Inpatient Versus Outpatient Cervical Ripening
Stopped early · Not applicable
Conditions studied: Pregnancy Related, Labor, Induction, Cervical Ripening
In brief
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 vagina) must dilate (open) in order to allow passage of the baby into the vagina and through the birth canal. A process called "cervical ripening" is often performed prior to labor induction to prepare the cervix for labor and therefore shorten the length of the labor. There are various pharmacologic and mechanical methods of cervical ripening that result in the physical softening and distensibility of the cervix. Mechanical dilation with a small balloon (i.e. a Foley catheter) placed in the cervix is one of the most commonly used, safe, inexpensive, and effective methods to achieve cervical ripening. In most hospitals, cervical ripening is performed in the hospitals; however, some hospitals allow women to undergo cervical ripening at home with a transcervical Foley catheter. The goal of this study is to compare the use of a Foley catheter for cervical ripening in the inpatient (in-hospital) and outpatient (at home) settings. We anticipate that outpatient use will lead to a shorter amount of time that a woman spends in the hospital, decreased cost, and good patient satisfaction.
Key facts
- Study ID
- NCT03769610
- Run by
- LifeBridge Health
- People needed
- 30
- Starts
- 2017-01-04
- Expected to finish
- 2021-04-01
- Last updated by the study team
- 2021-04-14
Who can join
Age: 14 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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