Back to resultsOutpatient Versus Inpatient Balloon Catheter Induction of Labor
Primary Purpose
Prolonged Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intervention is to let patient to go home.
Intervention is to observe women in the ward.
Sponsored by
About this trial
This is an interventional health services research trial for Prolonged Pregnancy focused on measuring induction of labor, double balloon catheter, mechanical ripening
Eligibility Criteria
Inclusion Criteria:
- uncomplicated pregnancy
- singleton pregnancy
- pregnancy weeks between >37 and <41+5
- the patient is living in 1/2 hour away from hospital
Exclusion Criteria:
- 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
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Outpatient group
Inpatient group
Arm Description
After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.
After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.
Outcomes
Primary Outcome Measures
The pain measured by visual analogy scale(VAS) after double balloon catheter
Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.
Secondary Outcome Measures
The maternal morbidity
number of mothers having any kind of infection
The total hospital stay in both groups
length in days
neonatal morbidity
number of babies having any kind of infection
Full Information
NCT ID
NCT02793609
First Posted
June 3, 2016
Last Updated
June 5, 2020
Sponsor
Turku University Hospital
Collaborators
University of Turku
1. Study Identification
Unique Protocol Identification Number
NCT02793609
Brief Title
Outpatient Versus Inpatient Balloon Catheter Induction of Labor
Official Title
Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.
The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Pregnancy
Keywords
induction of labor, double balloon catheter, mechanical ripening
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient group
Arm Type
Other
Arm Description
After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home.
Arm Title
Inpatient group
Arm Type
Other
Arm Description
After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward.
Intervention Type
Other
Intervention Name(s)
Intervention is to let patient to go home.
Intervention Description
Intervention is to let patient to go home.
Intervention Type
Other
Intervention Name(s)
Intervention is to observe women in the ward.
Intervention Description
Intervention is to observe women in the ward.
Primary Outcome Measure Information:
Title
The pain measured by visual analogy scale(VAS) after double balloon catheter
Description
Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.
Time Frame
During the induction of the labor and postpartum period in the hospital.
Secondary Outcome Measure Information:
Title
The maternal morbidity
Description
number of mothers having any kind of infection
Time Frame
during the induction of the labor and postpartum period in the hospital
Title
The total hospital stay in both groups
Description
length in days
Time Frame
maximum 14 days
Title
neonatal morbidity
Description
number of babies having any kind of infection
Time Frame
during the induction of the labor and postpartum period in the hospital
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
uncomplicated pregnancy
singleton pregnancy
pregnancy weeks between >37 and <41+5
the patient is living in 1/2 hour away from hospital
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsi M Rinne, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Päivi ML Polo, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Letter to patients.
Citations:
PubMed Identifier
11704164
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. doi: 10.1016/s0029-7844(01)01579-4.
Results Reference
background
PubMed Identifier
18715244
Citation
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.
Results Reference
background
PubMed Identifier
23356673
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.
Results Reference
result
PubMed Identifier
32852803
Citation
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.
Results Reference
derived
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Outpatient Versus Inpatient Balloon Catheter Induction of Labor
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