Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening
Completed · Not applicable
Conditions studied: Pregnancy Outcome
In brief
The objective of this study is to determine the impact of outpatient cervical ripening with transcervical balloon placement for induction of labor at term on the length and cost of inpatient hospitalization when compared to inpatient cervical ripening.
Key facts
- Study ID
- NCT05506631
- Run by
- Lehigh Valley Hospital
- People needed
- 140
- Starts
- 2021-11-01
- Expected to finish
- 2024-10-30
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older, up to 39. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women at ≥39 weeks gestation by reliable dating criteria as determined by the American College of Obstetricians and Gynecologists
- Scheduled induction of labor with indication and timing supported by Lehigh Valley Health Network -Labor and Delivery Units (Cedar Crest \& Muhlenberg)
- Singleton gestation
- Cephalic presentation
- Amniotic fluid index normal
- Formal prenatal ultrasound during the pregnancy documenting the absence of placenta previa
- Bishop score <6 and cervical dilation <3cm at the time of decision to induce labor
- The woman is able to give appropriate consent and has undergone an informed consent process.
- Maternal age ≥ 18 years old at the time of consent
- English speaking
You may not qualify if…
- Undergoing outpatient antenatal testing for any medical or obstetric condition
- Need for inpatient observation or continuous fetal monitoring during their cervical ripening
- New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy)
- Vaginal bleeding
- Active labor
- Premature rupture of membranes
- Uterine tachysystole (>5 contractions in 10 minutes)
- Non-reassuring fetal heart tracing before Foley placement
- Intrauterine fetal demise diagnosed after enrollment and before placement of balloon
- Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery)
- Abnormal placentation including a low lying placenta
- Prior cesarean delivery
- Known fetal major anomaly
- Human immunodeficiency virus, Hepatitis C, or active herpes infection
- Maternal cardiopulmonary disease requiring cardiac monitoring during labor
- Pregestational diabetes or GDMA2
- Rh isoimmunization
- Non-English speaking
- BMI > 40
- Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation
Where it is running
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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