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Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

NCT ID: NCT00529295

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Labor Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Titrated oral misoprostol

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

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

2

Vaginal misoprostol

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Shi-Yann Cheng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinal Medical University Beigang Hospital

Locations

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China Medical University Beigang Hospital

Douliu, , Taiwan

Site Status

Countries

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Taiwan

References

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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. doi: 10.1111/j.1471-0528.2001.00231.x.

Reference Type RESULT
PMID: 11563466 (View on PubMed)

Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.

Reference Type DERIVED
PMID: 34155622 (View on PubMed)

Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71.

Reference Type DERIVED
PMID: 18165400 (View on PubMed)

Other Identifiers

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DMR95-IRB-116

Identifier Type: -

Identifier Source: org_study_id