NCT02756689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 9, 2019

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

April 11, 2016

Results QC Date

October 3, 2018

Last Update Submit

July 3, 2019

Conditions

Pregnancy

Keywords

Mechanical cervical ripeningTranscervical catheterFoley catheter for labor inductionCervical ripeningInduction of labor

Outcome Measures

Primary Outcomes (1)

  • Total Time From Admission to Delivery

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

Secondary Outcomes (40)

  • Total Hospital Duration

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

  • Number of Participants Using Acetaminophen

    From placement of Foley bulb to 24 hours.

  • Number of Participants Calling the Obstetrical Triage Unit

    From placement of Foley bulb to 24 hours.

  • Number of Participants Admitted Prior to the Scheduled Induction of Labor Time

    From placement of Foley bulb to 24 hours.

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

    From placement of Foley bulb to 24 hours.

  • +35 more secondary outcomes

Study Arms (2)

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.

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.

Other: Outpatient cervical ripening

Interventions

Inpatient cervical ripeningOTHER

Subjects will undergo cervical ripening in the inpatient setting.

Inpatient cervical Ripening
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.

Outpatient cervical Ripening

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (18)

  • WHO Recommendations for Induction of Labour. Geneva: World Health Organization; 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK131963/

    PMID: 23586118BACKGROUND

  • 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.

    PMID: 24222365BACKGROUND

  • Wing DA. Labor induction with misoprostol. Am J Obstet Gynecol. 1999 Aug;181(2):339-45. doi: 10.1016/s0002-9378(99)70558-2.

    PMID: 10454679BACKGROUND

  • Alfirevic 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.

    PMID: 19821304BACKGROUND

  • 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.

    PMID: 22419277BACKGROUND

  • 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. doi: 10.1016/s0149-2918(96)80224-4.

    PMID: 8879901BACKGROUND

  • 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.

    PMID: 20687092BACKGROUND

  • 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. doi: 10.1016/0002-9378(95)90440-9.

    PMID: 8610775BACKGROUND

  • McKenna 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.

    PMID: 10389710BACKGROUND

  • ACOG 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.

    PMID: 19623003BACKGROUND

  • 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):1280-1287. doi: 10.1097/AOG.0000000000000238.

    PMID: 24807327BACKGROUND

  • 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.

    PMID: 18515515BACKGROUND

  • 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.

    PMID: 24347259BACKGROUND

  • 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.

    PMID: 23356673BACKGROUND

  • 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):539-551. doi: 10.1097/AOG.0000000000001002.

    PMID: 26244535BACKGROUND

  • 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. doi: 10.1016/s0029-7844(01)01579-4.

    PMID: 11704164RESULT

  • Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

    PMID: 32852803DERIVED

  • Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.

    PMID: 29889751DERIVED

Limitations and Caveats

Results may not be generalizable to all women, safety cannot be inferred as the incidence of adverse outcomes was low.

Results Point of Contact

Title
Lorie Harper, MD
Organization
UAB
lmharper@uabmc.edu
205-934-5611

Study Officials

  • Spencer G Kuper, MD

    UAB, Department of Maternal-Fetal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 29, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 9, 2019

Results First Posted

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)