Oral Misoprostol Solution in Labor Induction

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Labour,Induced

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: repetitive hourly dose of oral misoprostol<br>The dose will be 10 microgram oral misoprostol that will be administered hourly up to 12 doses or till onset of regular uterine activity. | Drug: Misoprostol<br>* 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.<br>|
| Experimental: two hourly dose of oral misoprostol<br>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. | Drug: Misoprostol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse maternal outcomes | As uterine hyper stimulation,fever,vomiting,shivering,nausea | in 24 hours | 
| Adverse neonatal outcomes | As neonatal intensive care unit admission,non reassuring fetal heart rate | 24 hours post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol