Preterm PROM (Pregnancy)
Conditions
Keywords
Induction, PPROM, Preterm prelabor rupture of membranes
Brief summary
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_PRODUCTOxytocin plus Foley Catheter
Intravenous oxytocin and a transcervical Foley catheter
DRUGOxytocin
Intravenous oxytocin
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a non-blinded prospective randomized pilot trial of pregnant patients with a singleton pregnancy between 34 weeks 0 days and 36 weeks 6 days gestation with PPROM receiving an induction of labor. Participants will be randomized to either: * Induction of labor with intravenous oxytocin * Induction of labor with intravenous oxytocin and a transcervical Foley catheter
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Delivery within 12 Hours | 12 hours | Vaginal Delivery within 12 hours of induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraamniotic Infection | Enrollment through 6 weeks postpartum | — |
| Operative vaginal delivery | From enrollment until delivery | — |
| Cesarean delivery | From enrollment until delivery | — |
| Estimated and quantitative blood loss | From enrollment until hospital discharge (up to 5 days post-delivery). | — |
| Blood transfusion | From enrollment until hospital discharge (up to 5 days post-delivery) | — |
| Maternal morbidity and adverse maternal outcomes | From enrollment until 6 weeks postpartum | Including endometritis / chorioamnionitis, wound infection, venous thromboembolism, massive transfusion and postpartum hemorrhage, ICU admission, and maternal death |
| Antepartum, intrapartum, or neonatal death | From enrollment until 6 weeks postpartum | — |
| Suspected and confirmed neonatal sepsis | From delivery until hospital discharge (up to 5 days post-delivery) | — |
| Birth weight | Recorded day of delivery | — |
| Vaginal Delivery Rate | From enrollment until delivery | Overall vaginal delivery rate |
| Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours | From birth until 72 hours after delivery | — |
| Neonatal encephalopathy | From birth until hospital discharge (up to 5 days after delivery) | As defined by the NICHD Neonatal Research Network criteria |
| Seizures | From birth until hospital discharge (up to 5 days post-delivery) | — |
| Shoulder dystocia | Recorded day of delivery | — |
| Birth trauma | Recorded day of delivery | Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy |
| Intracranial hemorrhage | From birth until hospital discharge (up to 5 days post-delivery) | Intraventricular hemorrhage, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma |
| Hyperbilirubinemia requiring phototherapy or exchange transfusion | From birth until hospital discharge (up to 5 days post-delivery) | — |
| NICU admission | From birth until time of NICU admission or hospital discharge (up to 5 days post-delivery), whichever comes first | — |
| Hypoglycemia (glucose &lt; 35 mg/dl) requiring IV glucose therapy | From birth until hospital discharge (up to 5 days post-delivery) | — |
Countries
United States
Contacts
Primary ContactKristin Ayers, MPH
Outcome results
None listed