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

This study is currently recruiting participants.
Verified December 2012 by Regenex Pharmaceutical, China
Sponsor:
Information provided by (Responsible Party):
Regenex Pharmaceutical, China
ClinicalTrials.gov Identifier:
NCT01428037
First received: August 31, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cervical Ripening
Induction of Labor
 Drug: Placebo
Drug: Misoprostol vaginal Tablet 25 mcg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Resource links provided by NLM:

Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Regenex Pharmaceutical, China:

Primary Outcome Measures:
  • Treatment success rate [ Time Frame: From the first dose to 12-24 hours ] [ Designated as safety issue: No ]
    Treatment success is defined as: ≧3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours.


Secondary Outcome Measures:
  • Percentage of participants of labor onset within 24 hours [ Time Frame: From the first dose to 24 hours ] [ Designated as safety issue: No ]
  • Time from 1st dose to labor onset [ Time Frame: From the first dose to labor onset ] [ Designated as safety issue: No ]
  • Need for augmentation of labor with oxytocin [ Time Frame: From the first dose to neonate delivery ] [ Designated as safety issue: No ]
  • Rate and reason for Cesarean Section [ Time Frame: From the first dose to neonate delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: March 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428037

Locations
China, Jiangsu
The First Affliated Hospital with Nanjing Meical Uniersity Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Tian Ping Li         jsphkj@163.com    
Zhongda Hospital ,Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Hui Pin Wang         whp57@163.com    
China, Sichuan
Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China, 610072
Contact: Ting Quan         syywjidi@163.com    
China
Southwest Hospital Recruiting
Chongqing, China, 400038
Contact: Yong Chuan Chen         zwmcyc@163.com    
The International Peace Maternity & Child Care of China Welfare Institute Recruiting
Shanghai, China, 200030
Contact: Chuan Liang Tong         tcl_sh@yahoo.cn    
Renji Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 200127
Contact: Wen Di, MD         diwen163@163.com    
Sponsors and Collaborators
Regenex Pharmaceutical, China
Investigators
Principal Investigator: Wen Di, MD RenJi Hospital
  More Information

No publications provided

Responsible Party: Regenex Pharmaceutical, China
ClinicalTrials.gov Identifier: NCT01428037     History of Changes
Other Study ID Numbers: RH-MS-01RCT
Study First Received: August 31, 2011
Last Updated: December 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Regenex Pharmaceutical, China:
Vaginal Misoprostol
Cervical Ripening
Labor Induced

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 21, 2013