Low Dose Calcium to Prevent Preeclampsia

Study Overview
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Brief Summary
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The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.

Official Title
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Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study

Conditions
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Pre-Eclampsia, Hypertension, Pregnancy-Induced, Dietary Calcium Deficiency

Intervention / Treatment
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* Dietary Supplement: calcium
* Behavioral: Educational sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capacity to understand verbal and visual instructions Gestational age 16 - 20 weeks Live fetus Exclusion Criteria: Hyperparathyroidism or other contra-indication to calcium supplementation Gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis) Use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones) Women already taking calcium supplements or daily antacids at recruitment

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 55 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
Interventional Model Description: cluster randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education<br>Educational sessions | Behavioral: Educational sessions<br>* Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally<br>* Other names: Dietary counseling;|
| Experimental: Education plus supplement<br>Educational sessions and 500 mg calcium per day | Dietary Supplement: calcium<br>* one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)<br>Behavioral: Educational sessions<br>* Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally<br>* Other names: Dietary counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preeclampsia | New onset of hypertension plus proteinuria after 20 weeks of pregnancy | at 20-40 weeks of pregnancy | 
| Hypertensive disorders of pregnancy | New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy | at 20-40 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in dietary calcium intake | At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated. | at 30-36 weeks of pregnancy | 
| Hospital admission due to hypertension | Admission (before labor) due to hypertension | at 20-40 weeks of pregnancy | 
| Severe maternal morbidity | Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome | at 20-40 weeks of pregnancy | 
| Maternal mortality | any cause maternal mortality | starting at 20 weeks up to hospital discharge | 
| Gastrointestinal side effects of calcium | incidence of flatulence, obstipation or other symptoms any time up to delivery | at 20-40 weeks of pregnancy | 
| Maternal admission to Intensive Care Unit | admission for any cause | at 20-40 weeks of pregnancy | 
| Admission to Neonatal Intensive Care Unit | admission for any cause | from delivery to infant discharge | 
| Preterm birth | Delivery before 37 weeks | at 20-36 weeks | 
| Low birth weight | Birth weight less than 2500 g | at 20-40 weeks | 
| Small for gestational age infant | Birth of an infant whose weight is below the 10th percentile for gestational age | at 20-40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium, Dietary supplements, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Nutritional education, Diet therapy, Diet records, Hospitalization, Maternal mortality