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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Cervical Ripening; Labor Induction

Treatments: Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00886860

091/2552(EC2)

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

conventional oral misoprostol

Active Comparator group

Description:

misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters

Treatment:

Drug: misoprostol

Drug: misoprostol

titrated oral misoprostol

Experimental group

Description:

misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters

Treatment:

Drug: misoprostol

Drug: misoprostol