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 womens 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
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
-
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.
-
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.