NCT02793609

Brief Summary

Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

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

June 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3.6 years

First QC Date

June 3, 2016

Last Update Submit

June 5, 2020

Conditions

Prolonged Pregnancy

Keywords

induction of labordouble balloon cathetermechanical ripening

Outcome Measures

Primary Outcomes (1)

  • The pain measured by visual analogy scale(VAS) after double balloon catheter

    Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.

    During the induction of the labor and postpartum period in the hospital.

Secondary Outcomes (3)

  • The maternal morbidity

    during the induction of the labor and postpartum period in the hospital

  • The total hospital stay in both groups

    maximum 14 days

  • neonatal morbidity

    during the induction of the labor and postpartum period in the hospital

Study Arms (2)

Outpatient group

OTHER

After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.

Other: Intervention is to let patient to go home.

Inpatient group

OTHER

After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.

Other: Intervention is to observe women in the ward.

Interventions

Intervention is to let patient to go home.OTHER

Intervention is to let patient to go home.

Outpatient group
Intervention is to observe women in the ward.OTHER

Intervention is to observe women in the ward.

Inpatient group

Eligibility Criteria

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

You may qualify if:

  • uncomplicated pregnancy
  • singleton pregnancy
  • pregnancy weeks between \>37 and \<41+5
  • the patient is living in 1/2 hour away from hospital

You may not qualify if:

  • patient has any disease or medication
  • multiple pregnancy
  • pregnancy week \> 41+5
  • preterm rupture of membranes
  • patient living more than 1/2 hour away from hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (4)

  • 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

  • Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.

    PMID: 18715244BACKGROUND

  • 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: 23356673RESULT

  • 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

MeSH Terms

Conditions

Pregnancy, Prolonged

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kirsi M Rinne, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

  • Päivi ML Polo, PhD

    Turku University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 8, 2016

Study Start

June 1, 2016

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

FI(1)