Comparison of safety and efficacy of chemical method vs mechanical method in inducing labour pains in a term pregnant mother

Phase 2/3

Not yet recruiting

• Conditions: Pregnant term mothers

• Registration Number: CTRI/2020/08/027093
• Lead Sponsor: Dr Maya menon

Brief Summary

This study is a randomized double blind parallel group controlled trial comparing the efficacy and safety of intracervical Foley’s catheter balloon vs intracervical prostaglandin E2 gel in cervical ripening for induction of labour in term antenatal mother’s with unfavourable cervix conducted in 100 patients in Department of Obstetrics and Gynaecology , ESIC medical college and PGIMSR , kk Nagar , Chennai. The primary outcome measures are post induction changes in Bishop’s score. The secondary outcomes are mean induction to delivery interval, mode of delivery and maternal and feta outcomes.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-31
• Study Start: 2020-08-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Primigravida, more than 37weeks gestation, singleton pregnancy, cephalic presentation, bishops score less than 5, intact membranes, reactive preinduction CTG.

Exclusion Criteria

Multiple pregnancy, malpresentation, absent membranes, antepartum hemorrhage, previous uterine scar, active genital infections, major CPD, Medical conditions like heart disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post induction bishops score	12 hours

Secondary Outcome Measures

Name	Time	Method
Mean induction to delivery interval	Mode of delivery

Trial Locations

Locations (1)

ESIC Medical college and PGIMSR; 🇮🇳 Chennai, TAMIL NADU, India

ESIC Medical college and PGIMSR

🇮🇳Chennai, TAMIL NADU, India

Anjani Devi S

Principal investigator

09840349617

anjanisubramanian1@gmail.com