PregnancyNCT00323401
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood
A study testing Antenatal classes in people with Pregnancy and Parturition, run by University of Aarhus at 2 sites in Denmark.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Pregnancy, Parturition
- What is being tested?
- Antenatal classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,192 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant Over 18 years of age Singleton
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University of Aarhus and University Hospital, Skejby
Aarhus, 8000
Skejby Sygehus
Aarhus, 8200
About this study
- 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
Read the detailed description
Data collected contain register data and data from questionnaire, which also contains psychometric tests
- Conditions
- Pregnancy, Parturition
- Being tested
- Antenatal classes
- Keywords
- Pregnancy, Parturition, Depression, Randomized, Antenatal classes
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal classesOther
Also called 1. The delivery process, pain relief and coping strategy, 2. Infant care and breastfeeding, 3. The parental role and the relationship
3 sessions of 3 hours each
| Study group | Role | What they receive |
|---|---|---|
| Interventon | Experimental | Antenatal classes for the parents Receives: Other: Antenatal classes |
| Control | No intervention | No programme are offered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrival for birth
Measured: prospective
Birth experience
Measured: prospective
Medical interventions during delivery
Measured: prospective
Use of birth analgesia
Measured: prospective
Secondary outcomes (3)
Length of Birth
Measured: prospective
Post partum depression
Measured: prospective
Breastfeeding duration and experience
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Responsible party
- Sponsor
- Investigators
- Jørn Olsen, Professor, Study chair, University of Aarhus, Department of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323401
- Sponsor's protocol ID
- RDM2006
- Status last verified
- Nov 2015
- First submitted
- 8 May 2006
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24216040
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood
- ClinicalTrials.gov ID
- NCT00323401
- Acronym / sponsor ID
- RDM2006
- Conditions
- Pregnancy, Parturition
- Keywords
- Pregnancy, Parturition, Depression, Randomized, Antenatal classes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,192 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Study start
- May 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventon | Experimental | Other: Antenatal classesAntenatal classes for the parents |
| Control | No intervention | –No programme are offered |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant Over 18 years of age Singleton
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal classesAlso: 1. The delivery process, pain relief and coping strategy, 2. Infant care and breastfeeding, 3. The parental role and the relationship3 sessions of 3 hours each | Other | Interventon |
Primary outcome
Arrival for birth
Time frame: prospective
Birth experience
Time frame: prospective
Medical interventions during delivery
Time frame: prospective
Use of birth analgesia
Time frame: prospective
3 secondary outcomes
Length of Birth
Time frame: prospective
Post partum depression
Time frame: prospective
Breastfeeding duration and experience
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Derived from this study: PubMed 24216040Maimburg 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.
- Published resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørn Olsen, Professor study chair
University of Aarhus, Department of Epidemiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal classes in people with Pregnancy and Parturition, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrival for birth (time frame: prospective). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00323401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.