Condition category
Pregnancy and Childbirth
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr K.M. Pal, van der-de Bruin

ORCID ID

Contact details

TNO Quality of Life
P.O. Box 2215
Leiden
2301 CE
Netherlands
+31 (0)71 5181836
KM.vanderPal@pg.tno.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw Project number 22000044 and 2200.0135; NTR456

Study information

Scientific title

GP-initiated preconception counselling

Acronym

Parents to Be

Study hypothesis

At least 20% of the pregnancies in the Netherlands end in an adverse pregnancy outcome (spontaneous abortion, preterm birth, low birth weight, perinatal death, congenital anomaly). Information on risk factors before pregnancy together with preventive measures (preconception counselling) will lead to behavioural changes and thus to reduced adverse pregnancy outcomes.

Ethics approval

Ethics approval received from the Medical Ethics Committee of Leiden University Medical Centre.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Adverse pregnancy outcome

Intervention

In the intervention group women 18 - 40 years received an invitation for preconception counselling. When interested and contemplating a pregnancy within a year a risk-assessment questionnaire was used to systematically assess risks of the couple. Counselling was provided based on risks identified as well as risks which apply to all women.

The control group received care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The effect of GP-initiated preconception counselling (PCC) on adverse pregnancy outcome (spontaneous abortion, preterm birth, low birth weight, perinatal death, congenital anomaly).

Secondary outcome measures

1. Evaluation of women’s knowledge of risk factors for the foetus and the influence of PCC on this knowledge
2. Prevalence of risk factors
3. Response to invitation of PCC
4. Anxiety induction by invitation or counselling
5. Satisfaction with counselling
6. Influence of PCC on risk-reducing behavior
7. GP satisfaction with the systematic PCC program and barriers for implication

Overall trial start date

09/01/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 18 - 40 years.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

4800

Participant exclusion criteria

1. Completed family
2. Uterus extirpation
3. Sub-fertility or infertility
4. Insufficient understanding of Dutch
5. Adverse social circumstances

Recruitment start date

09/01/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

TNO Quality of Life
Leiden
2301 CE
Netherlands

Sponsor information

Organisation

TNO Quality of Life, Division of Child Health, Prevention and Physical Activity (The Netherlands)

Sponsor details

P.O. Box 2215
Leiden
2301 CE
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/16824233
2. http://www.ncbi.nlm.nih.gov/pubmed/17083722

Publication citations

  1. Elsinga J, van der Pal-de Bruin K, le Cessie S, de Jong-Potjer L, Verloove-Vanhorick S, Assendelft W, Preconception counselling initiated by general practitioners in the Netherlands: reaching couples contemplating pregnancy [ISRCTN53942912]., BMC Fam Pract, 2006, 7, 41, doi: 10.1186/1471-2296-7-41.

  2. de Jong-Potjer LC, Elsinga J, le Cessie S, van der Pal-de Bruin KM, Neven AK, Buitendijk SE, Assendelft WJ, GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety., BMC Fam Pract, 2006, 7, 66, doi: 10.1186/1471-2296-7-66.

Additional files

Editorial Notes