Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428037
• Other study ID #: RH-MS-01RCT
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2011
• Last updated: November 21, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Induction of Labor

Intervention

Drug:
• Placebo
One tablet vaginal inserted at 4 hrly interval with maximum of three doses
• Misoprostol vaginal Tablet 25 mcg
One tablet vaginal insert at 4 hrly interval with maximum of three doses

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Regenex Pharmaceutical, China

Country where clinical trial is conducted

China, 

Outcome

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