Status:
COMPLETED
Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
Lead Sponsor:
Regenex Pharmaceutical, China
Conditions:
Cervical Ripening
Induction of Labor
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
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.
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: sensitizati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01428037
Start Date
March 1 2012
End Date
January 1 2013
Last Update
November 25 2013
Active Locations (6)
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1
Zhongda Hospital ,Southeast University
Nanjing, Jiangsu, China, 210009
2
The First Affliated Hospital with Nanjing Meical Uniersity
Nanjing, Jiangsu, China, 210029
3
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
4
Southwest Hospital
Chongqing, China, 400038