Prevention of congenital anomalies in pregnancy. MedDRA version: 9.1 Level: HLGT Classification code 10016849 Term: Foetal complications
Conditions
Interventions
Trade Name: FERTIFOL
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Folic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Trade Name: FERTIFOL
Pha
Sponsors
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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); ·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. | — |
Countries
Italy
Outcome results
None listed