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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women |
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| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D (25OHD) status in the first trimester | 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 | 11-14 (+6) weeks of amenorrhea |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D status in the third trimester | 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 | 28-40 weeks of amenorrhea |
| Deficit un vitamin D |
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Inclusion Criteria:
Exclusion Criteria:
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Teh vitamin D status will be measured in a large population of french pregnant women (in the first trimester) in order to evaluate the importance of the vitamin D deficency in France and correlate this deficiency with preeclampsia
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra BENACHI, MD/PhD | Antoine Béclère Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoine Béclère Hospital | Clamart | 92141 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32448701 | Result | Salakos E, Rabeony T, Courbebaisse M, Taieb J, Tsatsaris V, Guibourdenche J, Senat MV, Haidar H, Jani JC, Barglazan D, Maisonneuve E, Haguet MC, Winer N, Masson D, Elie C, Souberbielle JC, Benachi A. Relationship between vitamin D status in the first trimester of pregnancy and gestational diabetes mellitus - A nested case-control study. Clin Nutr. 2021 Jan;40(1):79-86. doi: 10.1016/j.clnu.2020.04.028. Epub 2020 Apr 25. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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To evaluate the deficit un vitamin D in a population of pregnant women in the parisian area
| 11-14 (+6) weeks of amenorrhea |
| Calcemia of the newborns | To evaluate the calcemia of the newborns after maternal systematic oral intake of vitamin D | 1 day (At the moment of the Guthrie test) |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |