Pregnancy OutcomeBalloonNCT05506631
Foley Balloon Study for Cervical Ripening - Cost Comparison Between Outpatient and Inpatient Cervical Ripening
A study testing Outpatient Foley balloon placement and Inpatient Foley Balloon placement in people with Pregnancy Outcome, run by Lehigh Valley Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Outcome
- What is being tested?
- Outpatient Foley balloon placement and Inpatient Foley Balloon placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105
About this study
Official title: Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term
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.
Read the detailed description
The objective of the 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.
Specific Aims
In conducting this study, the investigators will accomplish the following specific aim:
To compare the length of inpatient care for women undergoing cervical ripening with a transcervical Foley placed in the outpatient vs. inpatient setting prior to induction of labor.
- Primary outcomes of interest
- 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.
Outpatient arm:
Time for the participants in the outpatient group will be measured from the time the participant is admitted to the hospital for induction of labor until she delivers.
Inpatient arm:
Time for the participant in the inpatient group will be measured from the time the participant is admitted to the hospital for cervical ripening with balloon placement and induction until she delivers.
Time from admission to L\&D until delivery = total INPATIENT until delivery (hours)
- Cost Analysis
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 participant spends in outpatient care, inpatient care, hospitalized from admission to the L\&D unit to delivery.
The investigators will report on the delta/difference in average costs of outpatient and inpatient care between the outpatient and inpatient arms of the study.
Information will be obtained from the finance department at LVHN.
- Secondary outcomes of interest to be compared by randomization groups include:
- maternal outcomes
- mode of delivery, chorioamnionitis, endometritis, placental abruption, urinary tract infection, preeclampsia, wound infection, venous thromboembolism, maternal treatment with postpartum antibiotics
- neonatal outcomes
- neonatal birthweight, Apgar scores, admission to the neonatal intensive care unit (ICU), neonatal ICU length of stay, neonatal hypoglycemia, neonatal sepsis, neonatal seizures, meconium aspiration, intubation for respiratory support, neonatal length of stay (total), umbilical cord gas pH, neonatal death or stillbirth
- dosing of narcotic medications before regional anesthesia
- total oxytocin infusion dosing
- total length of stay for mothers and neonates
- Conditions
- Pregnancy Outcome
- Being tested
- Outpatient Foley balloon placement, Inpatient Foley Balloon placement
- Keywords
- cervical Ripening, Labor, induced, Term Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Foley balloon placementProcedure or surgery
Cervical ripening with balloon placement in the outpatient setting
Inpatient Foley Balloon placementProcedure or surgery
Cervical ripening with balloon placement in the inpatient setting
| Study group | Role | What they receive |
|---|---|---|
| Outpatient cervical ripening | Experimental | Placement of transcervical Foley balloon for cervical ripening in outpatient setting Receives: Procedure: Outpatient Foley balloon placement |
| Inpatient cervical ripening | Active comparator | Placement of transcervical Foley balloon for cervical ripening in inpatient setting Receives: Procedure: Inpatient Foley Balloon placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (12)
Delivery
Mode of Delivery
Measured: 12 months
Maternal state
Maternal outcomes
Measured: 12 months
Neonatal State
Neonatal outcomes
Measured: 12 months
Maternal Adverse events
Maternal Adverse events such as chorioamnionitis; endometritis; placental abruption; urinary tract infection; preeclampsia,; wound infection; venous thromboembolism; need for post partum antibiotics
Measured: 12 months
Neonatal adverse events
Neonatal Adverse events such as: hypoglycemia; sepsis; seizures; meconium aspiration; respiratory failure; death
Measured: 12 months
Birthweight
neonatal birthweight in kilograms
Measured: 12 months
ICU Length of stay
neonatal ICU length of stay in days
Measured: 12 months
Total Length of stay
neonatal Inpatient length of stay in days
Measured: 12 months
Cord PH
Umbilical cord gas PH as reported
Measured: 12 months
Narcotic dosing
Maternal dosing of narcotic medications before regional anesthesia
Measured: 12 months
Oxytocin dosing
Oxytocin dose per unit
Measured: 12 months
Maternal length of stay
Maternal inpatient length of stay in days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Nov 2021
- Primary completion30 May 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Quinones, MD, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506631
- Sponsor's protocol ID
- 00000949
- Acronym
- Balloon
- Status last verified
- May 2025
- First submitted
- 8 Dec 2021
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term
- ClinicalTrials.gov ID
- NCT05506631
- Acronym / sponsor ID
- Balloon / 00000949
- Conditions
- Pregnancy Outcome
- Keywords
- cervical Ripening, Labor, induced, Term Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of the 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.
