NCT00325026

Brief Summary

The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 2, 2012

Status Verified

March 1, 2012

First QC Date

May 10, 2006

Last Update Submit

March 1, 2012

Conditions

Premature BirthCervical Ripening

Keywords

Preterm gestationCervical ripeningLabor inductionMisoprostolFoley bulb

Outcome Measures

Primary Outcomes (1)

  • Time to vaginal delivery

Secondary Outcomes (4)

  • Rate of chorioamnionitis

  • Incidence of abnormal fetal heart rate tracings

  • Rate of postpartum hemorrhage

  • Incidence of NICU admissions

Interventions

MisoprostolDRUG
Foley bulbDEVICE

Eligibility Criteria

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

You may qualify if:

  • singleton gestation, gestational age 23-35 weeks, indication for induction

You may not qualify if:

  • multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Keri a Baacke, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

April 1, 2005

Study Completion

April 1, 2007

Last Updated

March 2, 2012

Record last verified: 2012-03

Locations

US(1)