Tension vs No Tension for Induction of Labor

Overseen By Holly Olson, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hawaii Pacific Health

Disqualifiers: Multiparas, Multiple gestation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Until delivery

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods to initiate labor using a Foley catheter. The goal is to determine whether applying tension or not on the catheter, combined with the medication Misoprostol, affects labor preparation. The trial targets first-time mothers with one baby, planning labor induction at Kapiolani Medical Center. Women with previous surgeries on their uterus or cervix, or certain pregnancy complications, are not eligible. As an unphased trial, this study allows participants to contribute to important research that could enhance labor induction methods.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods are safe for cervical ripening?

Research has shown that using a Foley catheter to prepare the cervix for labor is generally safe. Studies have found that both methods—using tension and not using tension—are well-tolerated by patients. One study found that the time from catheter insertion to delivery is similar, regardless of tension use, indicating both methods are equally safe.

Another study found that adding tension to the Foley balloon does not significantly alter delivery time or improve outcomes, suggesting that using tension does not increase safety risks. Overall, both methods have been used without major safety issues, and participants in previous studies did not report significant negative effects from either method.

In conclusion, both the tension and no-tension methods with a Foley catheter are safe options for preparing the cervix for labor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to induction of labor. Unlike standard methods, which often involve medications like oxytocin to stimulate contractions, this trial investigates the use of a Foley balloon with two different techniques: "Tension" and "No Tension." The "Tension" method involves applying tension by taping the balloon to the thigh, potentially enhancing its effectiveness, while the "No Tension" method tapes the balloon loosely. By comparing these two techniques, researchers aim to discover if one approach leads to a more efficient or safer induction process, potentially offering new insights into optimizing labor induction.

What evidence suggests that this trial's treatments could be effective for cervical ripening?

This trial will compare the use of tension versus no tension on a Foley catheter for labor induction. Research has shown that pulling on a Foley catheter during labor induction does not speed up delivery. Studies have found no significant difference in delivery time whether tension is used or not. One study noted that the average time from catheter insertion to birth was about 16 hours for both methods. Another analysis confirmed that using tension did not significantly change delivery time or reduce the likelihood of needing a cesarean section. Overall, both methods appear to work similarly in terms of delivery speed. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for first-time pregnant women over 18 with a single baby in head-down position, who need help starting labor at Kapiolani Medical Center. They should have an unopened cervix and a Bishop score of 6 or less, which means the body isn't quite ready for childbirth on its own.

Inclusion Criteria

Intact fetal membranes

Bishop score less than or equal to 6

Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children

Exclusion Criteria

Multiple gestation

Any contraindication to vaginal delivery at time of admission

I have had surgery on my uterus or cervix before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening

Until delivery

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NO TENSION
• Tension

Trial Overview The study is testing two ways to use a Foley bulb catheter to ripen the cervix and get it ready for labor: one group will have tension applied to the catheter, while the other won't. The goal is to see which method works best for starting labor.

How Is the Trial Designed?

Group I: Tension Active Control 1 Intervention

foley balloon will be placed on tension and taped to thigh at 10 cm. Misoprostil will be placed in posterior vaginal vault.

Group II: No tension Active Control 1 Intervention

The foley balloon will be loosely taped without tension to the patient's thigh. Misoprostil will be placed in the posterior vaginal vault.

Who Is Running the Clinical Trial?

Hawaii Pacific Health

Lead Sponsor

Trials

10

Recruited

600+

Published Research Related to This Trial

In a study involving 188 women with an unfavorable cervix, the addition of extraamniotic saline infusion to a transcervical Foley catheter did not significantly improve the induction-to-delivery interval compared to using the Foley catheter alone.

Both methods resulted in similar rates of cesarean delivery and maternal and neonatal outcomes, indicating that the extra saline infusion does not enhance the efficacy of labor induction in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial. Lin, MG., Reid, KJ., Treaster, MR., et al.[2015]

In a study of 70 women with a previous caesarean section, both the transcervical Foley catheter and PGE2 gel were found to be safe and effective for inducing labor, with no cases of uterine rupture or scar dehiscence reported.

The Foley catheter resulted in a shorter induction to delivery interval (18.15 hours) compared to the PGE2 gel (21.06 hours), and it offers advantages such as lower cost, reversibility, and a reduced risk of serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The transcervical foley catheter versus the vaginal prostaglandin e2 gel in the induction of labour in a previous one caesarean section - a clinical study. Ziyauddin, F., Hakim, S., Beriwal, S.[2021]

Intravaginal misoprostol significantly shortens the induction to delivery interval (14.03 hours) compared to the transcervical Foley catheter (18.40 hours), making it a more efficient option for labor induction.

