score and  duration between administration of cervical ripening agent and delivery.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-06
• Last Update Posted: 2023-11-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Bishops Score	at baseline | after 6hrs | after 12hrs | at 15 hrs | at 18 hrs
Duration between administration of cervical ripening agents and delivery	at baseline | after 6hrs | after 12hrs | at 15 hrs | at 18 hrs
Failed induction is after 2 doses of misoprostol 3hrs apart	at baseline | after 6hrs | after 12hrs | at 15 hrs | at 18 hrs

Secondary Outcome Measures

Name	Time	Method
Mode of delivery	Failed induction is after 2 doses of misoprostol 3h apart

Trial Locations

Locations (1)

MGM Medical College and M Y Hospital; 🇮🇳 Indore, MADHYA PRADESH, India

MGM Medical College and M Y Hospital

🇮🇳Indore, MADHYA PRADESH, India

Dr Meeta Pandit

Principal investigator

9827654118

meetapandit26@gmail.com