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

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dc.contributor.authorHofmeyr, G. Justusen_ZA
dc.contributor.authorBetran, Ana Pilaren_ZA
dc.contributor.authorSingata-Madliki, Mandisaen_ZA
dc.contributor.authorCormick, Gabrielaen_ZA
dc.contributor.authorMunjanja, Stephen P.en_ZA
dc.contributor.authorFawcus, Susanen_ZA
dc.contributor.authorMose, Simpiween_ZA
dc.contributor.authorHall, Daviden_ZA
dc.contributor.authorCiganda, Alvaroen_ZA
dc.contributor.authorSeuc, Armando H.en_ZA
dc.contributor.authorLawrie, Theresa A.en_ZA
dc.contributor.authorBergel, Eduardoen_ZA
dc.contributor.authorRoberts, James M.en_ZA
dc.contributor.authorVon Dadelszen, Peteren_ZA
dc.contributor.authorBelizan, Jose M.en_ZA
dc.contributor.authorCalcium and Pre-eclampsia Study Group
dc.date.accessioned2021-10-13T11:38:35Z
dc.date.available2021-10-13T11:38:35Z
dc.date.issued2019
dc.descriptionCITATION: Hofmeyr, G. J., et al. 2019. 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):P330-339, doi:10.1016/S0140-6736(18)31818-X.
dc.descriptionThe original publication is available at https://www.thelancet.com
dc.description.abstractBackground: 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. ernal and Child Health.en_ZA
dc.description.urihttps://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31818-X/fulltext
dc.description.versionPublisher's version
dc.format.extent10 pagesen_ZA
dc.identifier.citationHofmeyr, G. J., et al. 2019. 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):P330-339, doi:10.1016/S0140-6736(18)31818-X
dc.identifier.issn1474-547X (online)
dc.identifier.issn0140-6736 (print)
dc.identifier.otherdoi:10.1016/S0140-6736(18)31818-X
dc.identifier.urihttp://hdl.handle.net/10019.1/123220
dc.language.isoen_ZAen_ZA
dc.publisherElsevieren_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectPrepregnancy -- Calciumen_ZA
dc.subjectNutrition in pregnancyen_ZA
dc.subjectPreeclampsia -- Risk factorsen_ZA
dc.subjectPlacebos (Medicine)en_ZA
dc.subjectNutritional supplementsen_ZA
dc.titlePrepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia : a multicentre, double-blind, randomised, placebo-controlled trialen_ZA
dc.typeArticleen_ZA
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