NCT00504465

Brief Summary

To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2007

Completed
Last Updated

July 20, 2007

Status Verified

July 1, 2007

First QC Date

July 19, 2007

Last Update Submit

July 19, 2007

Conditions

Labor InductionCervical Ripening

Keywords

LaborLabor inductionCervical ripeningDinoprostoneFetal safetyOxytocinCesarean delivery

Outcome Measures

Primary Outcomes (1)

  • Rate of vaginal delivery <24 hours

Secondary Outcomes (3)

  • Randomization to delivery interval

  • Rate of cesarean delivery for non reassuring fetal status

  • Rate of uterine hyperstimulation

Interventions

dinoprostoneDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \> or = to 36 weeks of gestation
  • Singleton fetus
  • Cephalic presentation
  • Intact membranes and an unripe cervix (Bishop score \<6)

You may not qualify if:

  • Multifetal gestation
  • Rupture of membranes
  • Ripe cervix (Bishop score \>6)
  • Active labor
  • Contraindication to vaginal delivery
  • Previous uterine surgery
  • Non-cephalic presentation
  • Fetal macrosomia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

New York Hospital Medical Center of Queens

Flushing, New York, 11355, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Daniel W Skupski, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Michael Cabbad, MD

    The Brooklyn Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2007

First Posted

July 20, 2007

Study Start

May 1, 2002

Study Completion

April 1, 2007

Last Updated

July 20, 2007

Record last verified: 2007-07

Locations

US(3)