The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
225
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
One tablet vaginal insert at 4 hrly interval with maximum of three doses
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
Treatment success rate
Treatment success is defined as: ≧3 of Bishop score increased within 12 hours or Vaginal delivery within 24 hours.
Time frame: From the first dose to 12-24 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
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The International Peace Maternity & Child Care of China Welfare Institute
Shanghai, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China