Oral Misoprostol Solution in Labor Induction

Ain Shams University

Status and phase: Unknown; Phase 2

Conditions: Labour,Induced

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03927807

misoprostol in induction

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

repetitive hourly dose of oral misoprostol

Experimental group

Description:

The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity.

Treatment:

Drug: Misoprostol

two hourly dose of oral misoprostol

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol