Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women

Study Overview
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Brief Summary
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The investigators are performing a randomized controlled trial investigating starting cervical ripening in the outpatient setting with a mechanical method, the transcervical Foley catheter. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

Detailed Description
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Approximately 20-25% of pregnant women undergo an induction of labor, and a large percentage of these women require cervical ripening in order to ready the cervix for induction. In the setting of an unfavorable cervix, induction of labor with oxytocin alone can be associated with longer times to delivery, uterine tachysystole (uterine contractions that are too frequent), and increased rates of cesarean delivery. Outpatient cervical ripening is an attractive option for both women and their physicians, as this allows for the potential to spend less time in the hospital and more time in the comforts of the patient's own 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 from the hospital.

Official Title
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Outpatient Foley For Starting Induction of Labor at Term in Nulliparous Women: A Randomized-Controlled Study

Conditions
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Pregnancy Related

Intervention / Treatment
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* Procedure: Transcervical Foley catheter placement for cervical ripening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Nulliparous Singleton gestation Gestational age between 39+0 and 42+0 weeks Vertex presentation Modified Bishop score <5 and cervical dilation ≤ 2 cm No prior cesarean or prior uterine surgery Resides within 30 minutes of UAB Hospital Access to a telephone Reliable transportation Exclusion Criteria: Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible. Latex allergy Contraindication to induction of labor Evidence of labor Fetal demise Fetal anomaly Inability to give consent (e.g., inability to read or write)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inpatient cervical ripening group<br>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. | Procedure: Transcervical Foley catheter placement for cervical ripening<br>* Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.<br>|
| Active Comparator: Outpatient cervical ripening group<br>Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (intervention arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next day to be admitted to labor and delivery for induction of labor with oxytocin. | Procedure: Transcervical Foley catheter placement for cervical ripening<br>* Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time from admission to delivery |  | From baseline to the time of delivery (baseline is from admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Bishop score on admission |  | At baseline | 
| Evaluation of patient satisfaction with care | Assessed through survey adapted from Six Simple Questions Survey, which has been published by Harvey et al (Harvey et al. Evaluation of satisfaction with midwifery care. Midwifery. 2002 Dec; 18(4):260-7.) This survey has 6 questions to assess perceptions of satisfaction with care. The questions include questions such as, I had appropriate and adequate control over my care, The person(s) responsible for my care are/were caring and compassionate, and Problems that have arisen up to now have not been dealt with effectively. The scare ranges from 1-7, with 1 representing Strongly Disagree and 7 representing Strongly Agree. | Within 2-4 days after delivery | 
| Evaluation of patient experience on labor and delivery | Assessed through survey adapted from Labor and Delivery Index (LADY-X Survey, which has been published by Gartner et al (Gartner et al. Calculating Preference Weights for the Labor and Delivery Index: A Discrete Choice Experiment on Women's Birth Experiences. Value Health. 2015 Sep; 18(6):856-864.) This survey has 7 questions to assess experiences during labor and birth. Each question then has 3 answer choices that describe how good/poor the experience was. An example of a question is, Taking your wishes seriously during childbirth. The answers then include very seriously, sufficiently seriously, or insufficiently seriously. | Within 2-4 days after delivery | 
| Evaluation of pain experienced during childbirth | Assessed through survey that contains 4 questions. The first 3 questions assess pain (worst pain during labor, overall pain during labor, and worse pain during placement of the Foley balloon). The 4th question asks how likely a patient is to recommend her method of induction to a friend/family member. The scale ranges from 0-100, with 0 representing no pain or very unlikely and 100 representing pain as bad as it could possibly be or very likely. The patient is instructed to place a hash mark over the line. | From placement of Foley bulb to delivery | 
| Vaginal bleeding greater than bloody show | Vaginal bleeding that is like a period or more | From placement of Foley bulb to delivery | 
| Total hospital duration |  | From hospital admission to hospital discharge (generally less than one week) | 
| Rates of acetaminophen use |  | From placement of Foley bulb to 24 hours | 
| Rates of calls to the obstetrical triage unit |  | From placement of Foley bulb to 24 hours | 
| Early admission or early visit to the obstetrical triage unit prior to scheduled induction of labor time |  | From placement of Foley bulb to 24 hours | 
| Rates of spontaneous rupture of membranes between Foley bulb placement and admission |  | From placement of Foley bulb to 24 hours | 
| Non-reassuring fetal heart rate tracings 30-minutes after Foley bulb placement |  | From placement of Foley bulb to 30 minutes | 
| Total duration of time of neuraxial anesthesia use |  | From baseline to delivery | 
| Total time of oxytocin infusion |  | From baseline to delivery | 
| Maximum oxytocin rate |  | From baseline to delivery | 
| Highest maternal intrapartum temperature |  | From baseline to delivery | 
| Rates of chorioamnionitis |  | From baseline to delivery | 
| Rates of endometritis |  | From delivery until 30 days post-discharge | 
| Mode of delivery | Rates of vaginal delivery, cesarean delivery, and operative vaginal delivery (vacuum or forceps) | From baseline to delivery | 
| Postpartum hemorrhage |  | At delivery | 
| Rates of hospital readmission within 30 days |  | From hospital discharge until 30 days post-discharge | 
| Rates of 5-minute Apgar score <7 |  | From time of delivery up to 5 minutes post-delivery | 
| Rates of umbilical cord artery pH <7.1 |  | From time of delivery up to 5 minutes post-delivery | 
| Rates of umbilical cord artery base deficit <-12 |  | From time of delivery up to 5 minutes post-delivery | 
| Rates of neonatal intensive care unit admissions |  | After delivery and before neonatal discharge (generally less than one week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical cervical ripening, Transcervical catheter, Foley catheter for labor induction, Cervical ripening, Induction of labor