WHO randomized trial of calcium supplementation before pregnancy to reduce recurrent pre-eclampsia

Conditions

Nutritional, Metabolic, Endocrine Pregnancy and Childbirth calcium supplementation for pre-eclampsia

Hofmeyr GJ, Seuc A, Betrán AP, Cormick G, Singata M, Fawcus S, Mose S, Frank K, Hall D, Belizán J, Roberts JM, Magee LA, von Dadelszen P, Calcium, Pre-eclampsia Study Group.

2020-12-039 citations

10.1016/j.preghy.2020.11.012

Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial.

Hofmeyr GJ, Betrán AP, Singata-Madliki M, Cormick G, Munjanja SP, Fawcus S, Mose S, Hall D, Ciganda A, Seuc AH, Lawrie TA, Bergel E, Roberts JM, von Dadelszen P, Belizán JM, Calcium and Pre-eclampsia Study Group.

2019-01-0185 citations

10.1016/s0140-6736(18)31818-x

Are women with history of pre-eclampsia starting a new pregnancy in good nutritional status in South Africa and Zimbabwe?

Cormick G, Betrán AP, Harbron J, Dannemann Purnat T, Parker C, Hall D, Seuc AH, Roberts JM, Belizán JM, Hofmeyr GJ, Calcium and Pre-eclampsia Study Group.

2018-06-1512 citations

10.1186/s12884-018-1885-z

Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial

Theresa A Lawrie, Ana Pilar Betrán, Mandisa Singata‐Madliki, Álvaro Ciganda, G Justus Hofmeyr et al. (11 authors)

Trials2017-10-2610 citations

10.1186/s13063-017-2220-0

The effect of calcium supplementation on blood pressure in non-pregnant women with previous pre-eclampsia: An exploratory, randomized placebo controlled study

G Justus Hofmeyr, Armando Seuc, Ana Pilar Betrán, Tina D Purnat, Álvaro Ciganda et al. (17 authors)

Pregnancy Hypertension2015-04-1542 citations

10.1016/j.preghy.2015.04.001

Interventions

Calcium Supplementation

Control

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Previous pre-eclampsia or eclampsia in most recent pregnancy 2. Planning to get pregnant

Exclusion criteria

Exclusion criteria: 1. No history of pre-eclampsia or eclampsia 2. Age <18 years 3. Chronic hypertension 4. Already pregnant 5. Taking calcium supplementation 6. History or symptoms of urolithiasis, renal disease or parathyroid disease 7. Not in a sexual relationship 8. Using long-term contraception (eg hormonal, IUD, sterilization) 9. Unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
Pre-eclampsia;Pre-eclampsia or pregnancy loss before labor at any gestation;Severe maternal morbidity and mortality index: defined as one or more of the secondary outcomes	—

Secondary

Measure	Time frame
No conception during study period;Pregnancy loss before labour;Gestational hypertension ;Gestational proteinuria;HELLP Syndrome;ICU admission greater than 24 hours;Severe gestational hypertension;Early onset pre-eclampsia (at less than 32 weeks);Severe pre-eclampsia;Moderately severe thrombocytopenia;Uric acid greater or equal to values for gestational age;Renal Failure defined as creatinine greater than or equal to 120mmol per liter;Pulmonary oedema;Cerebrovascular accident;Liver failure defined as AST greater than or equal to 70 U per L;Ecplampsia;Placental abruption;maternal death;Mothers hospital stay lasts 7 days or more after birth;Caesarean Section;Birthweight less than 2500g;Preterm birth less than 37 weeks gestation;Early preterm birth less than 32 weeks gestation;Apgar score less than 7 at five minutes;Death or admission ot neonatal unit ICU for 24 hours or more;Stillbirth;Pregnancy loss, stillbirth or neonatal death before discharge;Pregnancy loss, stillbirth or neonatal death before 6 weeks;Compliance from enrolment to 20 weeks;Composite outcome used in previous WHO Calsium trial	—

Measure

Time frame

No conception during study period;Pregnancy loss before labour;Gestational hypertension ;Gestational proteinuria;HELLP Syndrome;ICU admission greater than 24 hours;Severe gestational hypertension;Early onset pre-eclampsia (at less than 32 weeks);Severe pre-eclampsia;Moderately severe thrombocytopenia;Uric acid greater or equal to values for gestational age;Renal Failure defined as creatinine greater than or equal to 120mmol per liter;Pulmonary oedema;Cerebrovascular accident;Liver failure defined as AST greater than or equal to 70 U per L;Ecplampsia;Placental abruption;maternal death;Mothers hospital stay lasts 7 days or more after birth;Caesarean Section;Birthweight less than 2500g;Preterm birth less than 37 weeks gestation;Early preterm birth less than 32 weeks gestation;Apgar score less than 7 at five minutes;Death or admission ot neonatal unit ICU for 24 hours or more;Stillbirth;Pregnancy loss, stillbirth or neonatal death before discharge;Pregnancy loss, stillbirth or neonatal death before 6 weeks;Compliance from enrolment to 20 weeks;Composite outcome used in previous WHO Calsium trial

—

Countries

South Africa, Zimbabwe

Contacts

Public ContactGJ Hofmeyr

Principal Investigator

justhof@gmail.com+27 83 280 9402

Outcome results

None listed