Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin
| Registry | NCT07006896, acronym LIFT |
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| Status | Active not recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 100 (Estimated) |
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| Sponsor | University of Pennsylvania (Other) |
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| Conditions | Labor Induction, Cesarean Delivery |
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| Interventions | Foley balloon, Oxytocin (Device, drug) |
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| Dates | start 2025-07-10, primary completion 2026-07-25, completion 2027-05-01 (estimated), first posted 2025-06-05, last updated 2026-09-03 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Labor Induction All trials for Cesarean Delivery All trials of Foley balloon All trials of 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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Concurrent Foley balloon and Oxytocin | Experimental | Device: Foley balloon; Drug: Oxytocin | Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement |
| Foley balloon alone | Active comparator | Device: Foley balloon | 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 (Device), also known as Foley catheter, Cervical ripening balloon: Foley balloon for induction of labor
- Oxytocin (Drug), also known as Pitocin: Pitocin for induction of labor
+Outcome measures
Primary outcomes
- Time to delivery [At delivery]: The primary endpoint will be time from start of induction until delivery (hours)
Secondary outcomes
- Estimated postpartum blood loss [At delivery]: Estimated postpartum blood loss in mL
- Postpartum hemorrhage [Within 6 weeks of delivery]: Estimated blood loss≥ 1L
- Number of Participants with Chorioamnionitis [At delivery]: Documented chorioamnionitis
- Mode of delivery [At delivery]: Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)
- Number of Participants with Uterine Rupture [At delivery]: Uterine rupture noted at the time of cesarean delivery
- Maternal morbidity [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 [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 [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 [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 [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
- Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R) [From time of delivery to discharge from hospital, up to 6 weeks from delivery]: Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction
+Eligibility
Sex: Female, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania | United States | |
+Publications
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- 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. PMID 15598960
- 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. PMID 38462257
- 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. PMID 19623003
- 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. PMID 36701618
- ACOG Practice Bulletin No. 205: Vaginal Birth After Cesarean Delivery. Obstet Gynecol. 2019 Feb;133(2):e110-e127. doi: 10.1097/AOG.0000000000003078. PMID 30681543
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+Investigators