Induction of Labor Clinical Trial
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
Verified date | November 2013 |
Source | Regenex Pharmaceutical, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
Status | Completed |
Enrollment | 225 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Sichuan Provincial People's Hospital | Chengdu | Sichuan |
China | Southwest Hospital | Chongqing | |
China | The First Affliated Hospital with Nanjing Meical Uniersity | Nanjing | Jiangsu |
China | Zhongda Hospital ,Southeast University | Nanjing | Jiangsu |
China | Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | |
China | The International Peace Maternity & Child Care of China Welfare Institute | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Regenex Pharmaceutical, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Percentage of participants of labor onset within 24 hours | From the first dose to 24 hours | No | |
Secondary | Time from 1st dose to labor onset | From the first dose to labor onset | No | |
Secondary | Need for augmentation of labor with oxytocin | From the first dose to neonate delivery | No | |
Secondary | Rate and reason for Cesarean Section | From the first dose to neonate delivery | No |
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