Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin
NCT ID: NCT07006896
Last Updated: 2025-07-18
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
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-10
2027-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Concurrent Foley balloon and Oxytocin
Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Foley balloon
Foley balloon for induction of labor
Oxytocin
Pitocin for induction of labor
Foley balloon alone
Cervical ripening will begin with a Foley balloon alone. Oxytocin will not be started until the balloon is removed or expelled, though can be considered if the balloon remains in place for \>8 hours
Foley balloon
Foley balloon for induction of labor
Interventions
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Foley balloon
Foley balloon for induction of labor
Oxytocin
Pitocin for induction of labor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Live singleton gestation ≥37 weeks
* History of 1 cesarean delivery
* ≥18 years of age
* Cephalic presentation
* Intact membranes
* English or Spanish speaking (Able to read/understand consent and instructions)
* Cervical dilation \<3cm and Bishop score \<8
Exclusion Criteria
* Known chorioamnionitis
* Major fetal anomaly
18 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Lisa Levine
Associate Professor
Principal Investigators
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Lisa Levine, MD MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670.
Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
Levine LD, Downes KL, Hamm RF, Srinivas SK. Evaluating the impact of a standardized induction protocol to reduce adverse perinatal outcomes: a prospective cohort study. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3200-3207. doi: 10.1080/14767058.2019.1680629. Epub 2019 Oct 24.
Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
Jamaluddin A, Azhary JMK, Hong JGS, Hamdan M, Tan PC. Early versus delayed amniotomy with immediate oxytocin after Foley catheter cervical ripening in multiparous women with labor induction: A randomized controlled trial. Int J Gynaecol Obstet. 2023 Feb;160(2):661-669. doi: 10.1002/ijgo.14361. Epub 2022 Aug 8.
Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6.
Secchi D, Alberic J, Gobillot S, Ghenassia A, Roustit M, Chauleur C, Hoffmann P, Raia-Barjat T. Balloon catheter vs oxytocin alone for induction of labor in women with one previous cesarean section and an unfavorable cervix: a multicenter, retrospective study. Arch Gynecol Obstet. 2022 Aug;306(2):379-387. doi: 10.1007/s00404-021-06298-y. Epub 2021 Oct 28.
Hoffman MK, Hunter Grant G. Induction of labor in women with a prior cesarean delivery. Semin Perinatol. 2015 Oct;39(6):471-4. doi: 10.1053/j.semperi.2015.07.011. Epub 2015 Sep 11.
West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD009792. doi: 10.1002/14651858.CD009792.pub3.
Kehl S, Weiss C, Rath W. Balloon catheters for induction of labor at term after previous cesarean section: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:44-50. doi: 10.1016/j.ejogrb.2016.07.505. Epub 2016 Aug 3.
Levin G, Tsur A, Burke YZ, Meyer R. Methods of induction of labor after cesarean with no prior vaginal delivery-Perinatal outcomes. Int J Gynaecol Obstet. 2023 Feb;160(2):612-619. doi: 10.1002/ijgo.14318. Epub 2022 Jul 14.
Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med. 2004 Dec 16;351(25):2581-9. doi: 10.1056/NEJMoa040405. Epub 2004 Dec 14.
Deshmukh U, Denoble AE, Son M. Trial of labor after cesarean, vaginal birth after cesarean, and the risk of uterine rupture: an expert review. Am J Obstet Gynecol. 2024 Mar;230(3S):S783-S803. doi: 10.1016/j.ajog.2022.10.030. Epub 2023 Jul 13.
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.
Bruno AM, Allshouse AA, Metz TD. Trends in Attempted and Successful Trial of Labor After Cesarean Delivery in the United States From 2010 to 2020. Obstet Gynecol. 2023 Jan 1;141(1):173-175. doi: 10.1097/AOG.0000000000004998. Epub 2022 Nov 30.
ACOG Practice Bulletin No. 205: Vaginal Birth After Cesarean Delivery. Obstet Gynecol. 2019 Feb;133(2):e110-e127. doi: 10.1097/AOG.0000000000003078.
Stephenson J. Rate of First-time Cesarean Deliveries on the Rise in the US. JAMA Health Forum. 2022 Jul 1;3(7):e222824. doi: 10.1001/jamahealthforum.2022.2824. No abstract available.
Other Identifiers
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858270
Identifier Type: -
Identifier Source: org_study_id
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