Sleep and Depression in Induction of Labour
Primary Purpose
Prolonged Pregnancy, Sleep Disturbance, Depression
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Intervention for outpatient group was to go home
Intervention for inpatient group was to stay at 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 ≥ 37 - ≤ 41+5
- the patient is living in1/2 hour away from hospital
Exclusion Criteria:
- patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
- the patient has medical treatment of diabetes
- baby is not growing normally
- multiple pregnancy
- preterm rupture of membranes
- earlier caesarean section
- the patient is living more than 1/2 hour away from hospital
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Outpatient group
Inpatient group
Arm Description
After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home. Intervention for outpatient group was to go home.
After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward. Intervention for inpatient group was to stay at ward.
Outcomes
Primary Outcome Measures
The pain measured by VAS
The pain measured by VAS after double balloon catheter insertion.
Secondary Outcome Measures
The affect of the sleep disturbances of the mother to the pain assessed by VAS
The affect of the sleep disturbances to the pain assessed by VAS
The effect of depression of the mother to the pain assessed by VAS
The effect of depression of the mother to the pain assessed by VAS
The total hospital stay in both groups
The total hospital stay in both groups
The maternal and neonatal morbidity after balloon catheter induction
The maternal and neonatal morbidity after balloon catheter induction
Full Information
NCT ID
NCT03380897
First Posted
May 30, 2017
Last Updated
June 7, 2020
Sponsor
Turku University Hospital
Collaborators
University of Turku
1. Study Identification
Unique Protocol Identification Number
NCT03380897
Brief Title
Sleep and Depression in Induction of Labour
Official Title
Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
University of Turku
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.
Detailed Description
Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised 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 investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.
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, Sleep Disturbance, Depression
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
Model Description
Factorial assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient group
Arm Type
Active Comparator
Arm Description
After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home.
Intervention for outpatient group was to go home.
Arm Title
Inpatient group
Arm Type
Placebo Comparator
Arm Description
After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward.
Intervention for inpatient group was to stay at ward.
Intervention Type
Other
Intervention Name(s)
Intervention for outpatient group was to go home
Other Intervention Name(s)
Intervention was to assess the pain by visual analogy scale.
Intervention Description
Intervention for outpatient group was to go home and assess the the pain
Intervention Type
Other
Intervention Name(s)
Intervention for inpatient group was to stay at ward
Other Intervention Name(s)
Intervention was to assess the pain by visual analogy scale.
Intervention Description
Intervention for inpatient group was to stay at ward and assess the pain
Primary Outcome Measure Information:
Title
The pain measured by VAS
Description
The pain measured by VAS after double balloon catheter insertion.
Time Frame
one to 14 days after induction of the labor
Secondary Outcome Measure Information:
Title
The affect of the sleep disturbances of the mother to the pain assessed by VAS
Description
The affect of the sleep disturbances to the pain assessed by VAS
Time Frame
one to 14 days after induction of the labor
Title
The effect of depression of the mother to the pain assessed by VAS
Description
The effect of depression of the mother to the pain assessed by VAS
Time Frame
one to 14 days after induction of the labor
Title
The total hospital stay in both groups
Description
The total hospital stay in both groups
Time Frame
one to 14 days after induction of the labor
Title
The maternal and neonatal morbidity after balloon catheter induction
Description
The maternal and neonatal morbidity after balloon catheter induction
Time Frame
one to 14 days after induction of the labor
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
uncomplicated pregnancy
singleton pregnancy
pregnancy weeks ≥ 37 - ≤ 41+5
the patient is living in1/2 hour away from hospital
Exclusion Criteria:
patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
the patient has medical treatment of diabetes
baby is not growing normally
multiple pregnancy
preterm rupture of membranes
earlier caesarean section
the patient is 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
No
IPD Sharing Plan Description
Letter to patients
Citations:
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
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
result
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
result
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Sleep and Depression in Induction of Labour
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