Het Foliumzuur-Extra bij kinderwens en zwangerschap onderzoek Noord-Nederland.
Recruiting
- Conditions
- eural Tube Defects (NTDs)Congenital AnomaliesPreterm BirthPreeclampsiaFolic Acid supplementationNeuralebuisdefectaangeboren aandoening/aangeboren afwijkingvroeggeboortepre-eclampsie/zwangerschapsvergiftigingFoliumzuursuppletie
- Registration Number
- NL-OMON26064
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5000
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
1. No informed consent given;
2. Not understanding Dutch;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measures are: FA related congenital anomalies and preterm birth.<br>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).<br>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 Outcome Measures
Name Time Method 1. Birth weight, obtained from medical records;<br /><br>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;<br /><br>3. Compliance with intervention.