Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

Labor Induction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529295
• Other study ID #: DMR95-IRB-116
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2007
• Last updated: September 13, 2007
• Start date: June 2005
• Est. completion date: March 2007

Study information

• Verified date: September 2006
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.

Description:

Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 34 to 42 weeks of gestation

• live singleton

• Bishop score < or = 6

• reassuring fetal heart beat pattern

Exclusion Criteria:

• nonreassuring fetal heart beat pattern

• parity ovr five

• any contraindication to labor and/or vaginal delivery

• uterine scar

• suspected placental abruption with abnormal FHR pattern

• vaginal bleeding other than "bloody show"

• cervical dilatation of > or = 4 cm

• uterine contractions > or = 3 in 10 minutes

• significant maternal cardiac, renal or hepatic disease

• hypersensitivity to misoprostol or prostaglandin analogs

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Labor Induction

Intervention

Drug:
• misoprostol
Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina

Locations

Country	Name	City	State
Taiwan	China Medical University Beigang Hospital	Yun Lin

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Hofmeyr GJ, Alfirevic Z, Matonhodze B, Brocklehurst P, Campbell E, Nikodem VC. Titrated oral misoprostol solution for induction of labour: a multi-centre, randomised trial. BJOG. 2001 Sep;108(9):952-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes.		within the first week after delivery
Secondary	Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.		The days during induction

External Links

•   China Medical University Beigang Hospital