Foley Catheter + Oxytocin for Labor Induction After C-Section

(LIFT Trial)

Overseen By Hannah Foster, MD, MAUB

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Multiple cesareans, Chorioamnionitis, Fetal anomaly

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using a Foley catheter with Oxytocin, a hormone that induces labor, can accelerate labor without increasing risks for women with one previous Cesarean delivery. The research compares two methods: using only the Foley catheter or combining it with Oxytocin from the beginning. Women who are at least 37 weeks pregnant with one baby, have had one C-section, and meet other specific criteria may qualify for this study. These criteria include having an intact amniotic sac and a cervical dilation of less than 3 cm. The goal is to determine if combining these treatments can result in a quicker and safe delivery. As an unphased trial, this study allows participants to contribute to important research that could enhance labor outcomes for women with prior C-sections.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a Foley balloon and oxytocin together to induce labor is generally safe for women with a previous C-section. One study found that this combination softens and opens the cervix, often resulting in a successful vaginal birth. Another study noted that using a Foley balloon does not significantly increase the risk of complications for mothers or babies compared to planning a C-section. Additionally, oxytocin speeds up delivery times without major safety concerns. Overall, these treatments are well-tolerated, with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using a Foley catheter combined with oxytocin for labor induction after a C-section because it offers a potentially more efficient way to start labor. Unlike standard methods that often use one technique at a time, this approach simultaneously uses a Foley balloon to mechanically open the cervix while oxytocin stimulates contractions. This dual-action method may speed up the process of labor induction, which could be particularly beneficial for women who have had a previous C-section. Additionally, using these treatments together might lead to a more controlled and predictable induction process, which is something the medical community is eager to explore.

What evidence suggests that this trial's treatments could be effective for labor induction after a C-section?

This trial will compare the use of a Foley balloon alone with the concurrent use of a Foley balloon and Oxytocin for labor induction after a C-section. Research has shown that using both a Foley balloon and Oxytocin to start labor can be effective. One study found that individuals using Oxytocin were more likely to have a vaginal birth within 24 hours compared to those who did not use it. Another study demonstrated that using both a balloon and Oxytocin together accelerated delivery. Additionally, the chance of having a vaginal birth was higher for those using Oxytocin than for those using just a balloon. These findings suggest that using both a Foley balloon and Oxytocin could lead to quicker deliveries without increasing risks. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa Levine, MD MSCE

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals who are at term (≥37 weeks) and need labor induced, with a history of one prior Cesarean delivery. The study is looking to include those where the medical provider plans to use a Foley catheter for cervical ripening.

Inclusion Criteria

History of 1 cesarean delivery

I am pregnant with one baby and at least 37 weeks along.

I am 18 years old or older.

Exclusion Criteria

>1 prior Cesarean delivery

Major fetal anomaly

Known chorioamnionitis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Induction

Participants undergo induction of labor using either Foley balloon alone or concurrent Foley and Oxytocin

Hours to delivery

In-hospital stay

Delivery

Time from start of induction until delivery

Hours

In-hospital stay

Postpartum Follow-up

Participants are monitored for maternal and neonatal outcomes, including satisfaction, morbidity, and length of stay

Up to 6 weeks from delivery

In-hospital stay and follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Foley balloon
• Oxytocin

Trial Overview The study compares two methods of inducing labor: using only a Foley balloon versus using both a Foley balloon and Oxytocin simultaneously from the start. The goal is to see if adding Oxytocin reduces time to delivery without increasing risks.

How Is the Trial Designed?

Group I: Concurrent Foley balloon and Oxytocin Experimental Treatment 2 Interventions

Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement

Group II: Foley balloon alone Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. smw.ch smw.ch/index.php/smw/article/download/2400/3688?inline=1

Safety and effectiveness of labour induction after ... RESULTS. We detected a vaginal delivery success rate of 45.8% in the catheter and of 63.9% in the oxytocin group. We identified previous vaginal birth as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6618009/

Balloon catheter for induction of labor in women with one ... The results of this prospective cohort study show that in women with one previous cesarean section and an unfavorable cervix, induction of labor with a balloon ...

3. ajog.org ajog.org/article/S0002-9378(23)00081-9/fulltext

Methods for the induction of labor: efficacy and safety The authors found that patients receiving oxytocin were less likely not to deliver vaginally within 24 hours than those receiving expectant ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000293782100185X

Six versus twelve hours of single-balloon catheter ... Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time ...

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.13712

Balloon catheter vs oxytocin alone for induction of labor in ... Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8804105/

Outcome of Induction of Labor with Foley's Catheter in ... Induction of labor with Foley's catheter resulted in a 40% successful vaginal birth rate and was found to be safe with only one scar dehiscence.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933324003057

Tugging the Foley catheter balloon every three hours in ... IOLAC with a balloon catheter does not significantly increase adverse maternal and neonatal outcomes when compared with planned cesarean delivery.13 IOLAC with ...

8. article.imrpress.com article.imrpress.com/journal/CEOG/49/1/10.31083/j.ceog4901029/2709-0094-49-1-029.pdf

Cervical balloon combined with oxytocin improves clinical ... Results: The overall effective rate of cervical maturation after labor induction was 88.8%, and the proportion of vaginal delivery in the CBO ...