NCT00393731

Brief Summary

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

Enrollment Period

3.6 years

First QC Date

October 26, 2006

Last Update Submit

January 11, 2008

Conditions

Labor, Induced

Keywords

laborinductionmisoprostoloxytocin

Outcome Measures

Primary Outcomes (1)

  • Vaginal Delivery rates

Secondary Outcomes (1)

  • Time interval to delivery

Interventions

MisoprostolDRUG
oxytocinDRUG

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women that are hospitalized for induction of labor that have a Bishop's score \<5
  • singleton gestation
  • cephalic presentation
  • weeks gestational age

You may not qualify if:

  • Prior uterine surgery
  • malpresentation
  • placenta previa or abruption
  • clinically suspected or diagnosed intra amniotic infection
  • genital HSV infection
  • multiple gestation
  • premature rupture of the membranes
  • active labor
  • maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lyndon B. Johnson Hospital

Houston, Texas, 77026, United States

Location

MeSH Terms

Interventions

MisoprostolOxytocin

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Michael Lucas, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2006

First Posted

October 30, 2006

Study Start

January 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 16, 2008

Record last verified: 2008-01

Locations

US(1)