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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,040
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
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
Universidade Federal do Amazonas
Manaus, Amazonas, Brazil
Preeclampsia
New onset of hypertension plus proteinuria after 20 weeks of pregnancy
Time frame: at 20-40 weeks of pregnancy
Hypertensive disorders of pregnancy
New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy
Time frame: at 20-40 weeks of pregnancy
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.
Time frame: at 30-36 weeks of pregnancy
Hospital admission due to hypertension
Admission (before labor) due to hypertension
Time frame: at 20-40 weeks of pregnancy
Severe maternal morbidity
Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome
Time frame: at 20-40 weeks of pregnancy
Maternal mortality
any cause maternal mortality
Time frame: 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
Time frame: at 20-40 weeks of pregnancy
Maternal admission to Intensive Care Unit
admission for any cause
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Time frame: at 20-40 weeks of pregnancy
Admission to Neonatal Intensive Care Unit
admission for any cause
Time frame: from delivery to infant discharge
Preterm birth
Delivery before 37 weeks
Time frame: at 20-36 weeks
Low birth weight
Birth weight less than 2500 g
Time frame: at 20-40 weeks
Small for gestational age infant
Birth of an infant whose weight is below the 10th percentile for gestational age
Time frame: at 20-40 weeks