Clinical trial NCT01428037: Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Ripening
Induction of Labor
Keywords: Vaginal Misoprostol
Cervical Ripening
Labor Induced
Lead sponsor: Regenex Pharmaceutical, China
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 225
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment success rate
timeFrame: From the first dose to 12-24 hours
Secondary outcomes:
measure: Percentage of participants of labor onset within 24 hours
timeFrame: From the first dose to 24 hours
measure: Time from 1st dose to labor onset
timeFrame: From the first dose to labor onset
measure: Need for augmentation of labor with oxytocin
timeFrame: From the first dose to neonate delivery
measure: Rate and reason for Cesarean Section
timeFrame: From the first dose to neonate delivery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital ,Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: The First Affliated Hospital with Nanjing Meical Uniersity
state: Jiangsu
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chongqing
country: China
facility: Southwest Hospital
city: Shanghai
country: China
facility: The International Peace Maternity & Child Care of China Welfare Institute
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: RenJi Hospital
name: Wen Di, MD
role: PRINCIPAL_INVESTIGATOR
References: