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

Phase 3

Completed

• Conditions: Cervical Ripening; Induction of Labor
• Interventions: Drug: Misoprostol vaginal Tablet 25 mcg; Drug: Placebo

• Registration Number: NCT01428037
• Lead Sponsor: Regenex Pharmaceutical, China

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Study Start: 2012-03
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol Vagianl Tablet	Misoprostol vaginal Tablet 25 mcg	Misoprostol Vaginal Tablet 25 mcg.
Placebo	Placebo	Tablet without active ingredient

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Zhongda Hospital ,Southeast University; 🇨🇳 Nanjing, Jiangsu, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China

The First Affliated Hospital with Nanjing Meical Uniersity; 🇨🇳 Nanjing, Jiangsu, China

The International Peace Maternity & Child Care of China Welfare Institute; 🇨🇳 Shanghai, China

Southwest Hospital; 🇨🇳 Chongqing, China

Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China