Neonatal Hypercalcemia, Preeclampsia, Pregnancy, Vitamin D Deficiency Defined as Serum 25OHD < 75 Nmol/l or 30ng/ml
Conditions
Keywords
Preeclampsia, Vitamin D deficiency, Pregnancy, First trimester
Brief summary
Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant women who will develop preeclampsia in the second or third trimester compare to a control group Primary purpose : To determine the vitamin D status in the first trimester in a large population of french pregnant women in order to evaluate the importance of the vitamin D deficiency in France and correlate this deficiency with preeclampsia
Detailed description
Primary purpose : To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia. Secondary purpose : (i)To compare the vitamin D status in the third trimester in a group of patients with preeclampsia and a group of pregnant women without preeclampsia. (ii) To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area. (iii) To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D 100000U at 28 weeks Methodology : Multicenter (6 centers), Cohort, Nested case-control study Protocol : 4500 patients will be recruited. A blood sample will be performed : in the first trimester (11-14 weeks), in the third trimester (28-40 weeks), and cord blood. For each patient with preeclampsia, 4 controls will be taken from the cohort and matched by parity, race/ethnicity, maternal age, season, BMI. The serum concentration of 25OHD will be measured in all samples.A dosage of 25OHD will be performed in 1000 women from the initial cohort in order to calculate the prevalence of vitamin D deficiency.
Interventions
None listed
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant woman * First trimester * Singleton * Affiliated to Social security policy * Woman who gave informed consent
Exclusion criteria
* Hypercalcemia (\>2.65 mmol/l) or any other phosphocalcic disease * Hypertension (\>140/90) from the first trimester * Renal insufficiency (creatinine \> 120µmol/l) * Bone disease (osteogenesis imperfecta…) * Lithium therapy * Bowel malabsorption * Kidney stones
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D (25OHD) status in the first trimester | 11-14 (+6) weeks of amenorrhea | To compare the vitamin D (25OHD) status, in the first trimester, in a group of patients with preeclampsia and a group of pregnant women without preeclampsia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D status in the third trimester | 28-40 weeks of amenorrhea | To compare the vitamin D status in the third trimester in a group of patients with preeclampsia and a group of pregnant women without preeclampsia |
| Deficit un vitamin D | 11-14 (+6) weeks of amenorrhea | To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area |
| Calcemia of the newborns | 1 day (At the moment of the Guthrie test) | To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D |
Countries
France
Outcome results
None listed