Pregnancy-Induced Hypertension
Conditions
Interventions
The intervention consisted of prescribing 02 calcium tablets containing 500 mg per day for the minimum intervention group (GIMin), 02 calcium tablets of 1,500 mg per day for the maximum intervention g
G07.203.300.456
Sponsors
Universidade Federal de São Paulo
Universidade Federal da Fronteira Sul
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: Pregnant women over 18 years of age; single fetus; primigravidae; diagnosis of gestational hypertension; overweight and/or obesity; be at least 20 weeks pregnant; low socioeconomic factor; low dietary calcium intake (less than 800mg/day); non-use of drugs that interfere with calcium absorption (corticosteroids; thiazides; thyroid hormones)
Exclusion criteria
Exclusion criteria: Pregnant women with polyhydramnios; severe anemia; fetal death; severe preeclampsia; history of hypertension before pregnancy; placental abruption; premature rupture of membranes; abnormal umbilical artery doppler; uteroplacental insufficiency; other pre-existing medical condition; any contraindication to calcium supplementation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- Expected outcome: It is expected to find a significant difference in the intragroup (calcium 500mg/day, calcium 1,500mg/day and placebo group) and intergroup analysis (before the intervention, 4 weeks after and 8 weeks after) with blood pressure reduction systolic blood pressure (SBP) over time.;1- Outcome found: A difference was found between the groups after 8 weeks of supplementation. There was a reduction in systolic blood pressure (SBP) for the supplemented groups when compared to the placebo group (intergroup analysis p< 0.05). Furthermore, there was a significant reduction of 9.4 mmHg in SBP (intragroup analysis p<0.05) after 8 weeks for the calcium 1,500mg/day group and a reduction of 12.3 mmHg for the calcium 500mg/day group.;2- Expected outcome: It is expected to find a significant difference in the intragroup (calcium 500mg/day, calcium 1,500mg/day and placebo group) and intergroup analysis (before the intervention, 4 weeks after and 8 weeks after) with blood pressure reduction diastolic blood pressure (DBP) over time.;2- Outcome found: A difference was found between the groups after 8 weeks of supplementation. There was a reduction in diastolic blood pressure (DBP) for the group supplemented with calcium 500mg/day when compared with the placebo group (intergroup analysis p< 0.05). Still, there was a significant reduction of 9.2 mmHg after 8 weeks (intragroup analysis p<0.05). There were no significant differences for the 1,500mg/day calcium group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 3- Expected outcome: It is expected to find a significant difference in the intragroup (calcium 500mg/day, calcium 1,500mg/day and placebo group) and intergroup analysis (before the intervention, 4 weeks after and 8 weeks after) with a reduction in proteinuria over over time;3- Outcome found: A difference was found between the groups after 8 weeks of supplementation. There was a reduction in proteinuria of 7.2 mg/dl for the calcium 500mg/day group (p=0.002) and a 4.5mg/dl reduction in proteinuria for the calcium 1,500mg/day group (p<0.05) when compared with the placebo group.;4- Expected outcome: It is expected to find a significant difference in the intragroup (calcium 500mg/day, calcium 1,500mg/day and placebo group) and intergroup analysis (before the intervention, 4 weeks after and 8 weeks after) with a reduction in urinary creatinine over time.;4- Outcome found: A difference was found between the groups after 8 weeks of supplementation. There was a reduction in urinary creatinine of 3.2 mg/dl for the calcium 500mg/day group (p=0.008) and 8.6 mg/dl of creatinine for the calcium 1,500mg/day group (p<0.05) when compared with the placebo group.;5- Expected outcome: It is expected to find a significant difference in the intragroup (calcium 500mg/day, calcium 1,500mg/day and placebo group) and intergroup analysis (before the intervention, 4 weeks after and 8 weeks after) with parathyroid hormone reduction ( PTH) over time.;5- Outcome found: A difference was found between the groups after 8 weeks of supplementation. There was a reduction in PTH of 4.7 pg/ml for the calcium 500mg/day group (p<0.05) and 3.1 mg/dl of PTH for the calcium 1,500mg/day group (p<0.05) when compared with the placebo group.;6- Expected outcome: It is expected to find a significant difference in the intragroup (calcium 500mg/day, calcium 1,500mg/day and placebo group) and intergroup analysis (before the intervention, 4 weeks after and 8 weeks after) with an increase in blood calcium over time.;6 | — |
Countries
Brazil
Contacts
Public ContactErica ;Janine Pitilin;Schirmer
Universidade Federal da Fronteira Sul;Universidade Federal de São Paulo
Outcome results
None listed