Effect of folic acid on birth defect and preterm birth

• Conditions: congenital anomalies; MedDRA version: 14.1Level: LLTClassification code 10004953Term: Birth prematureSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 14.1Level: HLTClassification code 10007607Term: Cardiac septal defects congenitalSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: PTClassification code 10041524Term: Spina bifidaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-003325-10-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-10
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

When the participant appears to have a multiple pregnancy, she will be excluded for further participation, because these women are advised by midwifes to use 1 mg FA. 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 epilepsy, 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.

;
When the participant appears to have a multiple pregnancy, she will be excluded for further participation, because these women are advised by midwifes to use 1 mg FA. 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 epilepsy, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified