Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Total time from admission to delivery
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).
Detailed Description
Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to "ready" the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery. Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own home. The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge from the hospital.
Investigators
Elizabeth B. Ausbeck
Fellow, Maternal-Fetal Medicine
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •Nulliparous
- •Singleton gestation
- •Gestational age between 39+0 and 42+0 weeks
- •Vertex presentation
- •Modified Bishop score \<5 and cervical dilation ≤ 2 cm
- •No prior cesarean or prior uterine surgery
- •Resides within 30 minutes of UAB Hospital
- •Access to a telephone
- •Reliable transportation
Exclusion Criteria
- •Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
- •Latex allergy
- •Contraindication to induction of labor
- •Evidence of labor
- •Fetal demise
- •Fetal anomaly
- •Inability to give consent (e.g., inability to read or write)
Outcomes
Primary Outcomes
Total time from admission to delivery
Time Frame: From baseline to the time of delivery (baseline is from admission)
Secondary Outcomes
- Modified Bishop score on admission(At baseline)
- Evaluation of patient satisfaction with care(Within 2-4 days after delivery)
- Rates of spontaneous rupture of membranes between Foley bulb placement and admission(From placement of Foley bulb to 24 hours)
- Total time of oxytocin infusion(From baseline to delivery)
- Maximum oxytocin rate(From baseline to delivery)
- Evaluation of patient experience on labor and delivery(Within 2-4 days after delivery)
- Rates of umbilical cord artery pH <7.1(From time of delivery up to 5 minutes post-delivery)
- Rates of umbilical cord artery base deficit <-12(From time of delivery up to 5 minutes post-delivery)
- Evaluation of pain experienced during childbirth(From placement of Foley bulb to delivery)
- Vaginal bleeding greater than bloody show(From placement of Foley bulb to delivery)
- Total hospital duration(From hospital admission to hospital discharge (generally less than one week))
- Rates of calls to the obstetrical triage unit(From placement of Foley bulb to 24 hours)
- Total duration of time of neuraxial anesthesia use(From baseline to delivery)
- Rates of acetaminophen use(From placement of Foley bulb to 24 hours)
- Highest maternal intrapartum temperature(From baseline to delivery)
- Rates of chorioamnionitis(From baseline to delivery)
- Rates of endometritis(From delivery until 30 days post-discharge)
- Mode of delivery(From baseline to delivery)
- Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time(From placement of Foley bulb to 24 hours)
- Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement(From placement of Foley bulb to 30 minutes)
- Rates of hospital readmission within 30 days(From hospital discharge until 30 days post-discharge)
- Rates of 5-minute Apgar score <7(From time of delivery up to 5 minutes post-delivery)
- Rates of neonatal intensive care unit admissions(After delivery and before neonatal discharge (generally less than one week))
- Postpartum hemorrhage(At delivery)