Outpatient Foley For Starting Induction of Labor at TErm

Pregnancy Clinical Trial

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Official title:

Outpatient Foley for Starting Induction of Labor at Term

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756689
• Other study ID #: F151022005
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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 information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Inpatient cervical ripening
Subjects will undergo cervical ripening in the inpatient setting.
• Outpatient cervical ripening
Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (16)

ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-97. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation

Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003246. doi: 10.1002/14651858.CD003246.pub2. Review. — View Citation

Dowswell 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. Review. Update in: Cochrane Database Syst Rev. 2017 Sep 13;9:CD007701. — View Citation

Edwards 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):1280-7. doi: 10.1097/AOG.0000000000000238. — View Citation

Farmer 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. — View Citation

Henry 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. — View Citation

Jozwiak 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. Review. — View Citation

Kelly 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. Review. — View Citation

McKenna DS, Costa SW, Samuels P. Prostaglandin E2 cervical ripening without subsequent induction of labor. Obstet Gynecol. 1999 Jul;94(1):11-4. — View Citation

McMaster 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):539-51. doi: 10.1097/AOG.0000000000001002. Review. — View Citation

O'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. — View Citation

Pettker 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. — View Citation

Sciscione 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. — View Citation

Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. — View Citation

WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. — View Citation

Wing DA. Labor induction with misoprostol. Am J Obstet Gynecol. 1999 Aug;181(2):339-45. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Time From Admission to Delivery		From baseline to the time of delivery (baseline is from admission), up to 7 days
Secondary	Total Hospital Duration		From admission time to the hospital until discharge from the hospital, up to 7 days
Secondary	Number of Participants Using Acetaminophen		From placement of Foley bulb to 24 hours.
Secondary	Number of Participants Calling the Obstetrical Triage Unit		From placement of Foley bulb to 24 hours.
Secondary	Number of Participants Admitted Prior to the Scheduled Induction of Labor Time		From placement of Foley bulb to 24 hours.
Secondary	Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission		From placement of Foley bulb to 24 hours.
Secondary	Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.		From placement until 30 minutes.
Secondary	Total Duration of Time of Neuraxial Anesthesia Use		Assessed from baseline to delivery, up to 3 days
Secondary	Total Duration of Time From Rupture of Membranes Until Delivery		Assessed from baseline to delivery, up to 3 days
Secondary	Maximum Oxytocin Rate		Assessed from baseline to delivery, up to 3 days
Secondary	Highest Maternal Intrapartum Temperature		Assessed from baseline to delivery, up to 3 days
Secondary	Number of Participants With Chorioamnionitis		Assessed from baseline to delivery.
Secondary	Number of Participants With Meconium-stained Fluid		Assessed from baseline to delivery.
Secondary	Number of Participants With Neonates With Shoulder Dystocia		Assessed at delivery.
Secondary	Number of Participants Who Had a Cesarean Delivery		Assessed from baseline to delivery.
Secondary	Number of Participants With an Operative Vaginal Delivery		Assessed at delivery.
Secondary	Postpartum Hemorrhage		Assessed at delivery.
Secondary	Number of Participants With Endometritis		Assessed from delivery until 30 days post-discharge.
Secondary	Number of Participants With Readmission Within 30 Days		Assessed from time of discharge until 30 days post-discharge.
Secondary	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.
Secondary	Number of Neonates With Umbilical Artery Cord pH < 7.1		Assessed at time of delivery up to 5-minutes post-delivery.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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