PregnancyOFFSITENCT02756689
Outpatient Foley For Starting Induction of Labor at TErm
A study testing Inpatient cervical ripening and Outpatient cervical ripening in people with Pregnancy, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Inpatient cervical ripening and Outpatient cervical ripening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- No prior cesarean section or uterine surgery
- Resides within Jefferson County, Alabama.
- Access to a telephone
- Reliable transportation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Inpatient cervical ripening, Outpatient cervical ripening
- Keywords
- Mechanical cervical ripening, Transcervical catheter, Foley catheter for labor induction, Cervical ripening, Induction of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient cervical ripeningOther
Subjects will undergo cervical ripening in the inpatient setting.
Outpatient cervical ripeningOther
Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
| Study group | Role | What they receive |
|---|---|---|
| Inpatient cervical Ripening | Active comparator | 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. Receives: Other: Inpatient cervical ripening |
| Outpatient cervical Ripening | Active comparator | 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. Receives: Other: Outpatient cervical ripening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Time From Admission to Delivery
Measured: From baseline to the time of delivery (baseline is from admission), up to 7 days
Secondary outcomes (40)
Total Hospital Duration
Measured: From admission time to the hospital until discharge from the hospital, up to 7 days
Number of Participants Using Acetaminophen
Measured: From placement of Foley bulb to 24 hours.
Number of Participants Calling the Obstetrical Triage Unit
Measured: From placement of Foley bulb to 24 hours.
Number of Participants Admitted Prior to the Scheduled Induction of Labor Time
Measured: From placement of Foley bulb to 24 hours.
Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission
Measured: From placement of Foley bulb to 24 hours.
Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.
Measured: From placement until 30 minutes.
Total Duration of Time of Neuraxial Anesthesia Use
Measured: Assessed from baseline to delivery, up to 3 days
Total Duration of Time From Rupture of Membranes Until Delivery
Measured: Assessed from baseline to delivery, up to 3 days
Maximum Oxytocin Rate
Measured: Assessed from baseline to delivery, up to 3 days
Highest Maternal Intrapartum Temperature
Measured: Assessed from baseline to delivery, up to 3 days
Number of Participants With Chorioamnionitis
Measured: Assessed from baseline to delivery.
Number of Participants With Meconium-stained Fluid
Measured: Assessed from baseline to delivery.
Number of Participants With Neonates With Shoulder Dystocia
Measured: Assessed at delivery.
Number of Participants Who Had a Cesarean Delivery
Measured: Assessed from baseline to delivery.
Number of Participants With an Operative Vaginal Delivery
Measured: Assessed at delivery.
Postpartum Hemorrhage
Measured: Assessed at delivery.
Number of Participants With Endometritis
Measured: Assessed from delivery until 30 days post-discharge.
Number of Participants With Readmission Within 30 Days
Measured: 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.
Measured: Assessed at time of delivery up to 5-minutes post-delivery.
Number of Neonates With Umbilical Artery Cord pH < 7.1
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spencer G. Kuper, University of Alabama at Birmingham
- Investigators
- Spencer G Kuper, MD, Principal investigator, UAB, Department of Maternal-Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756689
- Sponsor's protocol ID
- F151022005
- Acronym
- OFFSITE
- Status last verified
- Jul 2019
- First submitted
- 11 Apr 2016
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/
PubMed 23586118Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
PubMed 24222365Wing DA. Labor induction with misoprostol. Am J Obstet Gynecol. 1999 Aug;181(2):339-45. doi: 10.1016/s0002-9378(99)70558-2.
PubMed 10454679Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003246. doi: 10.1002/14651858.CD003246.pub2.
PubMed 19821304Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
PubMed 22419277Farmer KC, Schwartz WJ 3rd, Rayburn WF, Turnbull G. A cost-minimization analysis of intracervical prostaglandin E2 for cervical ripening in an outpatient versus inpatient setting. Clin Ther. 1996 Jul-Aug;18(4):747-56; discussion 702. doi: 10.1016/s0149-2918(96)80224-4.
PubMed 8879901Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
PubMed 20687092O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. doi: 10.1016/0002-9378(95)90440-9.
PubMed 8610775McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. doi: 10.1016/s0029-7844(99)00244-6.
PubMed 10389710ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
PubMed 19623003Edwards RK, Szychowski JM, Berger JL, Petersen M, Ingersoll M, Bodea-Braescu AV, Lin MG. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1280-1287. doi: 10.1097/AOG.0000000000000238.
PubMed 24807327Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
PubMed 18515515Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17.
PubMed 24347259Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
PubMed 23356673McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.
PubMed 26244535
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Foley for Starting Induction of Labor at Term
- ClinicalTrials.gov ID
- NCT02756689
- Acronym / sponsor ID
- OFFSITE / F151022005
- Conditions
- Pregnancy
- Keywords
- Mechanical cervical ripening, Transcervical catheter, Foley catheter for labor induction, Cervical ripening, Induction of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient cervical Ripening | Active comparator | Other: Inpatient cervical ripeningSubjects 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 | Active comparator | Other: Outpatient cervical ripeningSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18
- Multiparous
- Singleton gestation
- Gestational age between 39+0 and 42+0
- Vertex presentation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient cervical ripeningSubjects will undergo cervical ripening in the inpatient setting. | Other | Inpatient cervical Ripening |
| Outpatient cervical ripeningSubjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor. | Other | Outpatient cervical Ripening |
Primary outcome
Total Time From Admission to Delivery
Time frame: From baseline to the time of delivery (baseline is from admission), up to 7 days
40 secondary outcomes
Total Hospital Duration
Time frame: From admission time to the hospital until discharge from the hospital, up to 7 days
Number of Participants Using Acetaminophen
Time frame: From placement of Foley bulb to 24 hours.
