Sleep and Depression in Induction of Labour

June 7, 2020 updated by: Kirsi Rinne, Turku University Hospital

Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Outpatient group

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.
Other: Intervention for outpatient group was to go home
Intervention for outpatient group was to go home and assess the the pain
Other Names:
  • Intervention was to assess the pain by visual analogy scale.
Placebo Comparator: Inpatient group

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.
Other: Intervention for inpatient group was to stay at ward
Intervention for inpatient group was to stay at ward and assess the pain
Other Names:
  • Intervention was to assess the pain by visual analogy scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain measured by VAS
Time Frame: one to 14 days after induction of the labor
The pain measured by VAS after double balloon catheter insertion.
one to 14 days after induction of the labor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The affect of the sleep disturbances of the mother to the pain assessed by VAS
Time Frame: one to 14 days after induction of the labor
The affect of the sleep disturbances to the pain assessed by VAS
one to 14 days after induction of the labor
The effect of depression of the mother to the pain assessed by VAS
Time Frame: one to 14 days after induction of the labor
The effect of depression of the mother to the pain assessed by VAS
one to 14 days after induction of the labor
The total hospital stay in both groups
Time Frame: one to 14 days after induction of the labor
The total hospital stay in both groups
one to 14 days after induction of the labor
The maternal and neonatal morbidity after balloon catheter induction
Time Frame: one to 14 days after induction of the labor
The maternal and neonatal morbidity after balloon catheter induction
one to 14 days after induction of the labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

University of Turku

Investigators

  • Principal Investigator: Kirsi M Rinne, PhD, Turku University Hospital
  • Study Director: Päivi ML Polo, PhD, Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T146/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Letter to patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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