Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Outpatient cervical ripening
Placement of transcervical Foley balloon for cervical ripening in outpatient setting
干预措施: Outpatient Foley balloon placement (Procedure)
Inpatient cervical ripening
Placement of transcervical Foley balloon for cervical ripening in inpatient setting
干预措施: Inpatient Foley Balloon placement (Procedure)
结局指标
主要结局
Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.
时间窗: 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.
The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.
时间窗: 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.
次要结局
- ICU Length of stay(12 months)
- Total Length of stay(12 months)
- Cord PH(12 months)
- Birthweight(12 months)
- Narcotic dosing(12 months)
- Oxytocin dosing(12 months)
- Delivery(12 months)
- Neonatal adverse events(12 months)
- Maternal state(12 months)
- Neonatal State(12 months)
- Maternal Adverse events(12 months)
- Maternal length of stay(12 months)
研究者
Joanne Quinones, MD
Vice Chair Research, Dept OBGYN, Lehigh Valley Health Network
Lehigh Valley Hospital