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Outpatient Versus Inpatient Balloon Catheter Induction of Labor

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ClinicalTrials.gov Identifier: NCT02793609
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
University of Turku
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prolonged Pregnancy Other: Intervention is to let patient to go home. Other: Intervention is to observe women in the ward. Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Outpatient group
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.
Intervention is to let patient to go home.
Inpatient group
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.
Intervention is to observe women in the ward.


Outcome Measures
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Primary Outcome Measures :
  1. The pain measured by visual analogy scale(VAS) after double balloon catheter [ Time Frame: During the induction of the labor and postpartum period in the hospital. ]
    Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.


Secondary Outcome Measures :
  1. The maternal morbidity [ Time Frame: during the induction of the labor and postpartum period in the hospital ]
    number of mothers having any kind of infection

  2. The total hospital stay in both groups [ Time Frame: maximum 14 days ]
    length in days

  3. neonatal morbidity [ Time Frame: during the induction of the labor and postpartum period in the hospital ]
    number of babies having any kind of infection


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793609


Locations
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Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
University of Turku
Investigators
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Principal Investigator: Kirsi M Rinne, PhD Turku University Hospital
Study Director: Päivi ML Polo, PhD Turku University Hospital
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02793609    
Other Study ID Numbers: T169/2016
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Letter to patients.
Keywords provided by Turku University Hospital:
induction of labor
double balloon catheter
mechanical ripening
Additional relevant MeSH terms:
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Pregnancy, Prolonged
Pregnancy Complications