Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
NCT ID: NCT01428037
Last Updated: 2013-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2012-03-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Misoprostol Vagianl Tablet
Misoprostol Vaginal Tablet 25 mcg.
Misoprostol vaginal Tablet 25 mcg
One tablet vaginal insert at 4 hrly interval with maximum of three doses
Placebo
Tablet without active ingredient
Placebo
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
Interventions
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Placebo
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
Misoprostol vaginal Tablet 25 mcg
One tablet vaginal insert at 4 hrly interval with maximum of three doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
FEMALE
No
Sponsors
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Regenex Pharmaceutical, China
OTHER
Responsible Party
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Principal Investigators
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Wen Di, MD
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
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Zhongda Hospital ,Southeast University
Nanjing, Jiangsu, China
The First Affliated Hospital with Nanjing Meical Uniersity
Nanjing, Jiangsu, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Southwest Hospital
Chongqing, , China
The International Peace Maternity & Child Care of China Welfare Institute
Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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Other Identifiers
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RH-MS-01RCT
Identifier Type: -
Identifier Source: org_study_id