Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women
NCT ID: NCT03472937
Last Updated: 2020-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
126 participants
INTERVENTIONAL
2018-05-04
2019-12-13
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
NCT02756689
Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
NCT00290199
Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
NCT02975167
Foley Catheter Induction
NCT05257187
Outpatient Foley Cervix Priming
NCT02842879
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home.
The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.
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.
Inpatient cervical ripening group
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
Transcervical Foley catheter placement for cervical ripening
Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
Outpatient cervical ripening group
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (intervention arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next day to be admitted to labor and delivery for induction of labor with oxytocin.
Transcervical Foley catheter placement for cervical ripening
Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transcervical Foley catheter placement for cervical ripening
Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Nulliparous
* Singleton gestation
* Gestational age between 39+0 and 42+0 weeks
* Vertex presentation
* Modified Bishop score \<5 and cervical dilation ≤ 2 cm
* No prior cesarean or prior uterine surgery
* Resides within 30 minutes of UAB Hospital
* Access to a telephone
* Reliable transportation
Exclusion Criteria
* Latex allergy
* Contraindication to induction of labor
* Evidence of labor
* Fetal demise
* Fetal anomaly
* Inability to give consent (e.g., inability to read or write)
18 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.
Elizabeth B. Ausbeck
Fellow, Maternal-Fetal Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth B Ausbeck, 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
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.
ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.
O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. doi: 10.1016/0002-9378(95)90440-9.
Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. doi: 10.1016/s0029-7844(99)00244-6.
Rayburn W, Gosen R, Ramadei C, Woods R, Scott J Jr. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1417-23. doi: 10.1016/0002-9378(88)90376-6.
Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol. 1994 Nov;84(5):807-10.
Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can. 2003 Jan;25(1):23-31. doi: 10.1016/s1701-2163(16)31079-9.
Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, Casey BM, Szychowski JM, Harper LM, Tita AT. Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):597-606. doi: 10.1097/AOG.0000000000004041.
Related Links
Access external resources that provide additional context or updates about the study.
WHO Recommendations for Induction of Labour
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
F9999999
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.