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

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

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

Study Overview

• Status: Completed
• Conditions: Induction of Labor; Cervical Ripening
• Intervention / Treatment: Drug: Misoprostol vaginal Tablet 25 mcg; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing, China, 400038
    • Southwest Hospital
  • Shanghai, China, 200127
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200030
    • The International Peace Maternity & Child Care of China Welfare Institute
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital ,Southeast University
    • Nanjing, Jiangsu, China, 210029
      • The First Affliated Hospital with Nanjing Meical Uniersity
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Regenex Pharmaceutical, China
• Investigators: Principal Investigator: Wen Di, MD, RenJi Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 1, 2011
• First Posted (Estimate): September 2, 2011

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 21, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Cervical Ripening; Vaginal Misoprostol; Labor Induced
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: RH-MS-01RCT