Status:
WITHDRAWN
Cervical Ripening With Foley Bulb Versus Dilapan-S at Home
Lead Sponsor:
Christiana Care Health Services
Collaborating Sponsors:
Medicem International CR s.r.o.
Medicem Technology s.r.o.
Conditions:
Induced; Birth
Induction of Labor Affected Fetus / Newborn
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
DILAPAN-S® was FDA-approved for pre-induction cervical ripening in 2015. Since that time, there have been limited studies comparing its efficacy, safety, and patient satisfaction to other mechanical c...
Detailed Description
In 2019, Grobman et al, published the ARRIVE trial showing that labor inductions without medical indication at 39 weeks gestation are associated with improved maternal and perinatal outcomes compared ...
Eligibility Criteria
Inclusion
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically is not eligible unless the reduction occurred before 14 weeks 0 days gestational age.
- Gestational age at randomization between 39 weeks and 40 weeks 6 days (based on reliable EGA defined as ultrasound performed before 14 weeks 0 days, or a certain LMP consistent with ultrasonography before 21 weeks and 0 days.)
- Patient prefers outpatient cervical ripening
- Patient lives within a one-hour commute from the hospital.
Exclusion
- Project gestational age at date of first ultrasound is \> 20 weeks 6 days
- Refusal of blood products
- Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
- Delivery planned elsewhere at a non-Christiana site
- Major maternal medical illness associated with increased risk for adverse pregnancy outcomes that would preclude her from an outpatient induction (e.g. any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
- Medical indication for induction prior to 40 weeks 5 days due to any maternal
- Heparin or low-molecular weight heparin use during the current pregnancy
- Cerclage in current pregnancy
- Prior uterine or cervical surgery (cesarean, myomectomy, cerclage, LEEP, cone biopsy, etc.)
- Known HIV positivity because of modified delivery plan
- Iodine or latex allergy
- Fetal demise or known major fetal anomaly
- Medical indication for induction prior to 40 weeks 5 days due to any fetal condition
- Known oligohydramnios, defined as amniotic fluid index \< 5 cm or maximal vertical pocket \< 2 cm
- Fetal growth restriction, defined as EFW \< 10th percentile
- Plan for cesarean delivery or contraindication to labor
- Nonvertex fetal presentation
- Placenta previa, placenta accrete, or vasa previa
- Active genital herpes lesions
- Cervical dilation greater than 3 cm on initial evaluation
- Signs of labor (regular painful contractions with cervical change) on initial evaluation
- Active vaginal bleeding greater than bloody show on initial evaluation
- Ruptured membranes on initial evaluation
- Non-reassuring fetal status (category II or III fetal heart rate tracing) on initial evaluation
Key Trial Info
Start Date :
June 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04739683
Start Date
June 30 2022
End Date
June 30 2022
Last Update
September 21 2022
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