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Created on : 25 Jan 2019
Modified on : 25 Jan 2019

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Bibliographical entry (without author) :

Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial. The Lancet, 393, 10169, p. 330-339, January 26

Author(s) :

G Justus Hofmeyr, Ana Pilar Betrán, Mandisa Singata-Madliki, Gabriela Cormick, Stephen P Munjanja, Susan Fawcus, Simpiwe Mose, David Hall, Alvaro Ciganda, Armando H Seuc, Theresa A Lawrie, Eduardo Bergel, James M Roberts, Peter von Dadelszen, José M Belizán

Year of publication :

2019

URL(s) :

https://www.thelancet.com/journals/lancet/article/…
https://doi.org/10.1016/S0140-6736(18)31818-X

Résumé (français)  :

Abstract (English)  :

Background
Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia; however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis that calcium supplementation before and in early pregnancy (up to 20 weeks’ gestation) prevents the development of pre-eclampsia

Methods
We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa, Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or placebo daily from enrolment prepregnancy until 20 weeks’ gestation. Participants were parous women whose most recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant. All participants received unblinded calcium 1·5 g daily after 20 weeks’ gestation. The allocation sequence (1: 1 ratio) used computer-generated random numbers in balanced blocks of variable size. The primary outcome was pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017.

Findings
Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo; 331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of 678 versus 283 of 677 had pregnancies beyond 20 weeks’ gestation. Pre-eclampsia occurred in 69 (23%) of 296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies beyond 20 weeks’ gestation (risk ratio [RR] 0·80, 95% CI 0·61–1·06; p=0·121). For participants with compliance of more than 80% from the last visit before pregnancy to 20 weeks’ gestation, the pre-eclampsia risk was 30 (21%) of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44–0·98; p=0·037). There were no serious adverse effects of calcium reported.

Interpretation
Calcium supplementation that commenced before pregnancy until 20 weeks’ gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large effect size, we cannot rule out a small to moderate effect of this intervention.

Sumário (português)  :

Resumen (español)  :

Full text (public) :

Comments :

Argument (français) :

La supplémentation en calcium qui a débuté avant la grossesse jusqu’à 20 semaines de grossesse, par rapport au placebo, n’a pas montré de réduction significative du nombre de prééclampsies récidivantes.

Argument (English):

Calcium supplementation that commenced before pregnancy until 20 weeks’ gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia

Argumento (português):

A suplementação de cálcio que começou antes da gravidez até a 20ª semana de gestação, em comparação com o placebo, não mostrou uma redução significativa na pré-eclâmpsia recorrente

Argumento (español):

Keywords :

➡ eclampsia (pre-) ; diet/nutrition

Author of this record :

Bernard Bel — 25 Jan 2019