Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Study Overview
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Brief Summary
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The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.

Detailed Description
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There are many pregnant women require medical intervention to induce labor for some reasons at term. There are two fundamental changes that characterize pre-labor preparation for delivery: sensitization of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of these changes. Low dose misoprostol is effective and safe for labor induction and has been used widely. Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex Corporation has developed a vaginal tablet with 25mcg misoprostol. The primary objective of the study was to assess of the efficacy and safety of low dose (25 mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.

Official Title
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A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Conditions
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Cervical Ripening, Induction of Labor

Intervention / Treatment
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* Drug: Placebo
* Drug: Misoprostol vaginal Tablet 25 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy. Aged 20 years or older. At term (37 to 42 weeks inclusive gestation). Cephalic presentation (normal lie). No rupture. Bishop score ≤6. With an indication for labour induction. Written informed consent. Exclusion Criteria: Any contraindication to vaginal delivery. Previous of uterine scar(Cesarean section or other uterine surgeries). Heavy or repeated vaginal bleeding in third trimester of pregnancy. Have a history of glaucoma,asthma or epilepsy. Contraindication to prostaglandin use. Known severe allergy to prostaglandin. Placenta previa Premature rupture of membranes Placental abruption Fetal malpresentation(Breech or Transverse) Obvious cephalopelvic disproportion Amniotic Fluid Index more than 250mm or less than 50mm Fetal growth restriction Fetal malformation Fetal distress Preeclampsia or eclampsia Fetal macrosomia of prenatal diagnosis(B-type ultrasonic inspection/Abdomen estimates) Intrahepatic cholestasis syndrome(ICP) Pregnancy with severe heart, lung, liver, kidney, endocrine disease and immune dysfunction Pregnancy with acute systemic infection Pregnancy with Severe anemia Cervical carcinoma Some genital tract infection disease, such as active herpes infection Take part in other clinical trials within three months. The person that investigator thought not be enrolled.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol Vagianl Tablet<br>Misoprostol Vaginal Tablet 25 mcg. | Drug: Misoprostol vaginal Tablet 25 mcg<br>* One tablet vaginal insert at 4 hrly interval with maximum of three doses<br>* Other names: Misoprostol vaginal Tablet;|
| Placebo Comparator: Placebo<br>Tablet without active ingredient | Drug: Placebo<br>* One tablet vaginal inserted at 4 hrly interval with maximum of three doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success rate | Treatment success is defined as: ≧3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours. | From the first dose to 12-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants of labor onset within 24 hours |  | From the first dose to 24 hours | 
| Time from 1st dose to labor onset |  | From the first dose to labor onset | 
| Need for augmentation of labor with oxytocin |  | From the first dose to neonate delivery | 
| Rate and reason for Cesarean Section |  | From the first dose to neonate delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal Misoprostol, Cervical Ripening, Labor Induced