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

Trial Summary

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 data supports the idea that Tension vs No Tension for Induction of Labor is an effective treatment?

The available research shows that using a Foley catheter for labor induction can be effective. One study found that using a Foley catheter alone led to more successful normal vaginal deliveries compared to using oxytocin alone. Another study compared the Foley catheter to prostaglandin E2 inserts and found it to be a safe and effective option for inducing labor. These findings suggest that the Foley catheter, whether used with or without tension, is a viable treatment for inducing labor. ^{1 2 3 4 5}

What safety data exists for using a Foley catheter for labor induction?

The safety of using a transcervical Foley catheter for labor induction has been evaluated in several studies. These studies compare the Foley catheter to other methods like prostaglandin E2 inserts, vaginal misoprostol, and oxytocin. The research generally focuses on the effectiveness and safety of the Foley catheter, both with and without additional interventions like extraamniotic saline infusion or oxytocin. The studies indicate that the Foley catheter is a safe option for labor induction, with some studies showing it to be more effective in certain scenarios, such as achieving successful normal vaginal delivery or reducing induction delivery time. ^{1 2 4 6 7}

Is the treatment in the trial 'Tension vs No Tension for Induction of Labor' a promising treatment?

The treatment involving the Foley catheter for inducing labor seems promising. Studies show it can be effective in helping women have a normal vaginal delivery, especially when combined with other methods like oxytocin. It also appears to work well in shortening the time it takes for labor to progress. ^{1 2 3 4 8}

What is the purpose of this trial?

To compare the application of tension versus no tension in Foley transcervical catheters for pre-induction cervical ripening.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial. [2015]

2. England pubmed.ncbi.nlm.nih.gov

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

3. Pakistan pubmed.ncbi.nlm.nih.gov

Increased risk of cervical canal infections with intracervical Foley catheter. [2015]

4. Ireland 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women. [2013]

6. Egypt pubmed.ncbi.nlm.nih.gov

Foley Catheter versus Vaginal Misoprostol for Labour Induction. [2022]

7. India 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Foley catheter (80 vs 60 mL) and misoprostol for labor induction in nulliparous women: a randomized controlled trial. [2023]