A STUDY FOR COMPARING THE EFFECT OF MIFEPRISTONE WITH MISOPROSTOL FOR INDUCTION OF LABOR

Not yet recruiting

• Conditions: pregnant women for induction of labor

• Registration Number: CTRI/2013/11/004151
• Lead Sponsor: Govt of HP

Brief Summary

100 pregnant women between 37-42 weeks gestation will be recruited after taking their informed consent and fulfilling inclusion and exclusion criteria. 50 women will receive mifepristone 400 mg ( 2tablets, 200 mg each) and will be assessed after 24 & 48 hours, if at any time bishop score is >/= 6 artificial rupture of membranes followed by oxytocin infusion (if required ) will be done, else after 48 hours induction of labor will be started with 25 micrograms of misoprostol each to be repeated four hourly to a maximum of 5 doses in 24 hours, to be followed by artificial rupture of membranes and oxytocin infusion ( if required). Other 50 women will receive placebo tablets (2 tablets of common salt/ NaCl each) and rest all will be done similar as in mifepristone group. These two groups will then be compared for proportion of women in labor after giving mifepristone/placebo, women with normal vaginal delivery, women with cesarean section, women with failed induction, duration of labor, need and amount of oxytocin and neonatal outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-12
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

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

Inclusion Criteria

• Women admitted with indications for induction of labor from gestation 37 to 42 weeks.
• Induction can be postponed for 48 hours.
• Bishop score ≤ 6.
• Singleton pregnancy.
• Vertex presentation.
• Maternal age > 18 years.

Exclusion Criteria

• Bishop score > 6.
• Contraindications to vaginal delivery.
• Oligohydramnios, IUGR.
• Any previous cesarean section or uterine surgery.
• Gravida ≥ 4.
• Multiple pregnancies.
• Severe pre eclampsia.
• Renal failure, adrenal insufficiency, liver failure.
• Patient on corticosteroid treatment.
• Blood clotting disease or on anticoagulant therapy.
• Intrauterine fetal death.
• Any history suggestive of drug allergy.
• Abruptio placentae 15.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of women entering labor after use of mifepristone alone after 24 & 48 hours	time from induction of labor to delivery

Secondary Outcome Measures

Name	Time	Method
•Proportion of women vaginally delivered in each group	•Proportion of women with cesarean section in each group

Trial Locations

Locations (1)

Dr RPGMC Kangra at Tanda (HP); 🇮🇳 Kangra, HIMACHAL PRADESH, India

Dr RPGMC Kangra at Tanda (HP)

🇮🇳Kangra, HIMACHAL PRADESH, India

Dr Chanderdeep Sharma

Principal investigator

9218925471

cdsharma2006@gmail.com