Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cerv… (NCT05506631) | Clinical Trial Compass
CompletedNot Applicable
Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening
United States140 participantsStarted 2021-11-01
Plain-language summary
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.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 delive…
What they're measuring
1
The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.
Timeframe: 12 months
2
Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.