Status:
TERMINATED
Inpatient Versus Outpatient Cervical Ripening
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Thomas Jefferson University
Conditions:
Pregnancy Related
Labor
Eligibility:
FEMALE
14-45 years
Phase:
NA
Brief Summary
Induction of labor is a process of stimulating uterine contractions before the onset of labor, with a goal of achieving vaginal birth. The cervix (the lower part of the uterus that connects to the vag...
Detailed Description
From 1990 to 2010, the rates of induction of labor increased from 9.6% to 23.8%(1). Recent data from 2014 reports a rate of 23.2%(2). Labor induction may be medically indicated, in cases in which the ...
Eligibility Criteria
Inclusion
- Pregnancies at least 37 weeks' gestation, undergoing induction of labor, with an unfavorable cervix, defined as a Bishop score ≤ 6
- The fetus must be in the cephalic presentation
- Indications for induction of labor include, but are not limited to, the following:
- Elective induction of labor at 39 weeks' gestation
- Intrauterine growth restriction
- Chronic hypertension
- Diabetes
- Gestational diabetes
- Prior stillbirth
- Other medical indications for induction of labor, as deemed appropriate by the obstetric provider, such as Systemic Lupus Erythematosus, Cholestasis of Pregnancy etc.
Exclusion
- Gestational hypertension
- Preeclampsia
- Non-reassuring fetal testing
- Multi-fetal gestation
- Oligohydramnios
- Fetal anomaly
- Less than 37 weeks
- Bishop score \> 6
- Ruptured membranes
- Contraindication to vaginal delivery including: active Herpes lesion, HIV VL \>1000 copies/mL, placenta previa, vasa previa, breech presentation, prior classical cesarean section or transfundal myomectomy
- Poor access to telephone or transportation
- Latex allergy
- Any other condition for which the managing physician or investigator deem outpatient management inappropriate.
- Currently participating in another clinical trial
Key Trial Info
Start Date :
January 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03769610
Start Date
January 4 2017
End Date
April 1 2021
Last Update
April 14 2021
Active Locations (2)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21224
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107