'Parents to Be' - The effectiveness of systematic population-based preconception advice and counselling initiated by GPs
| ISRCTN | ISRCTN53942912 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53942912 |
| Protocol serial number | ZonMw Project number 22000044 and 2200.0135; NTR456 |
| Sponsor | TNO Quality of Life, Division of Child Health, Prevention and Physical Activity (The Netherlands) |
| Funder | ZonMw |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 02/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr K.M. Pal, van der-de Bruin
Scientific
Scientific
TNO Quality of Life
P.O. Box 2215
Leiden
2301 CE
Netherlands
| Phone | +31 (0)71 5181836 |
|---|---|
| KM.vanderPal@pg.tno.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | GP-initiated preconception counselling |
| Study acronym | Parents to Be |
| Study objectives | 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(s) | Ethics approval received from the Medical Ethics Committee of Leiden University Medical Centre. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | The effect of GP-initiated preconception counselling (PCC) on adverse pregnancy outcome (spontaneous abortion, preterm birth, low birth weight, perinatal death, congenital anomaly). |
| Key secondary outcome measure(s) | 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 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 4800 |
| Key inclusion criteria | Women aged 18 - 40 years. |
| Key exclusion criteria | 1. Completed family 2. Uterus extirpation 3. Sub-fertility or infertility 4. Insufficient understanding of Dutch 5. Adverse social circumstances |
| Date of first enrolment | 09/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
TNO Quality of Life
Leiden
2301 CE
Netherlands
2301 CE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/07/2006 | Yes | No | ||
| Results article | 03/11/2006 | Yes | No |
Editorial Notes
02/11/2022: Internal review.
