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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Intravenous oxytocin and a transcervical Foley catheter
Intravenous oxytocin
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
RECRUITINGVaginal Delivery within 12 Hours
Vaginal Delivery within 12 hours of induction
Time frame: 12 hours
Vaginal Delivery Rate
Overall 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
Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death
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
Neonatal encephalopathy
As defined by the NICHD Neonatal Research Network criteria
Time frame: From birth until hospital discharge (up to 5 days after delivery)
Seizures
Time frame: From birth until hospital discharge (up to 5 days post-delivery)
Shoulder dystocia
Time frame: Recorded day of delivery
Birth trauma
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Time frame: Recorded day of delivery
Intracranial hemorrhage
Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Time frame: From birth until hospital discharge (up to 5 days post-delivery)
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Time frame: From birth until hospital discharge (up to 5 days post-delivery)
NICU admission
Time frame: From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first
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