Oxytocin/Foley vs. Oxytocin for PPROM

Overseen By Kristin Ayers, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Eastern Virginia Medical School

Disqualifiers: Spontaneous labor, HIV, prisoners, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 hours

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to induce labor for individuals experiencing preterm prelabor rupture of membranes (PPROM). Researchers compare two methods: using oxytocin (a hormone that stimulates contractions) alone and oxytocin combined with a Foley catheter (a device to help open the cervix). The goal is to determine which method leads to quicker delivery. Suitable participants have had their water break early, are between 34 to 36 weeks pregnant, and have a cervix that is not too open yet. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

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 doctor.

What is the safety track record for these treatments?

Research has shown that using oxytocin with a Foley catheter is generally safe for patients whose water has broken before labor begins. Studies comparing this combination to using only oxytocin to induce labor suggest that adding a Foley catheter does not significantly speed up delivery compared to just using oxytocin.

Both oxytocin and the Foley catheter are commonly used in medical settings to help start labor. Oxytocin initiates or strengthens labor contractions, while the Foley catheter, a small balloon-like device, is inserted into the cervix to help it open.

Safety data from previous studies indicate no significant increase in side effects when using both oxytocin and the Foley catheter together. This suggests that most patients tolerate the treatment well. However, like any medical procedure, risks exist, so discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for preterm premature rupture of membranes (PPROM) because they offer a potentially more effective way to induce labor. Unlike the standard approach, which typically uses oxytocin alone, the experimental method combines oxytocin with a transcervical Foley catheter. This combination might enhance cervical ripening, potentially leading to a smoother and more efficient labor induction process. By exploring this combination, researchers aim to improve outcomes for both mothers and babies in cases of PPROM.

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

This trial will compare the use of Oxytocin alone with Oxytocin plus a Foley catheter for inducing labor in cases of preterm premature rupture of membranes (PPROM). Research has shown that using a Foley catheter with oxytocin might be more effective for initiating labor in full-term pregnancies, increasing the likelihood of giving birth within 24 hours compared to using oxytocin alone. However, studies on early pregnancies with premature rupture of membranes have produced mixed results. Some research suggests that the Foley catheter does not significantly accelerate delivery in these cases. While promising for full-term pregnancies, its effectiveness for early pregnancies remains unclear. This trial aims to gather more information specifically about early pregnancies. ^{1 2 3 4 6}

Who Is on the Research Team?

Marwan Ma'ayeh, MD

Principal Investigator

Eastern Virginia Medical School

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who have experienced an early rupture of their amniotic sac, known as PPROM. Specific eligibility details are not provided, but typically participants would need to be in good health with no conditions that could interfere with the study.

Inclusion Criteria

I am between 18 and 50 years old.

PPROM

Cervical dilation ≤ 2cm

Exclusion Criteria

Known allergy to latex

Cervical dilation >2cm

Chorioamnionitis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Induction of labor with intravenous oxytocin and a transcervical Foley catheter or oxytocin alone

12 hours

1 visit (in-person)

Follow-up

Participants are monitored for maternal morbidity and adverse maternal outcomes

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxytocin
• Oxytocin plus Foley Catheter

Trial Overview The trial is testing two methods of inducing labor in patients with PPROM: one group receives just oxytocin (a hormone used to induce labor), while the other group gets a Foley catheter along with oxytocin to see which method leads to delivery within 24 hours more effectively.

How Is the Trial Designed?

Group I: Oxytocin plus Foley Experimental Treatment 1 Intervention

• Induction of labor with intravenous oxytocin and a transcervical Foley catheter

Group II: Oxytocin Only Active Control 1 Intervention

• Induction of labor with intravenous oxytocin

Who Is Running the Clinical Trial?

Eastern Virginia Medical School

Lead Sponsor

Trials

77

Recruited

16,500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37793430/

Combination Foley Catheter-Oxytocin versus ... Conclusion: In patients with PROM, the use of a transcervical Foley catheter in addition to oxytocin is not associated with a shorter time to delivery compared ...

2. thieme-connect.com thieme-connect.com/products/ejournals/pdf/10.1055/a-2185-4102.pdf

Combination Foley Catheter–Oxytocin versus Oxytocin Alone ... Thus, the study objective was to evaluate effectiveness and safety of the balloon catheter for induction in preterm membrane rupture and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07119398

Study Details | NCT07119398 | Oxytocin/Foley vs. ... The preponderance of evidence from term pregnancies suggests that Foley catheter coupled with oxytocin is better than oxytocin alone, with a higher rate of ...

4. ajog.org ajog.org/article/S0002-9378(16)31971-8/fulltext

103: Foley plus oxytocin versus oxytocin alone for labor ... Transcervical Foley plus oxytocin infusion does not offer an advantage over oxytocin infusion alone for labor induction in women ≥34weeks with PROM.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933323000101

Evaluation of mechanical and nonmechanical methods ... This study aimed to evaluate and compare the effects of oral misoprostol and Foley catheterization in pregnant women with pre-labor rupture of membranes.

6. 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 ...