NCT00323401

Brief Summary

  1. 1.To study the influence of antenatal classes for first time parents and their effect ob pregnancy, birth and parenthood.
  2. 2.Randomized into two groups (a. 3 courses in midpregnancy and b. no courses)
  3. 3.Data on pregnancy, birth and parenthood are collected from register and questionaire

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,192

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 6, 2021

Status Verified

November 1, 2015

Enrollment Period

3.6 years

First QC Date

May 8, 2006

Last Update Submit

September 28, 2021

Conditions

PregnancyParturition

Keywords

PregnancyParturitionDepressionRandomizedAntenatal classes

Outcome Measures

Primary Outcomes (4)

  • Arrival for birth

    prospective

  • Birth experience

    prospective

  • Medical interventions during delivery

    prospective

  • Use of birth analgesia

    prospective

Secondary Outcomes (3)

  • Length of Birth

    prospective

  • Post partum depression

    prospective

  • Breastfeeding duration and experience

    prospective

Study Arms (2)

Interventon

EXPERIMENTAL

Antenatal classes for the parents

Other: Antenatal classes

Control

NO INTERVENTION

No programme are offered

Interventions

Antenatal classesOTHER

3 sessions of 3 hours each

Also known as: 1. The delivery process, pain relief and coping strategy, 2. Infant care and breastfeeding, 3. The parental role and the relationship
Interventon

Eligibility Criteria

Age18 Years - 52 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant Over 18 years of age Singleton

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Aarhus and University Hospital, Skejby

Aarhus, 8000, Denmark

Location

Skejby Sygehus

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Maimburg RD, Vaeth M, Hvidman L, Durr J, Olsen J. Women's worries in first pregnancy: results from a randomised controlled trial. Sex Reprod Healthc. 2013 Dec;4(4):129-31. doi: 10.1016/j.srhc.2013.10.001. Epub 2013 Oct 9.

    PMID: 24216040DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

Prenatal EducationAnalgesiaCoping SkillsLactation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesAnesthesia and AnalgesiaBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Jørn Olsen, Professor

    University of Aarhus, Department of Epidemiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 9, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2011

Last Updated

October 6, 2021

Record last verified: 2015-11

Locations

DK(2)