Dietary Intervention Program for Pre-eclampsia in Women at Risk

Rambam Health Care Campus

Status: Unknown

Conditions: Pre-eclampsia

Treatments: Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 months; Behavioral: balanced diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02706158

310-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• high risk of preeclampsia

Exclusion criteria

• age below 18
• low risk of preeclampsia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

supplement and balanced diet

Experimental group

Description:

Woman at high risk of pre-eclampsia: supplements. 1500 mg Calcium and 1200 IU Vitamin D for 2 months. balanced diet.

Treatment:

Behavioral: balanced diet

Dietary Supplement: 1500 mg Calcium and 1200 IU Vitamin D for 2 months

women without nutrition or supplement intervention

No Intervention group

Description:

usual follow-up in the gynecology out patient clinic, without nutrition or supplement intervention.