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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin plus Foley | Experimental | • Induction of labor with intravenous oxytocin and a transcervical Foley catheter |
|
| Oxytocin Only | Active Comparator | • Induction of labor with intravenous oxytocin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin plus Foley Catheter | Combination Product | Intravenous oxytocin and a transcervical Foley catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Delivery within 12 Hours | Vaginal Delivery within 12 hours of induction | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Delivery Rate | Overall vaginal delivery rate | From enrollment until delivery |
| Intraamniotic Infection | Enrollment through 6 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Ayers, MPH | Contact | 7574460529 | ayerskl@evms.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marwan Ma'ayeh, MD | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26244535 | Background | 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. | |
| 37793430 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2025 | Jul 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2025 | Jul 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005322 | Fetal Membranes, Premature Rupture |
| C563032 | Preterm Premature Rupture of the Membranes |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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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:
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| Oxytocin | Drug | Intravenous oxytocin |
|
| Operative vaginal delivery | From enrollment until delivery |
| Cesarean delivery | From enrollment until delivery |
| Estimated and quantitative blood loss | From enrollment until hospital discharge (up to 5 days post-delivery). |
| Blood transfusion | 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 | From enrollment until 6 weeks postpartum |
| Antepartum, intrapartum, or neonatal death | From enrollment until 6 weeks postpartum |
| Suspected and confirmed neonatal sepsis | From delivery until hospital discharge (up to 5 days post-delivery) |
| Birth weight | Recorded day of delivery |
| Hypoglycemia (glucose < 35 mg/dl) requiring IV glucose therapy | 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 | From birth until 72 hours after delivery |
| Neonatal encephalopathy | As defined by the NICHD Neonatal Research Network criteria | From birth until hospital discharge (up to 5 days after delivery) |
| Seizures | From birth until hospital discharge (up to 5 days post-delivery) |
| Shoulder dystocia | Recorded day of delivery |
| Birth trauma | Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy | Recorded day of delivery |
| Intracranial hemorrhage | Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma | From birth until hospital discharge (up to 5 days post-delivery) |
| Hyperbilirubinemia requiring phototherapy or exchange transfusion | From birth until hospital discharge (up to 5 days post-delivery) |
| NICU admission | From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first |
| 28479288 | Background | 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. |
| 29215519 | Background | 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. |
| 27824758 | Background | 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. |
| 28486381 | Background | 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. |
| 16135593 | Background | 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. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |