Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
|Cervical Ripening Induction of Labor||Drug: Placebo Drug: Misoprostol vaginal Tablet 25 mcg||Phase 3|
|Study Design:||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|
- 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.
- Percentage of participants of labor onset within 24 hours [ Time Frame: From the first dose to 24 hours ]
- Time from 1st dose to labor onset [ Time Frame: From the first dose to labor onset ]
- Need for augmentation of labor with oxytocin [ Time Frame: From the first dose to neonate delivery ]
- Rate and reason for Cesarean Section [ Time Frame: From the first dose to neonate delivery ]
|Study Start Date:||March 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428037
|Zhongda Hospital ,Southeast University|
|Nanjing, Jiangsu, China, 210009|
|The First Affliated Hospital with Nanjing Meical Uniersity|
|Nanjing, Jiangsu, China, 210029|
|Sichuan Provincial People's Hospital|
|Chengdu, Sichuan, China, 610072|
|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|
|Principal Investigator:||Wen Di, MD||RenJi Hospital|