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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01428037
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):
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.

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

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  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

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 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

Primary Outcome Measures :
  1. Treatment success rate [ Time Frame: 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 :
  1. Percentage of participants of labor onset within 24 hours [ Time Frame: From the first dose to 24 hours ]
  2. Time from 1st dose to labor onset [ Time Frame: From the first dose to labor onset ]
  3. Need for augmentation of labor with oxytocin [ Time Frame: From the first dose to neonate delivery ]
  4. Rate and reason for Cesarean Section [ Time Frame: From the first dose to neonate delivery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01428037

China, Jiangsu
Zhongda Hospital ,Southeast University
Nanjing, Jiangsu, China, 210009
The First Affliated Hospital with Nanjing Meical Uniersity
Nanjing, Jiangsu, China, 210029
China, Sichuan
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Southwest Hospital
Chongqing, China, 400038
The International Peace Maternity & Child Care of China Welfare Institute
Shanghai, China, 200030
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200127
Sponsors and Collaborators
Regenex Pharmaceutical, China
Principal Investigator: Wen Di, MD RenJi Hospital

Responsible Party: Regenex Pharmaceutical, China Identifier: NCT01428037     History of Changes
Other Study ID Numbers: RH-MS-01RCT
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

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

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents