Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

NCT00529295 | Completed Phase 3

• 1 other identifier: DMR95-IRB-116
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Induction

Keywords

misoprostol; labor induction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.

  The days during induction

Study Arms (2)

1

EXPERIMENTAL

Titrated oral misoprostol

Drug: misoprostol

2

ACTIVE COMPARATOR

Vaginal misoprostol

Drug: misoprostol

Interventions

misoprostol 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

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 42 weeks of gestation
• live singleton
• Bishop score \< or = 6
• reassuring fetal heart beat pattern

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Beigang Hospital

Douliu, 651, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 11563466 RESULT

• 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.

  PMID: 34155622 DERIVED

• 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.

  PMID: 18165400 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Shi-Yann Cheng, M.D.

  Chinal Medical University Beigang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2007
• First Posted: September 14, 2007
• Study Start: June 1, 2005
• Study Completion: March 1, 2007
• Last Updated: September 14, 2007

Record last verified: 2006-09

Locations

TW (1)