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| Name | Class |
|---|---|
| PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde) | UNKNOWN |
| FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas) | UNKNOWN |
| Universidade Federal do Amazonas | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Active Comparator | Educational sessions |
|
| Education plus supplement | Experimental | Educational sessions and 500 mg calcium per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium | Dietary Supplement | one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Regina Torloni, MD, PhD | Sao Paulo Federal University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal do Amazonas | Manaus | Amazonas | 69077000 | Brazil |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| D063130 | Maternal Death |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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cluster randomized
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| Educational sessions | Behavioral | 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 |
|
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D063129 | Parental Death |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |