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Completed

NCT Number: NCT02756689

Outpatient Foley For Starting Induction of Labor at TErm

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Inpatient cervical ripening

Other

Subjects will undergo cervical ripening in the inpatient setting.

Outpatient cervical ripening

Other

Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.

Primary outcomes

  1. Total Time From Admission to Delivery

    Time frame: From baseline to the time of delivery (baseline is from admission), up to 7 days

Secondary outcomes

  1. Total Hospital Duration

    Time frame: From admission time to the hospital until discharge from the hospital, up to 7 days

  2. Number of Participants Using Acetaminophen

    Time frame: From placement of Foley bulb to 24 hours.

  3. Number of Participants Calling the Obstetrical Triage Unit

    Time frame: From placement of Foley bulb to 24 hours.

  4. Number of Participants Admitted Prior to the Scheduled Induction of Labor Time

    Time frame: From placement of Foley bulb to 24 hours.

  5. Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission

    Time frame: From placement of Foley bulb to 24 hours.

  6. Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.

    Time frame: From placement until 30 minutes.

  7. Total Duration of Time of Neuraxial Anesthesia Use

    Time frame: Assessed from baseline to delivery, up to 3 days

  8. Total Duration of Time From Rupture of Membranes Until Delivery

    Time frame: Assessed from baseline to delivery, up to 3 days

  9. Maximum Oxytocin Rate

    Time frame: Assessed from baseline to delivery, up to 3 days

  10. Highest Maternal Intrapartum Temperature

    Time frame: Assessed from baseline to delivery, up to 3 days

  11. Number of Participants With Chorioamnionitis

    Time frame: Assessed from baseline to delivery.

  12. Number of Participants With Meconium-stained Fluid

    Time frame: Assessed from baseline to delivery.

  13. Number of Participants With Neonates With Shoulder Dystocia

    Time frame: Assessed at delivery.

  14. Number of Participants Who Had a Cesarean Delivery

    Time frame: Assessed from baseline to delivery.

  15. Number of Participants With an Operative Vaginal Delivery

    Time frame: Assessed at delivery.

  16. Postpartum Hemorrhage

    Time frame: Assessed at delivery.

  17. Number of Participants With Endometritis

    Time frame: Assessed from delivery until 30 days post-discharge.

  18. Number of Participants With Readmission Within 30 Days

    Time frame: Assessed from time of discharge until 30 days post-discharge.

  19. Number of Neonates With a 5-minute Apgar Score Less Than 7

    Time frame: 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.

  20. Number of Neonates With Umbilical Artery Cord pH < 7.1

    Time frame: Assessed at time of delivery up to 5-minutes post-delivery.

  21. Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12

    Time frame: Assessed at time of delivery up to 5-minutes post-delivery.

    Base deficit is a lab value.

  22. Number of Neonates With Birth Injuries

    Time frame: 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

  23. Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions

    Time frame: 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.

  24. Patient Satisfaction Six Simple Questions, Q1

    Time frame: 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: 1

  25. Patient Satisfaction (Six Simple Questions, Question 2)

    Time frame: 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: 1

  26. Patient Satisfaction (Six Simple Questions, Question 3)

    Time frame: 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: 1

  27. Patient Satisfaction (Six Simple Questions, Question 4)

    Time frame: 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: 1

  28. Patient Satisfaction (Six Simple Questions, Question 5)

    Time frame: 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: 1

  29. Patient Satisfaction (Six Simple Questions, Question 6)

    Time frame: 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: 1

  30. Patient Satisfaction (Lady-X Survey, Question 1)

    Time frame: 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: 3

  31. Patient Satisfaction (Lady-X Survey, Question 2)

    Time frame: 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: 3

  32. Patient Satisfaction (Lady-X Survey, Question 3)

    Time frame: 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: 3

  33. Patient Satisfaction (Lady-X Survey, Question 4)

    Time frame: 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: 3

  34. Patient Satisfaction (Lady-X Survey, Question 5)

    Time frame: 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: 3

  35. Patient Satisfaction (Lady-X Survey, Question 6)

    Time frame: 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: 3

  36. Patient Satisfaction (Lady-X, Question 7)

    Time frame: 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: 3

  37. Patient Satisfaction (Labor Pain Scale, Question 1)

    Time frame: 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: 0

  38. Patient Satisfaction (Labor Pain Scale, Question 2)

    Time frame: 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: 0

  39. Patient Satisfaction (Labor Pain Scale, Question 3)

    Time frame: 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: 0

  40. Patient Satisfaction (Labor Pain Scale, Question 4)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: OFFSITE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2016
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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