Number of Participants Calling the Obstetrical Triage Unit
Time frame: From placement of Foley bulb to 24 hours.
Number of Participants Admitted Prior to the Scheduled Induction of Labor Time
Time frame: From placement of Foley bulb to 24 hours.
Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission
Time frame: From placement of Foley bulb to 24 hours.
Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.
Time frame: From placement until 30 minutes.
Total Duration of Time of Neuraxial Anesthesia Use
Time frame: Assessed from baseline to delivery, up to 3 days
Total Duration of Time From Rupture of Membranes Until Delivery
Time frame: Assessed from baseline to delivery, up to 3 days
Maximum Oxytocin Rate
Time frame: Assessed from baseline to delivery, up to 3 days
Highest Maternal Intrapartum Temperature
Time frame: Assessed from baseline to delivery, up to 3 days
Number of Participants With Chorioamnionitis
Time frame: Assessed from baseline to delivery.
Number of Participants With Meconium-stained Fluid
Time frame: Assessed from baseline to delivery.
Number of Participants With Neonates With Shoulder Dystocia
Time frame: Assessed at delivery.
Number of Participants Who Had a Cesarean Delivery
Time frame: Assessed from baseline to delivery.
Number of Participants With an Operative Vaginal Delivery
Time frame: Assessed at delivery.
Postpartum Hemorrhage
Time frame: Assessed at delivery.
Number of Participants With Endometritis
Time frame: Assessed from delivery until 30 days post-discharge.
Number of Participants With Readmission Within 30 Days
Time frame: Assessed from time of discharge until 30 days post-discharge.
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.
Number of Neonates With Umbilical Artery Cord pH < 7.1
Time frame: 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
Time frame: Assessed at time of delivery up to 5-minutes post-delivery.
Number of Neonates With Birth Injuries
Time frame: 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
Time frame: Assessed at time of delivery up to time of neonatal discharge, up to 30-days
Patient Satisfaction Six Simple Questions, Q1
Time frame: At discharge.
Patient Satisfaction (Six Simple Questions, Question 2)
Time frame: At discharge
Patient Satisfaction (Six Simple Questions, Question 3)
Time frame: At discharge
Patient Satisfaction (Six Simple Questions, Question 4)
Time frame: At discharge
Patient Satisfaction (Six Simple Questions, Question 5)
Time frame: At discharge
Patient Satisfaction (Six Simple Questions, Question 6)
Time frame: At discharge
Patient Satisfaction (Lady-X Survey, Question 1)
Time frame: At discharge
Patient Satisfaction (Lady-X Survey, Question 2)
Time frame: At discharge
Patient Satisfaction (Lady-X Survey, Question 3)
Time frame: At discharge
Patient Satisfaction (Lady-X Survey, Question 4)
Time frame: At discharge
Patient Satisfaction (Lady-X Survey, Question 5)
Time frame: At discharge
Patient Satisfaction (Lady-X Survey, Question 6)
Time frame: At discharge
Patient Satisfaction (Lady-X, Question 7)
Time frame: At discharge
Patient Satisfaction (Labor Pain Scale, Question 1)
Time frame: At discharge
Patient Satisfaction (Labor Pain Scale, Question 2)
Time frame: At discharge
Patient Satisfaction (Labor Pain Scale, Question 3)
Time frame: At discharge
Patient Satisfaction (Labor Pain Scale, Question 4)
Time frame: At discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23586118WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/
- Background: PubMed 24222365Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013 Nov 12;(11):CD007372. doi: 10.1002/14651858.CD007372.pub3.
- Background: PubMed 10454679Wing DA. Labor induction with misoprostol. Am J Obstet Gynecol. 1999 Aug;181(2):339-45. doi: 10.1016/s0002-9378(99)70558-2.
- Background: PubMed 19821304Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003246. doi: 10.1002/14651858.CD003246.pub2.
- Background: PubMed 22419277Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Background: PubMed 8879901Farmer KC, Schwartz WJ 3rd, Rayburn WF, Turnbull G. A cost-minimization analysis of intracervical prostaglandin E2 for cervical ripening in an outpatient versus inpatient setting. Clin Ther. 1996 Jul-Aug;18(4):747-56; discussion 702. doi: 10.1016/s0149-2918(96)80224-4.
- Background: PubMed 20687092Dowswell T, Kelly AJ, Livio S, Norman JE, Alfirevic Z. Different methods for the induction of labour in outpatient settings. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007701. doi: 10.1002/14651858.CD007701.pub2.
- Background: PubMed 8610775O'Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 1995 Dec;173(6):1855-9. doi: 10.1016/0002-9378(95)90440-9.
- Background: PubMed 10389710McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. doi: 10.1016/s0029-7844(99)00244-6.
- Background: PubMed 19623003ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
- Background: PubMed 24807327Edwards RK, Szychowski JM, Berger JL, Petersen M, Ingersoll M, Bodea-Braescu AV, Lin MG. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1280-1287. doi: 10.1097/AOG.0000000000000238.
- Background: PubMed 18515515Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spencer G Kuper, MD principal investigator
UAB, Department of Maternal-Fetal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient cervical ripening and Outpatient cervical ripening in people with Pregnancy, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Time From Admission to Delivery (time frame: From baseline to the time of delivery (baseline is from admission), up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756689, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.