Trial name or title |
The Calcium and Pre‐eclampsia (CAP) Study. |
Methods |
Double‐blind, placebo‐controlled randomised clinical trial. |
Participants |
Non‐pregnant women with pre‐eclampsia in their most recent pregnancy. |
Interventions |
Elemental calcium 500 mg as calcium carbonate daily from enrolment until 20 weeks' gestation, versus placebo. |
Outcomes |
Primary: pre‐eclampsia. Secondary: pregnancy loss or pre‐eclampsia; severe maternal morbidity and mortality index; conception; pregnancy loss; no conception during study period; pregnancy loss before 24 weeks' gestational age; pregnancy loss/stillbirth; gestational hypertension; gestational proteinuria; severe gestational hypertension; early onset pre‐eclampsia; severe pre‐eclampsia; moderately severe thrombocytopenia; uric acid > reference values for gestational age; renal failure; pulmonary oedema; cerebrovascular accident; liver failure; intensive care unit admission > 24 hour; eclampsia; HELLP syndrome; placental abruption; maternal death; mother’s hospital stay 7 days or more after birth; caesarean section; severe pre‐eclamptic complications index; birthweight < 2500 g; preterm birth; early preterm birth; Apgar score less than 7 at 5 minutes; death or admission to neonatal intensive care unit for 24 hours or more; stillbirth; pregnancy loss, stillbirth or neonatal death before discharge. |
Starting date |
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Contact information |
GJ Hofmeyr, Effective Care REsearch Unit, University of the Witwatersrand/Fort Hare; Eastern Cape Department of Health. justhof@gmail.com |
Notes |
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