DEVICE
Foley balloon
Foley balloon for induction of labor
Induction of Labor After Cesarean Using Foley Alone vs. Concurrent Foley and Oxytocin
Status
Active, not recruiting
Phase
Not applicable
Enrollment
100
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Oxytocin
Pitocin for induction of labor
Timeline
From registration to results.
First posted
Jun 5, 2025
Study start
Jul 10, 2025
Primary completion
Jul 2026
Study completion
May 1, 2027
Results posted
Not reported
Registry updated
Jun 18, 2026
Outcomes
What the study measures.
Primary outcomes
Time to delivery
Time frame · At delivery
The primary endpoint will be time from start of induction until delivery (hours)
Secondary outcomes
Estimated postpartum blood loss
Time frame · At delivery
Estimated postpartum blood loss in mL
Postpartum hemorrhage
Time frame · Within 6 weeks of delivery
Estimated blood loss≥ 1L
Number of Participants with Chorioamnionitis
Time frame · At delivery
Documented chorioamnionitis
Mode of delivery
Time frame · At delivery
Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)
Number of Participants with Uterine Rupture
Time frame · At delivery
Uterine rupture noted at the time of cesarean delivery
Maternal morbidity
Time frame · Within 6 weeks of delivery
Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolism and hospital readmission with 6 weeks
Neonatal morbidity
Time frame · Within 6 weeks of delivery
Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis
Maternal length of stay
Time frame · From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Measured by hours from admission to postpartum discharge
Neonatal length of stay
Time frame · From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Length of stay from birth to discharge, measured in hours
NICU stay greater than 48 hours
Time frame · From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Admission to the NICU for more than 48 hours
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * Eligible for induction of labor * 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: * \>1 prior Cesarean delivery * Known chorioamnionitis * Major fetal anomaly
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Publications
Results and literature.
PMID 18929686 ↗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.PMID 10480822 ↗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.PMID 20332509 ↗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.PMID 31645154 ↗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.PMID 28937571 ↗Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.PMID 35869943 ↗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.PMID 35135684 ↗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.PMID 34708257 ↗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.PMID 26365010 ↗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.PMID 28599068 ↗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.PMID 27521597 ↗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.PMID 35751576 ↗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.
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