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Labor InductionLIFTNCT07006896

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

A study testing Foley balloon and Oxytocin in people with Labor Induction and Cesarean Delivery, run by University of Pennsylvania at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Labor Induction, Cesarean Delivery
What is being tested?
Foley balloon and Oxytocin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
10 Jul 2025to 1 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • >1 prior Cesarean delivery
  • Known chorioamnionitis
  • Major fetal anomaly

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: Labor Induction After Cesarean: A Randomized Trial Of Cervical Balloon With or Without Oxytocin

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.

Being tested
Foley balloon, Oxytocin
Keywords
Labor, Induction, Cesarean, TOLAC, Foley, Oxytocin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foley balloonDevice

    Also called Foley catheter, Cervical ripening balloon

    Foley balloon for induction of labor

  • OxytocinDrug

    Also called Pitocin

    Pitocin for induction of labor

Study groups in NCT07006896
Study groupRoleWhat they receive
Concurrent Foley balloon and OxytocinExperimentalCervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement
Receives: Device: Foley balloon; Drug: Oxytocin
Foley balloon aloneActive comparatorCervical 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
Receives: Device: Foley balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to delivery

    The primary endpoint will be time from start of induction until delivery (hours)

    Measured: At delivery

Secondary outcomes (11)

  1. Estimated postpartum blood loss

    Estimated postpartum blood loss in mL

    Measured: At delivery

  2. Postpartum hemorrhage

    Estimated blood loss≥ 1L

    Measured: Within 6 weeks of delivery

  3. Number of Participants with Chorioamnionitis

    Documented chorioamnionitis

    Measured: At delivery

  4. Mode of delivery

    Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD)

    Measured: At delivery

  5. Number of Participants with Uterine Rupture

    Uterine rupture noted at the time of cesarean delivery

    Measured: At delivery

  6. Maternal morbidity

    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

    Measured: Within 6 weeks of delivery

  7. Neonatal morbidity

    Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis

    Measured: Within 6 weeks of delivery

  8. Maternal length of stay

    Measured by hours from admission to postpartum discharge

    Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

  9. Neonatal length of stay

    Length of stay from birth to discharge, measured in hours

    Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

  10. NICU stay greater than 48 hours

    Admission to the NICU for more than 48 hours

    Measured: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery

  11. Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R)

    Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction

    Measured: From time of delivery to discharge from hospital, up to 6 weeks from delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start10 Jul 2025
  3. Primary completion25 Jul 2026
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07006896
Sponsor's protocol ID
858270
Acronym
LIFT
Status last verified
Sep 2026
First submitted
27 May 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18929686

  • 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.

    PubMed 10480822

  • 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.

    PubMed 20332509

  • 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.

    PubMed 31645154

  • Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

    PubMed 28937571

  • 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.

    PubMed 35869943

  • 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.

    PubMed 35135684

  • 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.

    PubMed 34708257

  • 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.

    PubMed 26365010

  • 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.

    PubMed 28599068

  • 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.

    PubMed 27521597

  • 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.

    PubMed 35751576

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 19623003

Questions about this trial

What is this clinical trial studying?

A study testing Foley balloon and Oxytocin in people with Labor Induction and Cesarean Delivery, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to delivery (time frame: At delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07006896, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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