Outpatient Foley for Starting Induction of Labor at Term
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Total Time From Admission to Delivery
研究概览
简要总结
The investigators are performing a randomized controlled-trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. This is a pilot study to establish the efficacy of this method in decreasing time as in inpatient and evaluate patient satisfaction.
详细描述
Induction of labor is necessary in one-fourth of women and a large proportion requires cervical ripening. Cervical ripening is necessary to shorten the time to delivery and increases the chances of a vaginal delivery.
Outpatient cervical ripening is an attractive alternative to women and physicians because of the decreased amount of time spent in the hospital and opportunity for patients to be in the comforts of their home.
The investigators will conduct a randomized controlled trial comparing outpatient to inpatient cervical ripening using a transcervical Foley catheter. Women will be randomized to undergo inpatient or outpatient transcervical Foley catheter cervical ripening beyond their 39th week of gestation. Women and their infants will be followed until the time of their discharge.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Multiparous
- •Singleton gestation
- •Gestational age between 39+0 and 42+0
- •Vertex presentation
- •Cervix ≤ 3 cm. If cervix is between 2 and 3 cm dilated, it must be <80% effaced
- •No prior cesarean section or uterine surgery
- •Resides within Jefferson County, Alabama.
- •Access to a telephone
- •Reliable transportation
排除标准
- •Unsuitable for outpatient Foley placement management (IUGR, oligohydramnios, prior cesarean delivery, gestational hypertension, preeclampsia, or uncontrolled chronic hypertension, complex maternal disease, provider discretion). Any patient with pregestational or gestational diabetes on medications will be excluded.
- •Latex allergy
- •Contraindication to induction of labor
- •Evidence of labor
- •Fetal anomaly or demise
- •Inability to given consent (non-English speaking, inability to read or write)
研究组 & 干预措施
Inpatient cervical Ripening
Subjects in this arm will be seen in the outpatient setting, and if they qualify and are randomized to the inpatient (control) group, they will be admitted to labor and delivery the next day for cervical ripening with a transcervical Foley catheter.
干预措施: Inpatient cervical ripening (Other)
Outpatient cervical Ripening
Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (treatment arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next morning to be admitted to labor and delivery for oxytocin administration.
干预措施: Outpatient cervical ripening (Other)
结局指标
主要结局
Total Time From Admission to Delivery
时间窗: From baseline to the time of delivery (baseline is from admission), up to 7 days
次要结局
- Number of Participants Admitted Prior to the Scheduled Induction of Labor Time(From placement of Foley bulb to 24 hours.)
- Total Duration of Time From Rupture of Membranes Until Delivery(Assessed from baseline to delivery, up to 3 days)
- Number of Participants With Endometritis(Assessed from delivery until 30 days post-discharge.)
- Number of Neonates With a 5-minute Apgar Score Less Than 7(Assessed at time of delivery up to 5-minutes post-delivery.)
- Total Hospital Duration(From admission time to the hospital until discharge from the hospital, up to 7 days)
- Number of Participants Using Acetaminophen(From placement of Foley bulb to 24 hours.)
- Number of Participants Calling the Obstetrical Triage Unit(From placement of Foley bulb to 24 hours.)
- Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission(From placement of Foley bulb to 24 hours.)
- Total Duration of Time of Neuraxial Anesthesia Use(Assessed from baseline to delivery, up to 3 days)
- Maximum Oxytocin Rate(Assessed from baseline to delivery, up to 3 days)
- Highest Maternal Intrapartum Temperature(Assessed from baseline to delivery, up to 3 days)
- Number of Participants With Chorioamnionitis(Assessed from baseline to delivery.)
- Number of Participants Who Had a Cesarean Delivery(Assessed from baseline to delivery.)
- Number of Participants With an Operative Vaginal Delivery(Assessed at delivery.)
- Number of Participants With Readmission Within 30 Days(Assessed from time of discharge until 30 days post-discharge.)
- Patient Satisfaction Six Simple Questions, Q1(At discharge.)
- Patient Satisfaction (Six Simple Questions, Question 2)(At discharge)
- Patient Satisfaction (Six Simple Questions, Question 5)(At discharge)
- Patient Satisfaction (Lady-X Survey, Question 4)(At discharge)
- Patient Satisfaction (Lady-X, Question 7)(At discharge)
- Number of Participants With Neonates With Shoulder Dystocia(Assessed at delivery.)
- Number of Neonates With Umbilical Artery Cord pH < 7.1(Assessed at time of delivery up to 5-minutes post-delivery.)
- Patient Satisfaction (Lady-X Survey, Question 5)(At discharge)
- Patient Satisfaction (Labor Pain Scale, Question 1)(At discharge)
- Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.(From placement until 30 minutes.)
- Number of Participants With Meconium-stained Fluid(Assessed from baseline to delivery.)
- Postpartum Hemorrhage(Assessed at delivery.)
- Patient Satisfaction (Six Simple Questions, Question 3)(At discharge)
- Patient Satisfaction (Six Simple Questions, Question 4)(At discharge)
- Patient Satisfaction (Six Simple Questions, Question 6)(At discharge)
- Patient Satisfaction (Lady-X Survey, Question 1)(At discharge)
- Patient Satisfaction (Labor Pain Scale, Question 3)(At discharge)
- Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12(Assessed at time of delivery up to 5-minutes post-delivery.)
- Patient Satisfaction (Lady-X Survey, Question 2)(At discharge)
- Patient Satisfaction (Lady-X Survey, Question 3)(At discharge)
- Number of Neonates With Birth Injuries(Assessed at time of delivery up to time of neonatal discharge, up to 30 days.)
- Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions(Assessed at time of delivery up to time of neonatal discharge, up to 30-days)
- Patient Satisfaction (Lady-X Survey, Question 6)(At discharge)
- Patient Satisfaction (Labor Pain Scale, Question 2)(At discharge)
- Patient Satisfaction (Labor Pain Scale, Question 4)(At discharge)
研究者
Spencer G. Kuper
Principal Investigator
University of Alabama at Birmingham