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

RecruitingPhase 4Ages 18 Years - 50 YearsFemaleEastern Virginia Medical School
NCT07119398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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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What it tests

  • Oxytocin plus Foley Catheter
  • Oxytocin
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Where

1 site
Sentara Norfolk General Hospital
Norfolk, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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