Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term - Full Text View

Sponsored by:	China Medical University Hospital
Information provided by:	China Medical University Hospital
ClinicalTrials.gov Identifier:	NCT00529295

Purpose

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.

Condition	Intervention	Phase
Labor Induction	Drug: misoprostol	Phase III

Drug Information available for: Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:

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. [ Time Frame: within the first week after delivery ]

Secondary Outcome Measures:

Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure. [ Time Frame: The days during induction ]

Enrollment:	220
Study Start Date:	June 2005
Study Completion Date:	March 2007

Arms	Assigned Interventions
1: Experimental Titrated oral misoprostol	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
2: Active Comparator Vaginal misoprostol	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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529295

Locations

Taiwan
China Medical University Beigang Hospital
Yun Lin, Taiwan, 651

Sponsors and Collaborators

China Medical University Hospital

Investigators

Principal Investigator:

Shi-Yann Cheng, M.D.

Chinal Medical University Beigang Hospital

More Information

China Medical University Hospital This link exits the ClinicalTrials.gov site

China Medical University Beigang Hospital This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Publications indexed to this study:

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.

Study ID Numbers:	DMR95-IRB-116
Study First Received:	September 13, 2007
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00529295
Health Authority:	Taiwan: Department of Health

Keywords provided by China Medical University Hospital:

misoprostol
labor induction

Study placed in the following topic categories:

Misoprostol

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009