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

NCT01428037 | Completed Phase 3

• 1 other identifier: RH-MS-01RCT
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 6

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.

Conditions

Cervical Ripening; Induction of Labor

Keywords

Vaginal Misoprostol; Cervical Ripening; Labor Induced

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Misoprostol Vagianl Tablet

EXPERIMENTAL

Misoprostol Vaginal Tablet 25 mcg.

Drug: Misoprostol vaginal Tablet 25 mcg

Placebo

PLACEBO COMPARATOR

Tablet without active ingredient

Drug: Placebo

Interventions

Placebo DRUG

One tablet vaginal inserted at 4 hrly interval with maximum of three doses

Placebo

Misoprostol vaginal Tablet 25 mcg DRUG

One tablet vaginal insert at 4 hrly interval with maximum of three doses

Also known as: Misoprostol vaginal Tablet

Misoprostol Vagianl Tablet

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenex Pharmaceutical, China: lead

Study Sites (6)

Zhongda Hospital ,Southeast University

Nanjing, Jiangsu, 210009, China

Location

The First Affliated Hospital with Nanjing Meical Uniersity

Nanjing, Jiangsu, 210029, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Southwest Hospital

Chongqing, 400038, China

Location

The International Peace Maternity & Child Care of China Welfare Institute

Shanghai, 200030, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

Location

Study Officials

• Wen Di, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

CN (6)