Oral Misoprostol Solution in Labor Induction

Phase 2

• Conditions: Labour,Induced
• Interventions: Drug: Misoprostol

• Registration Number: NCT03927807
• Lead Sponsor: Ain Shams University

Brief Summary

This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

Detailed Description

Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

Study Timeline

• Study Start: 2019-03-18
• Status Verified: 2019-04
• Study First Submitted: 2019-04-20
• Study First Submitted QC: 2019-04-23
• Last Update Submitted: 2019-04-23
• Study First Posted: 2019-04-25
• Last Update Posted: 2019-04-25
• Primary Completion: 2019-12-18
• Study Completion: 2020-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Nulliparas
• Term pregnancy(equal or more than 37 wks)
• Bishop score <6
• Cephalic presentation
• reassuring fetal heart rate pattern
• Not in labor ( no uterine contractions)
• Clinically adequate pelvis
• Singleton live pregnancy

Exclusion Criteria

• Allergic to misoprostol or prostaglandin analogues
• Previous uterine scar( cesarean section,hysterotomy,myomectomy)
• Multiple fetal gestations
• Fetal demise
• Preterm labor
• Malpresentations
• Non reactive cardiotocography at admission
• Cephalo pelvic disproportion
• Fetal macrosomia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
two hourly dose of oral misoprostol	Misoprostol	The dose will be 20 microgram oral misoprostol solution that will be administered every 2 hours up to 6 doses or till onset of regular uterine activity.
repetitive hourly dose of oral misoprostol	Misoprostol	The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity.

Primary Outcome Measures

Name	Time	Method
Mode of delivery	24 hours from the first dose of induction till delivery	Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.

Secondary Outcome Measures

Name	Time	Method
Adverse neonatal outcomes	24 hours post partum	As neonatal intensive care unit admission,non reassuring fetal heart rate
Adverse maternal outcomes	in 24 hours	As uterine hyper stimulation,fever,vomiting,shivering,nausea

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Cairo Governorate, Egypt