The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Cervical Ripening Clinical Trial

Official title:

The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886860
• Other study ID #: 091/2552(EC2)
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2009
• Last updated: July 12, 2010
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age 18 years old or more

• singleton pregnancy at 37 weeks gestation or more

• cephalic presentation

• reassuring fetal heart rate pattern

• admission for labor induction due to medical or obstetrical conditions

• bishop score less than 6

• giving consent and having signed the consent form for this study

Exclusion Criteria:

• parity more than 3

• estimated fetal weight more than 3,500 grams

• non-reassuring fetal heart rate pattern

• having contraindication for vaginal delivery

• previous uterine scar

• suspected abruptio placenta with non-reassuring fetal heart rate pattern

• abnormal bleeding per vagina, except bloody show

• PROM

• having underlying cardiac, hepatic, or renal diseases

• having history of allergy to misoprostol or prostaglandin analogues

• cervical dilatation 3 centimeters or more

• uterine contraction 3 times or more in 10 minute

Study Design

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

Related Conditions & MeSH terms

• Cervical Ripening
• Labor Induction

Intervention

Drug:
• misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
• misoprostol
misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm

Locations

Country	Name	City	State
Thailand	Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of cervical ripening in labor induction		12 hours after intervention	Yes
Secondary	number of vaginal delivery		24 hours	Yes