Specific Aims
In conducting this study, the investigators will accomplish the following specific aim:
To compare the length of inpatient care for women undergoing cervical ripening with a transcervical Foley placed in the outpatient vs. inpatient setting prior to induction of labor.
- Primary outcomes of interest
- 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.
Outpatient arm:
Time for the participants in the outpatient group will be measured from the time the participant is admitted to the hospital for induction of labor until she delivers.
Inpatient arm:
Time for the participant in the inpatient group will be measured from the time the participant is admitted to the hospital for cervical ripening with balloon placement and induction until she delivers.
Time from admission to L\&D until delivery = total INPATIENT until delivery (hours)
- Cost Analysis
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 participant spends in outpatient care, inpatient care, hospitalized from admission to the L\&D unit to delivery.
The investigators will report on the delta/difference in average costs of outpatient and inpatient care between the outpatient and inpatient arms of the study.
Information will be obtained from the finance department at LVHN.
- Secondary outcomes of interest to be compared by randomization groups include:
- maternal outcomes
- mode of delivery, chorioamnionitis, endometritis, placental abruption, urinary tract infection, preeclampsia, wound infection, venous thromboembolism, maternal treatment with postpartum antibiotics
- neonatal outcomes
- neonatal birthweight, Apgar scores, admission to the neonatal intensive care unit (ICU), neonatal ICU length of stay, neonatal hypoglycemia, neonatal sepsis, neonatal seizures, meconium aspiration, intubation for respiratory support, neonatal length of stay (total), umbilical cord gas pH, neonatal death or stillbirth
- dosing of narcotic medications before regional anesthesia
- total oxytocin infusion dosing
- total length of stay for mothers and neonates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Outpatient cervical ripening | Experimental | Procedure: Outpatient Foley balloon placementPlacement of transcervical Foley balloon for cervical ripening in outpatient setting |
| Inpatient cervical ripening | Active comparator | Procedure: Inpatient Foley Balloon placementPlacement of transcervical Foley balloon for cervical ripening in inpatient setting |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient Foley balloon placementCervical ripening with balloon placement in the outpatient setting | Procedure or surgery | Outpatient cervical ripening |
| Inpatient Foley Balloon placementCervical ripening with balloon placement in the inpatient setting | Procedure or surgery | Inpatient cervical ripening |
Primary outcome
The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.
Time frame: 12 months
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.
Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.
Time frame: 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 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 secondary outcomes
Delivery
Time frame: 12 months
Maternal state
Time frame: 12 months
Neonatal State
Time frame: 12 months
Maternal Adverse events
Time frame: 12 months
Neonatal adverse events
Time frame: 12 months
Birthweight
Time frame: 12 months
ICU Length of stay
Time frame: 12 months
Total Length of stay
Time frame: 12 months
Cord PH
Time frame: 12 months
Narcotic dosing
Time frame: 12 months
Oxytocin dosing
Time frame: 12 months
Maternal length of stay
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Foley balloon placement and Inpatient Foley Balloon placement in people with Pregnancy Outcome, run by Lehigh Valley Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025; AzTrials last refreshed its copy on 1 Nov 2026.