Oral Misoprostol Solution in Labor Induction

Labour,Induced Clinical Trial

Official title:

A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03927807
• Other study ID #: misoprostol in induction
• Status: Recruiting
• Phase: Phase 2
• Start date: March 18, 2019
• Est. completion date: January 18, 2020

Study information

• Verified date: April 2019
• Source: Ain Shams University
• Contact: essam sa hagag, MBBCh
• Phone: 01066813830
• Email: essamhagag742[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 18, 2020
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labour,Induced

Intervention

Drug:
• Misoprostol
This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Cairo Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

27986461

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mode of delivery	Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.	24 hours from the first dose of induction till delivery
Secondary	Adverse maternal outcomes	As uterine hyper stimulation,fever,vomiting,shivering,nausea	in 24 hours
Secondary	Adverse neonatal outcomes	As neonatal intensive care unit admission,non reassuring fetal heart rate	24 hours post partum