Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
NCT ID: NCT00290199
Last Updated: 2017-05-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
169 participants
INTERVENTIONAL
2005-12-31
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women
NCT03472937
Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
NCT02546193
Outpatient Foley For Starting Induction of Labor at TErm
NCT02756689
Foley vs Propess for Induction of Labor in Women With Term PROM : Mode of Delivery, Maternal and Fetal Outcomes
NCT04565340
Foley Catheter Induction
NCT05257187
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transcervical Foley Catheter
Transcervical Foley catheter
Foley catheter placed through cervix for cervical ripening
No Foley
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcervical Foley catheter
Foley catheter placed through cervix for cervical ripening
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Cervix ≤ 2 centimeters (cm)
3. Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
4. Singleton gestation
5. Cephalic
6. Vertex well applied to cervix
Exclusion Criteria
2. Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
3. Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
4. Lethal fetal anomalies
5. Intrauterine fetal demise (IUFD)
6. Previa
7. Suspected abruption/significant hemorrhage
8. Non-reassuring fetal heart rate (FHR) pattern
9. Non vertex fetal presentation
12 Years
55 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alan Tita
Assoc Prof
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alan T Tita, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Christiana Care Health System
Newark, Delaware, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F051021005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.