Outpatient Foley For Starting Induction of Labor at TErm
- Conditions
- Pregnancy
- Interventions
- Other: Inpatient cervical ripeningOther: Outpatient cervical ripening
- Registration Number
- NCT02756689
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inpatient cervical Ripening 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. Outpatient cervical Ripening 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.
- Primary Outcome Measures
Name Time Method Total Time From Admission to Delivery From baseline to the time of delivery (baseline is from admission), up to 7 days
- Secondary Outcome Measures
Name Time Method 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. 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.
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. 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: 1Patient Satisfaction (Six Simple Questions, Question 2) At discharge 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: 1Patient Satisfaction (Six Simple Questions, Question 5) At discharge 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: 1Patient Satisfaction (Lady-X Survey, Question 4) At discharge 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: 3Patient Satisfaction (Lady-X, Question 7) At discharge 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: 3Number 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 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: 3Patient Satisfaction (Labor Pain Scale, Question 1) At discharge 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: 0Nonreassuring 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 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: 1Patient Satisfaction (Six Simple Questions, Question 4) At discharge 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: 1Patient Satisfaction (Six Simple Questions, Question 6) At discharge 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: 1Patient Satisfaction (Lady-X Survey, Question 1) At discharge 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: 3Patient Satisfaction (Labor Pain Scale, Question 3) At discharge 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: 0Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12 Assessed at time of delivery up to 5-minutes post-delivery. Base deficit is a lab value.
Patient Satisfaction (Lady-X Survey, Question 2) At discharge 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: 3Patient Satisfaction (Lady-X Survey, Question 3) At discharge 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: 3Number of Neonates With Birth Injuries Assessed at time of delivery up to time of neonatal discharge, up to 30 days. Cephalohematomas, subgaleal hematomas, fracture of the clavicle, and scalp lacerations
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 The rates of neonatal intensive care unit admissions will be calculated.
Patient Satisfaction (Lady-X Survey, Question 6) At discharge 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: 3Patient Satisfaction (Labor Pain Scale, Question 2) At discharge 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: 0Patient Satisfaction (Labor Pain Scale, Question 4) At discharge 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
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States