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The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Skejby Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00323401
First received: May 8, 2006
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose
  1. To study the influence of antenatal classes for first time parents and their effect ob pregnancy, birth and parenthood.
  2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)
  3. Data on pregnancy, birth and parenthood are collected from register and questionaire

Condition Intervention Phase
Pregnancy
Parturition
 Other: Antenatal classes
Other: Educational programme
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Arrival for birth [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
  • Birth experience [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
  • Medical interventions during delivery [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
  • Use of birth analgesia [ Time Frame: prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of Birth [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
  • Post partum depression [ Time Frame: prospective ] [ Designated as safety issue: Yes ]
  • Breastfeeding duration and experience [ Time Frame: prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: May 2006
Estimated Study Completion Date: December 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventon
Antenatal classes for the parents
 Other: Antenatal classes
3 sessions of 3 hours each
Other Names:
  • 1. The delivery process, pain relief and coping strategy
  • 2. Infant care and breastfeeding
  • 3. The parental role and the relationship
Other: Educational programme
3 times, 3 hours intervention programme
Other Name: Birth preparations courses
No Intervention: Control
No programme are offered
 Other: Antenatal classes
antenatal programme
Other Name: Birth preparations courses
Other: Educational programme
no programme are offered
Other Name: Birth preparations courses

Detailed Description:

Data collected contain register data and data from questionnaire, which also contains psychometric tests

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Pregnant Over 18 years of age Singleton

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323401

Locations
Denmark
University of Aarhus and University Hospital, Skejby
Aarhus, Denmark, 8000
Skejby Sygehus
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Skejby Hospital
Investigators
Study Chair: Jørn Olsen, Professor University of Aarhus, Department of Epidemiology
  More Information

Additional Information:
Homepage for the project  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00323401     History of Changes
Other Study ID Numbers: RDM2006
Study First Received: May 8, 2006
Last Updated: November 4, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Pregnancy
Parturition
Depression
Randomized
Antenatal classes

ClinicalTrials.gov processed this record on June 18, 2013