Trial · Interventional

RecruitingPhase 4Registry data

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

NCTNCT07119398Other id24-04-FB-0086

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 80 participants (estimated)
Sponsor: Eastern Virginia Medical School · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 14 Jul 2025
Primary completion: 30 Jul 2026 (estimated)
Completion: 30 Dec 2026 (estimated)
First posted: 13 Aug 2025
Last update posted: 13 Aug 2025
Conditions: Preterm PROM (Pregnancy)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 4
Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM
NCT07119398
14 Jul 2025 to est. 30 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Oxytocin plus Foley CatheterCombination product
OxytocinDrug

Arms2

Experimental
Oxytocin plus Foley
• Induction of labor with intravenous oxytocin and a transcervical Foley catheter
Active comparator
Oxytocin Only
• Induction of labor with intravenous oxytocin

Primary outcomes1

Outcomes the sponsor listed as primary.

Vaginal Delivery within 12 Hours
Time frame · 12 hours
Registry description
Vaginal Delivery within 12 hours of induction

Secondary outcomes(19)

Vaginal Delivery Rate
Time frame · From enrollment until delivery
Registry description
Overall vaginal delivery rate
Intraamniotic Infection
Time frame · Enrollment through 6 weeks postpartum
Operative vaginal delivery
Time frame · From enrollment until delivery
Cesarean delivery
Time frame · From enrollment until delivery
Estimated and quantitative blood loss
Time frame · From enrollment until hospital discharge (up to 5 days post-delivery).
Blood transfusion
Time frame · From enrollment until hospital discharge (up to 5 days post-delivery)
Maternal morbidity and adverse maternal outcomes
Time frame · From enrollment until 6 weeks postpartum
Registry description
Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death
Antepartum, intrapartum, or neonatal death
Time frame · From enrollment until 6 weeks postpartum
Suspected and confirmed neonatal sepsis
Time frame · From delivery until hospital discharge (up to 5 days post-delivery)
Birth weight
Time frame · Recorded day of delivery
Hypoglycemia (glucose &lt; 35 mg/dl) requiring IV glucose therapy
Time frame · From birth until hospital discharge (up to 5 days post-delivery)
Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours
Time frame · From birth until 72 hours after delivery
Neonatal encephalopathy
Time frame · From birth until hospital discharge (up to 5 days after delivery)
Registry description
As defined by the NICHD Neonatal Research Network criteria
Seizures
Time frame · From birth until hospital discharge (up to 5 days post-delivery)
Shoulder dystocia
Time frame · Recorded day of delivery
Birth trauma
Time frame · Recorded day of delivery
Registry description
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Intracranial hemorrhage
Time frame · From birth until hospital discharge (up to 5 days post-delivery)
Registry description
Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Time frame · From birth until hospital discharge (up to 5 days post-delivery)
NICU admission
Time frame · From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

More studies

6 studies on this page

Indexing hint: Observational study · 2024

Combination Foley Catheter-Oxytocin versus Oxytocin Alone following Preterm Premature Rupture of Membranes.

Gomez Slagle et al. 2024American journal of perinatologycited by 3

PMID 37793430DOI 10.1055/a-2185-4102PUB-37793430

Rights unknown

Source link

Indexing hint: Randomized controlled trial · 2018

Corrected

Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

Mackeen et al. 2018Obstetrics and gynecologycited by 30

PMID 29215519DOI 10.1097/aog.0000000000002374PUB-29215519

Full text at the publisher

Publisher page Read the notice

Indexing hint: Randomized controlled trial · 2017

A randomized trial of Foley Bulb for Labor Induction in Premature Rupture of Membranes in Nulliparas (FLIP).

Amorosa et al. 2017American journal of obstetrics and gynecologycited by 35

PMID 28479288DOI 10.1016/j.ajog.2017.04.038PUB-28479288

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2017

Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial.

Schoen et al. 2017Obstetrics and gynecologycited by 33

PMID 28486381DOI 10.1097/aog.0000000000002032PUB-28486381

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2016

Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial.

Levine et al. 2016Obstetrics and gynecologycited by 107

PMID 27824758PMC5127406DOI 10.1097/aog.0000000000001778PUB-27824758

Rights unknown

Source link

Indexing hint: Meta-analysis (pooled) · 2005

Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis.

Lin et al. 2005Obstetrics and gynecologycited by 34

PMID 16135593DOI 10.1097/01.aog.0000172425.56840.57PUB-16135593

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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