A Phase 4 interventional study of Oxytocin plus Foley Catheter and Oxytocin in Preterm PROM (Pregnancy), sponsored by Eastern Virginia Medical School. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Eastern Virginia Medical School · Phase 4, Interventional, and Treatment
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.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
This study's planned enrollment of 80 is below the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.
Browse Fetal Membranes, Premature Rupture studies →Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
• Induction of labor with intravenous oxytocin and a transcervical Foley catheter
Combination Product: Oxytocin plus Foley Catheter
• Induction of labor with intravenous oxytocin
Drug: Oxytocin
Intravenous oxytocin and a transcervical Foley catheter
Intravenous oxytocin
Vaginal Delivery within 12 Hours
Vaginal Delivery within 12 hours of induction
Time frame: 12 hours
Vaginal Delivery Rate
Overall vaginal delivery rate
Time frame: From enrollment until delivery
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
Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death
Time frame: From enrollment until 6 weeks postpartum
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 < 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
As defined by the NICHD Neonatal Research Network criteria
Time frame: From birth until hospital discharge (up to 5 days after delivery)
Seizures
Time frame: From birth until hospital discharge (up to 5 days post-delivery)
Shoulder dystocia
Time frame: Recorded day of delivery
Birth trauma
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Time frame: Recorded day of delivery
Intracranial hemorrhage
Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Time frame: From birth until hospital discharge (up to 5 days post-delivery)
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Jul 2026, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fetal Membranes, Premature Rupture →
Eastern Virginia Medical School