Status:
COMPLETED
Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
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 object...
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...
Eligibility Criteria
Inclusion
- Age ≥ 18
- 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
- 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)
Key Trial Info
Start Date :
May 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03472937
Start Date
May 4 2018
End Date
December 13 2019
Last Update
February 6 2020
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233