The Influence of Antenatal Classes on Pregnancy, Birth an... | NCT00323401

Studies
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood

NCT00323401

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Oct 6, 2021Actual

Enrollment

1,192Actual

Phase

Not Applicable

Conditions

Pregnancy
Parturition

Interventions

Antenatal classes

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2011Actual

First Submitted Date

May 8, 2006

First Submission Date that Met QC Criteria

May 8, 2006

First Posted Date

May 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2021

Last Update Posted Date

Oct 6, 2021Actual

Name	Class
Aarhus University Hospital Skejby	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventon	Experimental	Antenatal classes for the parents	Other: Antenatal classes
Control	No Intervention	No programme are offered

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antenatal classes	Other	3 sessions of 3 hours each	Interventon	1. The delivery process, pain relief and coping strategy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arrival for birth		prospective
Birth experience		prospective
Medical interventions during delivery		prospective
Use of birth analgesia		prospective

Secondary Outcomes

Measure	Description	Time Frame
Length of Birth		prospective
Post partum depression		prospective
Breastfeeding duration and experience

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant Over 18 years of age Singleton

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

52 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jørn Olsen, Professor	University of Aarhus, Department of Epidemiology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Aarhus and University Hospital, Skejby		Aarhus		8000	Denmark
Skejby Sygehus

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24216040	Derived	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.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D064186	Prenatal Education
D000698	Analgesia
D000097813	Coping Skills
D007774	Lactation

ID	Term
D010353	Patient Education as Topic
D006266	Health Education
D011314	Preventive Health Services
D006296	Health Services