AzTrials
AzTrials

Preterm PROM (Pregnancy)Phase 4NCT07119398

Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM

A Phase 4 study testing Oxytocin plus Foley Catheter and Oxytocin in people with Preterm PROM (Pregnancy), run by Eastern Virginia Medical School at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Data on the optimal mode of labor induction after preterm prelabor rupture of membranes (PPROM) is lacking. Studies have shown no difference between oxytocin and misoprostol use for labor induction in this cohort (1). Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Preterm PROM (Pregnancy)
What is being tested?
Oxytocin plus Foley Catheter and Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
14 Jul 2025to 30 Dec 2026
Phase
Phase 4
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients 18-50 years of age;
  • The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
  • PPROM;
  • Cervical dilation </= 2cm
  • Fetal cephalic presentation;
  • The patient is between 34 weeks 0 days and 36 weeks 6 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.

Who cannot join

  • Spontaneous labor
  • Known allergy to latex;
  • Cervical dilation >2cm;
  • Chorioamnionitis;
  • Contraindications to induction of labor or use of Foley for cervical ripening
  • HIV
  • Known or suspected fetal anomaly or aneuploidy;
  • Prisoners.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristin Ayers, MPH contact

7574460529

ayerskl@evms.edu

United States1 site, 1 recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Marwan Ma'ayeh, MD, 757-446-7900, maayehmg@odu.edu

    Recruiting

Other trials in United States

About this study

Official title: Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes

Data on the optimal mode of labor induction after preterm prelabor rupture of membranes (PPROM) is lacking. Studies have shown no difference between oxytocin and misoprostol use for labor induction in this cohort (1). The preponderance of evidence from term pregnancies suggests that Foley catheter coupled with oxytocin is better than oxytocin alone, with a higher rate of delivery within 24 hours when a Foley catheter followed by oxytocin is compared to oxytocin alone. However, the use of a Foley catheter has not been evaluated in prospective studies on patients with PPROM.

Being tested
Oxytocin plus Foley Catheter, Oxytocin
Keywords
Induction, PPROM, Preterm prelabor rupture of membranes
Medical subject headings
Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes

What participants receive

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

  • Oxytocin plus Foley CatheterCombination product

    Intravenous oxytocin and a transcervical Foley catheter

  • OxytocinDrug

    Intravenous oxytocin

Study groups in NCT07119398
Study groupRoleWhat they receive
Oxytocin plus FoleyExperimental• Induction of labor with intravenous oxytocin and a transcervical Foley catheter
Receives: Combination Product: Oxytocin plus Foley Catheter
Oxytocin OnlyActive comparator• Induction of labor with intravenous oxytocin
Receives: Drug: Oxytocin

What is being measured

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

  1. Vaginal Delivery within 12 Hours

    Vaginal Delivery within 12 hours of induction

    Measured: 12 hours

Secondary outcomes (19)

  1. Vaginal Delivery Rate

    Overall vaginal delivery rate

    Measured: From enrollment until delivery

  2. Intraamniotic Infection

    Measured: Enrollment through 6 weeks postpartum

  3. Operative vaginal delivery

    Measured: From enrollment until delivery

  4. Cesarean delivery

    Measured: From enrollment until delivery

  5. Estimated and quantitative blood loss

    Measured: From enrollment until hospital discharge (up to 5 days post-delivery).

  6. Blood transfusion

    Measured: From enrollment until hospital discharge (up to 5 days post-delivery)

  7. Maternal morbidity and adverse maternal outcomes

    Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death

    Measured: From enrollment until 6 weeks postpartum

  8. Antepartum, intrapartum, or neonatal death

    Measured: From enrollment until 6 weeks postpartum

  9. Suspected and confirmed neonatal sepsis

    Measured: From delivery until hospital discharge (up to 5 days post-delivery)

  10. Birth weight

    Measured: Recorded day of delivery

  11. Hypoglycemia (glucose &amp;lt; 35 mg/dl) requiring IV glucose therapy

    Measured: From birth until hospital discharge (up to 5 days post-delivery)

  12. Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours

    Measured: From birth until 72 hours after delivery

  13. Neonatal encephalopathy

    As defined by the NICHD Neonatal Research Network criteria

    Measured: From birth until hospital discharge (up to 5 days after delivery)

  14. Seizures

    Measured: From birth until hospital discharge (up to 5 days post-delivery)

  15. Shoulder dystocia

    Measured: Recorded day of delivery

  16. Birth trauma

    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy

    Measured: Recorded day of delivery

  17. Intracranial hemorrhage

    Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma

    Measured: From birth until hospital discharge (up to 5 days post-delivery)

  18. Hyperbilirubinemia requiring phototherapy or exchange transfusion

    Measured: From birth until hospital discharge (up to 5 days post-delivery)

  19. NICU admission

    Measured: From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first

Timeline

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

  1. First posted13 Aug 2025
  2. Study start14 Jul 2025
  3. Primary completion30 Jul 2026 (estimated)
  4. Study completion30 Dec 2026 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a non-blinded prospective randomized pilot trial of pregnant patients with a singleton pregnancy between 34 weeks 0 days and 36 weeks 6 days gestation with PPROM receiving an induction of labor. Participants will be randomized to either: * Induction of labor with intravenous oxytocin * Induction of labor with intravenous oxytocin and a transcervical Foley catheter
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119398
Sponsor's protocol ID
24-04-FB-0086
Status last verified
Aug 2025
First submitted
21 Jul 2025
Last updated
13 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.

    PubMed 26244535

  • Gomez Slagle HB, Hoffman MK, Sciscione AC, Ma'ayeh M. Combination Foley Catheter-Oxytocin versus Oxytocin Alone following Preterm Premature Rupture of Membranes. Am J Perinatol. 2024 May;41(S 01):e3030-e3034. doi: 10.1055/a-2185-4102. Epub 2023 Oct 4.

    PubMed 37793430

  • Amorosa JMH, Stone J, Factor SH, Booker W, Newland M, Bianco A. A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP). Am J Obstet Gynecol. 2017 Sep;217(3):360.e1-360.e7. doi: 10.1016/j.ajog.2017.04.038. Epub 2017 May 4.

    PubMed 28479288

  • Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.

    PubMed 29215519

  • Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.

    PubMed 27824758

  • Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.

    PubMed 28486381

  • Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57.

    PubMed 16135593

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxytocin plus Foley Catheter and Oxytocin in people with Preterm PROM (Pregnancy), run by Eastern Virginia Medical School 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Kristin Ayers, MPH (7574460529, ayerskl@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaginal Delivery within 12 Hours (time frame: 12 hours). 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 NCT07119398, which also lists 7 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 13 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in