Neural Tube Defects (NTDs) Congenital Anomalies Preterm Birth Preeclampsia Folic Acid supplementation Neuralebuisdefect aangeboren aandoening/aangeboren afwijking vroeggeboorte pre-eclampsie/zwangerschapsvergiftiging Foliumzuursuppletie
Conditions
Interventions
Women in all intervention groups will receive identical pills, containing two different doses of folic acid (0.4 or 4.0 mg). Women will start taking the pills after randomisation, but at least 4 weeks
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: All women living in the Northern region of the Netherlands of 18 to 45 years old who want to become pregnant within 12 months are eligible for participation in the study. Women followed by an assisted reproduction centre are not excluded.
Exclusion criteria
Exclusion criteria: 1. No informed consent given; 2. Not understanding Dutch; 3. Already pregnant at time of inclusion or within 4 weeks after start intervention; 4. Planning to move to an area where the study is not implemented; 5. Recently or at present using folic acid antagonists or antifolates or other drugs influencing the folic acid metabolism (anti-epileptica, methotrexaat, pyrimethamine, trimethoprim); 6. Being affected by diabetes, megaloblastic anaemia and/or cancer (previous cancer or abnormal PAP smears); 7. Being allergic to folic acid or any other ingredient of the pills used in this study; 8. Take defined dosages of folic acid for directions other than those listed in the above exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are: FA related congenital anomalies and preterm birth. Information on all congenital anomalies of live births, stillbirths and terminations of pregnancy following prenatal diagnosis will be derived from the database of EUROCAT, where virtually all congenital anomalies are registered. Data about the diagnosis and the medical history are collected in a standardized procedure of high quality. FA related congenital anomalies are neural tube defects, heart anomalies, limb defects, urinary tract malformations, oral cleft and Down syndrome. The congenital anomalies will be classified according to the guidelines for case classification by Rasmussen et al (2003). Preterm birth is defined as a gestational age < 37 weeks. Gestational age will be assessed from the medical records. Medical terminations will also be included, to avoid bias toward the null hypothesis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Birth weight, obtained from medical records; 2. Preeclampsia (defined as a systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg after 20 weeks of gestation among women with previously normal blood pressure, combined with proteinuria (> 300 mg/24 hours)), obtained from medical records; 3. Compliance with intervention. | — |
Contacts
Public ContactFenneke Blom
Van der boechorststraat 7, H443
Outcome results
None listed