Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

NCT00695331 | Unknown Phase 4 DMC

• 2 other identifiers: CMUBH R96007DMR96-IRB-176
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.

Conditions

Labor

Keywords

Labor Augmentation; Misoprostol; Oxytocin

Outcome Measures

Primary Outcomes (1)

• the percentage of women delivering infants vaginally within 12 hours of augmentation

  post vaginal delivery

Secondary Outcomes (1)

• uterine hyperstimulation rate

  post vaginal delivery

Study Arms (2)

1

EXPERIMENTAL

Titrated Oral Misoprostol Solution

Drug: Misoprostol

2

ACTIVE COMPARATOR

Intravenous Oxytocin

Drug: Oxytocin

Interventions

Misoprostol DRUG

Titrated Misoprostol Solution

Also known as: Cytotec

1

Oxytocin DRUG

Titrated Intravenous Oxytocin

Also known as: Piton-S

2

Eligibility Criteria

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

You may qualify if:

• Pregnancy between 36 and 42 weeks of gestation
• Live singleton
• Cephalic presentation
• A reassuring fetal heart rate pattern
• Bishop score greater than 6
• Inadequate uterine contraction (less than or equal to 2 per 10 minutes)

You may not qualify if:

• Nonreassuring fetal heart rate pattern
• Parity more than five
• Uterine scar
• Suspected placental abruption with abnormal fetal heart rate
• Vaginal bleeding other than "bloody show"
• Significant maternal cardiac, renal, or hepatic disease
• hypersensitivity to oxytocin, misoprostol or prostaglandin analogues

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital

Taichung, 404, Taiwan

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• Ho M, Cheng SY, Li TC. Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.

  PMID: 20733443 DERIVED

Related Links

• China Medical University Hospital

MeSH Terms

Interventions

Misoprostol; Oxytocin

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Shi-Yann Cheng, MD

  China Medical University Beigang Hospital

  STUDY CHAIR

Central Study Contacts

Ming Ho, MD

CONTACT

886-4-22062121; mi.ho@msa.hinet.net

Shi-Yann Cheng, MD

CONTACT

886-5-7837901; shiyann@ms18.url.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2008
• First Posted: June 11, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: July 10, 2008

Record last verified: 2008-07

Locations

TW (1)