Health TrialsbyHealthPanel

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

ConditionPreterm PROM (Pregnancy)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Oxytocin plus Foley Catheter

    Combination product

    Intravenous oxytocin and a transcervical Foley catheter

  • Oxytocin

    Drug

    Intravenous oxytocin

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Oxytocin plus FoleyExperimental treatment 1 intervention
Group B: Oxytocin OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vaginal Delivery within 12 Hours

Vaginal Delivery within 12 hours of induction

Time frame
12 hours

Secondary outcomes

1

Vaginal Delivery Rate

Overall vaginal delivery rate

Time frame
From enrollment until delivery
2

Intraamniotic Infection

Time frame
Enrollment through 6 weeks postpartum
3

Operative vaginal delivery

Time frame
From enrollment until delivery
4

Cesarean delivery

Time frame
From enrollment until delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Virginia Medical School

Lead sponsor

Source ClinicalTrials.gov
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