A randomized controlled trial on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth - Folic acid Extra

Vrije Universiteit Medisch Centrum0 个研究点目标入组 5,000 人开始时间: 待定最近更新: 2024年7月22日

适应症

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•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 who had previous offspring with NTD and other women who take high doses of FA for any other reason and women who use FA-antagonists will be excluded from the study.
•Further exclusion criteria are:
•a) no informed consent given
•b) not understanding Dutch
•c) already pregnant at time of inclusion or within 4 weeks after start intervention
•d) planning to move to an area where the study is not implemented
•e) recently or at present using folic acid antagonists or antifolates or other drugs influencing the folic acid metabolism (methotrexaat, pyrimethamine, trimethoprim)
•f) being affected by diabetes, megaloblastic anaemia and/or cancer (previous cancer or abnormal PAP smears)
•g) being allergic to folic acid or any other ingredient of the pills used in this study
•h) take defined dosages of folic acid for directions other than those listed in the above exclusion criteria.

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