Status:
TERMINATED
Dilapan-S® for Induction of Labor The Feasibility Study
Lead Sponsor:
Albany Medical College
Conditions:
Induction of Labor Affected Fetus / Newborn
Eligibility:
All Genders
Phase:
NA
Brief Summary
This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies \>=39 weeks.
Detailed Description
In 2019, the ARRIVE trial was published, demonstrating that in low risk nulliparous women, induction of labor at 39 weeks was associated with a decreased risk for hypertensive disorders of pregnancy a...
Eligibility Criteria
Inclusion
- Planned induction of labor ≥ 39 weeks
- Singleton gestation
- Vertex presentation
- Cervical dilation \<3cm
Exclusion
- Placenta previa
- Placenta accreta
- Vasa previa
- Preterm prelabor rupture of membranes
- Non-english speaking
- \<18 years old
- Multiple gestation
- Prior cesarean delivery
- Prior myomectomy
- Fetal malpresentation
- Active vaginal bleeding
- Cervical dilation \>1 cm
- Uterine anomaly (didelphysis, bicornuate)
- Intrauterine growth restriction \<10th%
- Fetal anomalies
- Requirements to be inpatient
- Polyhydramnios (AFI\>25cm or MVP\>8cm)
- Chronic hypertension on medications
- Gestational hypertension/preeclampsia
- GDMA2, DM1, DM2
- Hepatitis B or C
- HIV
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04521062
Start Date
August 1 2020
End Date
December 31 2022
Last Update
April 18 2023
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12208