Status:
TERMINATED
A Trial of Cervidil for Outpatient Pre-induction of Cervical Ripening
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Induction of Labor Affected Fetus / Newborn
Eligibility:
FEMALE
18-41 years
Phase:
PHASE3
Brief Summary
Induction of labor is a frequently planned obstetric procedure. Induction for women with an unfavorable cervix (bishop score \<6) increases the risk of cesarean section. This risk may be reduced by ri...
Eligibility Criteria
Inclusion
- Accurate gestational age dating by Intermountain dating criteria placing the patient between 39 0/7 and 41 6/7 weeks gestational at time of cervical ripening
- Planning to undergo cervical ripening for induction of labor
- Participants must live \<20 minutes away from the enrolling facility, or must stay \< 20 minutes away.
- Pregnant women between the ages of 18 and 41 at the time of enrollment.
- Fetus in vertex position
Exclusion
- Gestational age \< 39 weeks or \> 41 weeks and 6 days
- Hypertension (chronic, transitional, gestational, preeclampsia)
- Multiple gestation
- Intrauterine Growth Restriction
- Anticoagulant therapy or at high risk for thromboembolism
- Cardiac disease other than class I per American Heart Association (AHA)
- Prior incision in the contractile portion of the uterus
- Placenta previa
- Oligohydramnios per American College of Obstetricians and Gynecologists (ACOG) criteria: AFI \< 5 or deepest vertical pocket \<= 2
- Polyhydramnios per ACOG criteria: Amniotic Fluid Index (AFI) \>= 24
- Cervical dilation \>= 3cm
- Known fetal anomaly that would require advanced neonatal care
- Pitocin-induction of labor is otherwise contraindicated
- Patient is receiving other uterotonics (e.g. oxytocin, Cytotec, etc.)
- Fetal distress
- Unexplained vaginal bleeding during the pregnancy
- Sensitivity to prostaglandin
- Evidence of or suspicion of marked cephalo-pelvic disproportion (per the Cervidil package insert revision 02/2016, Ferring Pharmaceuticals Inc. Parsippany, NJ)
Key Trial Info
Start Date :
August 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03806231
Start Date
August 7 2019
End Date
April 11 2020
Last Update
September 5 2021
Active Locations (1)
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1
Dixie Regional Medical Center
St. George, Utah, United States, 84790