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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorEastern Virginia Medical School

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Spontaneous labor

Known allergy to latex;

Cervical dilation >2cm;

Chorioamnionitis;

Trial design

Treatments tested in this trial

  • Oxytocin plus Foley Catheter
  • Oxytocin

Treatment groups

80 Participants
are divided into 2 treatment groups