Recruiting NCT07119398
Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxytocin plus Foley Catheter, Oxytocin.
- Who it may be relevant to
- Registry conditions: Preterm PROM (Pregnancy). Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Combination Oxytocin/Foley Versus Oxytocin Alone for Induction of Labor in Patients With Preterm Prelabor Rupture of Membranes
Overview
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
- Combination product Oxytocin plus Foley Catheter
Intravenous oxytocin and a transcervical Foley catheter - Drug Oxytocin
Intravenous oxytocin
Primary outcome measures
- Vaginal Delivery within 12 Hours [Time frame: 12 hours]
Secondary outcome measures (12)
- 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 [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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sentara Norfolk General Hospital — Norfolk
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 16135593
Identifiers
NCT: NCT07119398 · 24-04-FB-0086