Outpatient Foley For Starting Induction of Labor at TErm

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. This is a pilot study to establish the efficacy of this method in decreasing time as in inpatient and evaluate patient satisfaction.

Detailed Description
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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.

Official Title
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Outpatient Foley for Starting Induction of Labor at Term

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Inpatient cervical ripening
* Other: Outpatient cervical ripening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 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 Exclusion Criteria: 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)

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<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. | Other: Inpatient cervical ripening<br>* Subjects will undergo cervical ripening in the inpatient setting.<br>|
| Active Comparator: Outpatient cervical Ripening<br>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. | Other: Outpatient cervical ripening<br>* Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.<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), up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Admitted Prior to the Scheduled Induction of Labor Time |  | 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. | 
| Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement. |  | From placement until 30 minutes. | 
| Total Duration of Time of Neuraxial Anesthesia Use |  | Assessed from baseline to delivery, up to 3 days | 
| Total Duration of Time From Rupture of Membranes Until Delivery |  | 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 With Meconium-stained Fluid |  | Assessed from baseline to delivery. | 
| Number of Participants With Neonates With Shoulder Dystocia |  | Assessed at 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. | 
| Postpartum Hemorrhage |  | Assessed at delivery. | 
| Number of Participants With Endometritis |  | Assessed from delivery until 30 days post-discharge. | 
| Number of Participants With Readmission Within 30 Days |  | Assessed from time of discharge until 30 days post-discharge. | 
| Number of Neonates With a 5-minute Apgar Score Less Than 7 | Apgar scores are assigned to all births. These are universally performed and assigned in the United States. The scoring system is between 0-10. 0 is the minimum score and 10 is the maximum. Lower scores are worse than higher scores. | Assessed at time of delivery up to 5-minutes post-delivery. | 
| Number of Neonates With Umbilical Artery Cord pH < 7.1 |  | Assessed at time of delivery up to 5-minutes post-delivery. | 
| Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12 | Base deficit is a lab value. | Assessed at time of delivery up to 5-minutes post-delivery. | 
| Number of Neonates With Birth Injuries | Cephalohematomas, subgaleal hematomas, fracture of the clavicle, and scalp lacerations | 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 | The rates of neonatal intensive care unit admissions will be calculated. | Assessed at time of delivery up to time of neonatal discharge, up to 30-days | 
| Patient Satisfaction Six Simple Questions, Q1 | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 | At discharge. | 
| Patient Satisfaction (Six Simple Questions, Question 2) | Assessed through validated survey (Six simple questions, Q-2). Question 2: The person(s) responsible for my care are/were caring and compassionate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 | At discharge | 
| Patient Satisfaction (Six Simple Questions, Question 3) | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 3: Problems that have arisen up to now have not been dealt with effectively. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 | At discharge | 
| Patient Satisfaction (Six Simple Questions, Question 4) | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 4: My needs have been addressed with appropriate consideration for my time. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 | At discharge | 
| Patient Satisfaction (Six Simple Questions, Question 5) | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 5: The overall organization of my ca re has not been appropiate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 | At discharge | 
| Patient Satisfaction (Six Simple Questions, Question 6) | Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7. Question 6: I would choose the same type of care for my next pregnancy. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree. Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction. Ranges: 1-7 Best score: 7 Worst score: 1 | At discharge | 
| Patient Satisfaction (Lady-X Survey, Question 1) | Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 1: Presence of healthcare professionals during my birth. Scale 1-3. 1 = At all times, 2 = Most of the time, 3 = rarely Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Lady-X Survey, Question 2) | Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 2: Information given by the healthcare professionals during childbirth. Scale 1-3. 1 = I felt very well informed by the healthcare professionals, 2 = I felt adequately informed by the healthcare professionals, 3 = I felt inadequately informed by the healthcare professionals. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Lady-X Survey, Question 3) | Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 3: Taking your wishes seriously during childbirth. Scale 1-3. 1 = Very seriously, 2 = sufficiently, 3 = insufficiently Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Lady-X Survey, Question 4) | Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 4: Emotional support by healthcare professionals during childbirth. Scale 1-3. 1 = Very well supported, 2 = adequately supported, 3 = inadequately supported. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Lady-X Survey, Question 5) | Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 5: Feeling of security during childbirth: Scale 1-3. 1 = very safe, 2 = sufficiently safe, 3 = insufficiently safe. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Lady-X Survey, Question 6) | Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 6: Worries about the health of your child during childbirth. Scale 1-3; 1 = not worried, 2 = somewhat worried, 3 = very worried. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Lady-X, Question 7) | Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864. Question 7: Time until first contact with your child. Scale 1-3. 1 = Did not take long, 2 = Took quite a long time, 3 = Took a very long time. Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction. Ranges: 1-3 Best score: 1 Worst score: 3 | At discharge | 
| Patient Satisfaction (Labor Pain Scale, Question 1) | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 1: Worst amount of pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0 | At discharge | 
| Patient Satisfaction (Labor Pain Scale, Question 2) | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 2: Overall pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0 | At discharge | 
| Patient Satisfaction (Labor Pain Scale, Question 3) | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 3: Worse amount of pain experienced during the placement of the Foley balloon. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0 | At discharge | 
| Patient Satisfaction (Labor Pain Scale, Question 4) | Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend. Questions 4: How likely are you to recommend your method of induction to a friend or family member. Scale 0-100. 0= very unlikely, 100= very likely. Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction. Ranges: 0-100 Best score: 100 Worst score: 0 | At discharge | 

 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