Efficacy of folic acid at high doses in preventing congenital anomalies. Randomized clinical trial in fertile women who plan a pregnancy: folic acid 4mg vs 0.4mg. - ND

Conditions: Prevention of congenital anomalies in pregnancy.
MedDRA version: 9.1Level: HLGTClassification code 10016849Term: Foetal complications

Registration Number: EUCTR2008-004334-25-IT

Lead Sponsor: AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Fertile women aged between 18 and 44 years that plan a pregnancy.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women will be excluded if:
a)are already pregnant
b)do not plan a pregnancy
c)are epileptic (even if treated with anti-epileptic drugs)
d)are diabetic
e)have a history of cancer or of other relevant diseases (Crohn?s disease, ulcerative colitis, rheumatoid arthritis)
f)assume or have assumed anti-folic drugs such as methotrexate
g)are obese
h)have had a previous pregnancy resulted in neural-tube defects or other congenital anormalies
i)have a relative with a neural-tube defect
l)are allergic to folic acid
m)have contraindication to folic acid assumption

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of periconceptional supplementation with folic acid 4 mg/die vs 0.4 mg/die on incidence rate of congenital anomalies.;Secondary Objective: ·To evaluate clinical seriousness of congenital anomalies which will be observed, in order to understand if assuming a higher dose of folic acid may determine a less serious pattern (eg: more lumbosacral than thoracic bifid spines; more uncomplicated than complicated cardiopathias);<br>·To evaluate the rate of additional positive effects on pregnancy (reduction of: spontaneous abortion, recurrent spontaneous abortion, intrauterine retardation, pre-eclampsia, mazolysis, intrauterine death) or of possible adverse effects (increase of dizygotic twins.;Primary end point(s): Rate of congenital anomalies.

Secondary Outcome Measures