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'Parents to be' The effectiveness of systematic population-based preconception advice and counselling initiated by GP's.


- candidate number1764
- NTR NumberNTR456
- ISRCTNISRCTN53942912
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR14-okt-2005
- Secondary IDsZON-MW Project number 22000044 and 2200.0135 
- Public Title'Parents to be' The effectiveness of systematic population-based preconception advice and counselling initiated by GP's.
- Scientific TitleGP-initiated preconception counseling.
- ACRONYMParents to Be
- hypothesisAt 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 (preconcpetion counseling) will lead to behavioural changes and thus to reduced adverse pregnancy outcomes.
- Healt Condition(s) or Problem(s) studiedPregnancy outcome
- Inclusion criteriaWomen aged 18-40.
- Exclusion criteriaCompleted family, uterus extirpation, sub-fertility or infertility, insufficient understanding of Dutch, or adverse social circumstances.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-jan-2000
- planned closingdate31-dec-2005
- Target number of participants4800
- InterventionsIn the intervention group women 18-40 years received an invitation for preconception counseling. When interested and contemplating a pregnancy within a year a risk-assessment questionnaire was used to systematically assess risks of the couple. Counseling was provided based on risks identified as well as risk, which apply to all women. The control group received care as usual.
- Primary outcomeThe effect of GP-initiated preconception counseling (PCC) on adverse pregnancy outcome. (Spontaneous abortion, preterm birth, low birth weight, perinatal death, congenital anomaly).
- Secondary outcomeEvaluation of women’s knowledge of risk factors the foetus and the influence of PCC on this knowledge. Prevalence of risk factors, response to invitation of PCC, anxiety induction by invitation or counseling, satisfaction with counseling. Influence of PCC on risk-reducing behavior. GP satisfaction with the systematic PCC program and barriers for implication.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD. K.M. Pal, van der-de Bruin
- CONTACT for SCIENTIFIC QUERIESPhD. K.M. Pal, van der-de Bruin
- Sponsor/Initiator TNO Quality of Life, Division of Child Health, Prevention and Physical Activity, Leiden University Medical Center (LUMC), Department of General Practice and Nursing Home Medicine
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications1. BMC Fam Pract. 2006 Jul 7;7:41.
2. BMC Fam Pract. 2006 Nov 3;7:66.
- Brief summary'Parents to be' is a project that evaluates routine preconception advice and counselling given to couples before pregnancy (PAC), initiated and given by their own general practitioner (GP) in order to prevent adverse pregnancy outcomes. The couples' personal situation is evaluated with respect to risk factors for the pregnancy and the unborn child. Questions are asked about the couples' medical history, medication, lifestyle (smoking, alcohol consumption and nutritional habits) as well as about hereditary and congenital disorders in the family. If specific risk factors are found the couple receives information about these personal risk factors along with information on general risk factors for pregnancy. The GP offers general and specific health education and refers to a specialist if genetic counselling is needed. The effect of routine PAC on health behaviour, risk perception, frequency of risk factors in the general population is studied.
- Main changes (audit trail)
- RECORD14-okt-2005 - 9-okt-2008


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