While misoprostol increases the rate of vaginal deliveries (76.7% vs. 56.8% for Foley catheter), it is associated with a higher incidence of uterine hyperstimulation, indicating a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foley Catheter versus Vaginal Misoprostol for Labour Induction. Noor, N., Ansari, M., Ali, SM., et al.[2022]

Using a transcervical Foley catheter alone for labor induction in women with an unfavorable cervix resulted in a higher success rate for normal vaginal delivery compared to using oxytocin alone.

While the Foley catheter alone increased the likelihood of vaginal delivery, it also led to a longer induction delivery interval, but required significantly less oxytocin, indicating a potential benefit in reducing medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix. El Khouly, NI.[2017]

In a study of 200 nulliparous women with an unfavorable cervix, using an 80 mL Foley catheter with vaginal misoprostol significantly shortened the induction-delivery interval compared to a 60 mL Foley catheter, with a median time of 604 minutes versus 846 minutes (P<.001).

The 80 mL Foley catheter also reduced the number of misoprostol doses needed for labor induction (1.4 doses vs 2.4 doses, P<.001), while maternal and neonatal morbidity rates remained similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foley catheter (80 vs 60 mL) and misoprostol for labor induction in nulliparous women: a randomized controlled trial. Sharma, C., Jaryal, S., Soni, A.[2023]

In a study of 45 women undergoing labor induction with an intracervical Foley catheter, there was a significant increase in pathogenic organisms in cervical swabs after catheter insertion, indicating a potential risk of infection.

Despite routine aseptic measures, 16.3% of women showed growth of harmful bacteria or fungi post-insertion, and one woman (2.2%) developed a fever, suggesting that careful aseptic techniques are crucial to minimize infection risks during this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased risk of cervical canal infections with intracervical Foley catheter. Siddiqui, S., Zuberi, NF., Zafar, A., et al.[2015]

In a study of 162 nulliparous women, the use of an intracervical Foley catheter with oxytocin for labor induction showed similar efficacy and safety compared to vaginal misoprostol, with no significant difference in cesarean delivery rates (35% for misoprostol vs. 29% for Foley/oxytocin).

The Foley catheter combined with oxytocin resulted in a significantly shorter induction-to-delivery time (18 hours) compared to misoprostol (24 hours), indicating a more efficient labor induction method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women. Culver, J., Strauss, RA., Brody, S., et al.[2013]

In a study of 226 women, the use of a transcervical Foley catheter for labor induction showed comparable caesarean section rates to vaginal prostaglandin E2 inserts, with rates of 20% and 22% respectively, indicating similar effectiveness.

The meta-analysis revealed that while both methods had similar outcomes, the Foley catheter was associated with significantly fewer cases of hyperstimulation during the labor induction process, suggesting a potential safety advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature. Jozwiak, M., Oude Rengerink, K., Ten Eikelder, ML., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27640940/

Tension compared to no tension on a Foley transcervical ... Conclusion: Application of tension did not result in faster delivery times but did result in faster times to catheter expulsion. Keywords: Foley bulb; cervical ...

2. ajog.org ajog.org/article/S0002-9378(16)30789-X/abstract

Tension compared to no tension on a Foley transcervical ... The median time from catheter insertion to delivery was not significantly different between the tension group and the no tension group (16.2 vs 16.9 hours; P=.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933322000520

Traction vs no traction in Foley catheter use for induction of ... This meta-analysis of 4 RCTs10,11,14,15 showed that traction placed on the cervical Foley catheter did not significantly reduce time to delivery or cesarean ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03588585

Tension Versus no Tension With Foley Bulb Induction Study Overview. Brief Summary. To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

5. ajogmfm.org ajogmfm.org/article/S2589-9333(22)00052-0/abstract

Traction vs no traction in Foley catheter use for induction ... The primary outcome was the mean time from induction to delivery in hours. Meta-analysis was performed using the random-effects model of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937815025958

Foley catheter placement for induction of labor with or ... Foley catheter insertions with and without a stylette are equivalent in insertion times, patient pain levels, and failure of catheter placement.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7898639/

Induction of labor with Foley catheter and risk of subsequent ... The overall rate of PTB in a subsequent pregnancy was 9/251 (3.6%) in the Foley catheter group vs 10/258 (3.9%) in the prostaglandin group (relative risk (RR), ...