Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening

Launched by LEHIGH VALLEY HOSPITAL · Aug 17, 2022

Keywords

ClinConnect Summary

The Foley Balloon Study is looking at two different ways to help pregnant women get ready for labor when they are near their due date. Specifically, the study compares the costs and hospital stay lengths between two approaches: one where women stay in the hospital (inpatient) and another where they can go home after the procedure (outpatient) before returning to give birth. The goal is to see if the outpatient method, which uses a special balloon to help soften the cervix, can reduce the time spent in the hospital and lower costs for families.

To participate in this study, women must be at least 18 years old, pregnant for 39 weeks or more, and scheduled to be induced for labor. They should only be carrying one baby, and the baby should be in a head-down position. Women who have certain medical conditions or complications, like high blood pressure or significant bleeding, are not eligible for the study. For those who qualify, they can expect to receive care and support throughout the process, with the aim of making labor induction as smooth and cost-effective as possible. This study is currently recruiting participants, so if you or someone you know might be interested, it’s worth discussing with a healthcare provider.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • 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
• • Exclusion Criteria
• • 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