Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin

Summary

A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction. With this trial, the investigators aim to test our central hypothesis that concurrent Foley and Oxytocin will decrease time to delivery without increasing risks, compared to Foley alone.

Timeline

Start

2025-07-10

Primary completion

2026-07

Completion

2027-05-01

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background ACOG Practice Bulletin No. 205: Vaginal Birth After Cesarean Delivery. Obstet Gynecol. 2019 Feb;133(2):e110-e127. doi: 10.1097/AOG.0000000000003078.
• Background 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.

Drugs

Indications

No indication recorded.