Pre-Eclampsia, Hypertension, Pregnancy-Induced, Dietary Calcium Deficiency
Conditions
Keywords
Calcium, Dietary supplements, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Nutritional education, Diet therapy, Diet records, Hospitalization, Maternal mortality
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTcalcium
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
BEHAVIORALEducational sessions
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
Sponsors
PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)
FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)
Universidade Federal do Amazonas
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
cluster randomized
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preeclampsia | at 20-40 weeks of pregnancy | New onset of hypertension plus proteinuria after 20 weeks of pregnancy |
| Hypertensive disorders of pregnancy | at 20-40 weeks of pregnancy | New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe maternal morbidity | at 20-40 weeks of pregnancy | Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome |
| Maternal mortality | starting at 20 weeks up to hospital discharge | any cause maternal mortality |
| Gastrointestinal side effects of calcium | at 20-40 weeks of pregnancy | incidence of flatulence, obstipation or other symptoms any time up to delivery |
| Maternal admission to Intensive Care Unit | at 20-40 weeks of pregnancy | admission for any cause |
| Mean change in dietary calcium intake | at 30-36 weeks of pregnancy | At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated. |
| Preterm birth | at 20-36 weeks | Delivery before 37 weeks |
| Low birth weight | at 20-40 weeks | Birth weight less than 2500 g |
| Small for gestational age infant | at 20-40 weeks | Birth of an infant whose weight is below the 10th percentile for gestational age |
| Admission to Neonatal Intensive Care Unit | from delivery to infant discharge | admission for any cause |
| Hospital admission due to hypertension | at 20-40 weeks of pregnancy | Admission (before labor) due to hypertension |
Countries
Brazil
Outcome results
None listed