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

NCT05506631 | Completed

• 1 other identifier: 00000949
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Outcome

Keywords

cervical Ripening; Labor, induced; Term Birth

Outcome Measures

Primary Outcomes (2)

• The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.

  The length of time (measured in minutes) spent on the inpatient unit (L\&D) from admission for cervical ripening and/or labor induction until delivery.

  12 months

• Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.

  Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups. Cost will be based on information obtained from Enterprise Analytics charges for the time each woman spends in outpatient care, inpatient care, hospitalized from admission to the L\&D unit to delivery.

  12 months

Secondary Outcomes (12)

• Delivery

  12 months

• Maternal state

  12 months

• Neonatal State

  12 months

• Maternal Adverse events

  12 months

• Neonatal adverse events

  12 months

Study Arms (2)

Outpatient cervical ripening

EXPERIMENTAL

Placement of transcervical Foley balloon for cervical ripening in outpatient setting

Procedure: Outpatient Foley balloon placement

Inpatient cervical ripening

ACTIVE COMPARATOR

Placement of transcervical Foley balloon for cervical ripening in inpatient setting

Procedure: Inpatient Foley Balloon placement

Interventions

Outpatient Foley balloon placement PROCEDURE

Cervical ripening with balloon placement in the outpatient setting

Outpatient cervical ripening

Inpatient Foley Balloon placement PROCEDURE

Cervical ripening with balloon placement in the inpatient setting

Inpatient cervical ripening

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Lehigh Valley Hospital: lead

Study Sites (1)

Lehigh Valley Health Network

Allentown, Pennsylvania, 18105, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Research, Dept OBGYN, Lehigh Valley Health Network

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: August 18, 2022
• Study Start: November 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

US (1)