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

Study Overview
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Brief Summary
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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
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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

Official Title
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Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term

Conditions
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Pregnancy Outcome

Intervention / Treatment
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* Procedure: Outpatient Foley balloon placement
* Procedure: Inpatient Foley Balloon placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient cervical ripening<br>Placement of transcervical Foley balloon for cervical ripening in outpatient setting | Procedure: Outpatient Foley balloon placement<br>* Cervical ripening with balloon placement in the outpatient setting<br>|
| Active Comparator: Inpatient cervical ripening<br>Placement of transcervical Foley balloon for cervical ripening in inpatient setting | Procedure: Inpatient Foley Balloon placement<br>* Cervical ripening with balloon placement in the inpatient setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery | Mode of Delivery | 12 months | 
| Maternal state | Maternal outcomes | 12 months | 
| Neonatal State | Neonatal outcomes | 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 | 12 months | 
| Neonatal adverse events | Neonatal Adverse events such as: hypoglycemia; sepsis; seizures; meconium aspiration; respiratory failure; death | 12 months | 
| Birthweight | neonatal birthweight in kilograms | 12 months | 
| ICU Length of stay | neonatal ICU length of stay in days | 12 months | 
| Total Length of stay | neonatal Inpatient length of stay in days | 12 months | 
| Cord PH | Umbilical cord gas PH as reported | 12 months | 
| Narcotic dosing | Maternal dosing of narcotic medications before regional anesthesia | 12 months | 
| Oxytocin dosing | Oxytocin dose per unit | 12 months | 
| Maternal length of stay | Maternal inpatient length of stay in days | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical Ripening, Labor, induced, Term Birth