Dietary Intervention Program for Pre-eclampsia in Women at Risk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testing the Effect of a Dietary Intervention Program on the Incidence of Pre-eclampsia in Women at Risk

Conditions
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Pre-eclampsia

Intervention / Treatment
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* Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 months
* Behavioral: balanced diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: high risk of preeclampsia Exclusion Criteria: age below 18 low risk of preeclampsia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supplement and balanced diet<br>Woman at high risk of pre-eclampsia: supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet. | Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 months<br>* 1500 mg Calcium and 1200 IU Vitamin D for 2 months<br>* Other names: supplement;Behavioral: balanced diet<br>* participants will get a balanced diet according to pregnancy stage<br>* Other names: diet for pregnancy;|
| No Intervention: women without nutrition or supplement intervention<br>usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower incidence of pre-eclampsia during pregnancy |  | up to 42 weeks gestation | 
| lower incidence of pre-eclampsia post-partum |  | 4 weeks post delivery |