Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT02706158
Status:
UNKNOWN
Last Update Posted:
2016-03-15
First Post:
2016-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intervention Program for Pre-eclampsia in Women at Risk
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Testing the Effect of a Dietary Intervention Program on the Incidence of Pre-eclampsia in Women at Risk
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors.
Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.
In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.
Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.
In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.
Detailed Description:
Aims: Pre-eclampsia is one of the leading causes of maternal and perinatal morbidity and mortality worldwide. Preeclampsia frequency is 2-8% from all pregnancies. Dietary factors and dietary status have been suggested to play a role in development of preeclampsia. Low intake of nutrients such as calcium, vitamin D, magnesium, omega 3 fatty acids, is related to increased risk of preeclampsia. Also high triglyceride levels, high BMI, low Omega 6: omega 3 ratio and high calories consumption are possible risk factors.
Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.
In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.
Material and Methods: A prospective study will be carried out. Woman medically diagnosed as high risk for preeclampsia will randomly be assigned to dietary treatment or no dietary treatment groups. In the dietary treatment group, besides medical care, all woman will get calcium and vitamin D supplementation from 8th to 16th gestational weeks, and thereafter until delivery personal extensive nutritional guidance. A 3 day food diary will be collected at inclusion and thereafter at Gestational weeks 16 and 28. All routinely collected data during pregnancy (blood tests, weight, blood pressure and preeclampsia symptoms) will be documented.
In both groups incidence of pre-eclampsia and eclampsia, blood pressure and protein in urine will be recorded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: