NCT03472937

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. The objective of the study is to determine if outpatient compared to inpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing induction shortens the time spent in labor and delivery (from the time of admission to the time of delivery).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

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

First Submitted

Initial submission to the registry

February 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

February 12, 2018

Last Update Submit

February 4, 2020

Conditions

Pregnancy Related

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)

Secondary Outcomes (24)

  • Modified Bishop score on admission

    At baseline

  • Evaluation of patient satisfaction with care

    Within 2-4 days after delivery

  • Evaluation of patient experience on labor and delivery

    Within 2-4 days after delivery

  • Evaluation of pain experienced during childbirth

    From placement of Foley bulb to delivery

  • Vaginal bleeding greater than bloody show

    From placement of Foley bulb to delivery

  • +19 more secondary outcomes

Study Arms (2)

Inpatient cervical ripening group

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.

Procedure: Transcervical Foley catheter placement for cervical ripening

Outpatient cervical ripening group

ACTIVE COMPARATOR

Subjects in this arm will undergo cervical ripening with a transcervical Foley catheter in the outpatient setting (intervention arm). The transcervical catheter will be placed in the office after confirmation of fetal well-being. They will then return the next day to be admitted to labor and delivery for induction of labor with oxytocin.

Procedure: Transcervical Foley catheter placement for cervical ripening

Interventions

Transcervical Foley catheter placement for cervical ripeningPROCEDURE

Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.

Inpatient cervical ripening groupOutpatient cervical ripening group

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • Nulliparous
  • Singleton gestation
  • Gestational age between 39+0 and 42+0 weeks
  • Vertex presentation
  • Modified Bishop score \<5 and cervical dilation ≤ 2 cm
  • No prior cesarean or prior uterine surgery
  • Resides within 30 minutes of UAB Hospital
  • Access to a telephone
  • Reliable transportation

You may not qualify if:

  • Unsuitable for outpatient cervical ripening (e.g., IUGR, oligohydramnios, polyhydramnios, gestational hypertension or preeclampsia, complex maternal disease, provider discretion). Patients with well controlled Class A or B DM or chronic hypertension will be eligible.
  • Latex allergy
  • Contraindication to induction of labor
  • Evidence of labor
  • Fetal demise
  • Fetal anomaly
  • Inability to give consent (e.g., inability to read or write)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (16)

  • 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

  • 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

  • Amorosa JM, Stone JL. Outpatient cervical ripening. Semin Perinatol. 2015 Oct;39(6):488-94. doi: 10.1053/j.semperi.2015.07.014. Epub 2015 Sep 11.

    PMID: 26365009BACKGROUND

  • 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

  • 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: 11704164BACKGROUND

  • 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

  • Rayburn W, Gosen R, Ramadei C, Woods R, Scott J Jr. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1417-23. doi: 10.1016/0002-9378(88)90376-6.

    PMID: 3289398BACKGROUND

  • Sawai SK, O'Brien WF, Mastrogiannis DS, Krammer J, Mastry MG, Porter GW. Patient-administered outpatient intravaginal prostaglandin E2 suppositories in post-date pregnancies: a double-blind, randomized, placebo-controlled study. Obstet Gynecol. 1994 Nov;84(5):807-10.

    PMID: 7936516BACKGROUND

  • Biem SR, Turnell RW, Olatunbosun O, Tauh M, Biem HJ. A randomized controlled trial of outpatient versus inpatient labour induction with vaginal controlled-release prostaglandin-E2: effectiveness and satisfaction. J Obstet Gynaecol Can. 2003 Jan;25(1):23-31. doi: 10.1016/s1701-2163(16)31079-9.

    PMID: 12548322BACKGROUND

  • Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.

    PMID: 24824157BACKGROUND

  • 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

  • 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

  • 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

  • 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

  • Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, Casey BM, Szychowski JM, Harper LM, Tita AT. Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):597-606. doi: 10.1097/AOG.0000000000004041.

    PMID: 32769658DERIVED

Related Links

MeSH Terms

Interventions

Cervical Ripening

Intervention Hierarchy (Ancestors)

Labor, ObstetricPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Elizabeth B Ausbeck, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

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
Fellow, Maternal-Fetal Medicine

Study Record Dates

First Submitted

February 12, 2018

First Posted

March 21, 2018

Study Start

May 4, 2018

Primary Completion

November 1, 2019

Study Completion

December 13, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)