Cited by 634Pregnancy and preeclampsia studiesNeurological Complications and SyndromesBlood Pressure and Hypertension Studies

Trial of Calcium to Prevent Preeclampsia

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Levine, Richard J., Hauth, John C., Curet, Luis B., Sibai, Baha M., Catalano, Patrick M., Morris, Cynthia D., DerSimonian, Rebecca, Esterlitz, Joy R. +11 more·1997·New England Journal of Medicine

Abstract

BACKGROUND: Previous trials have suggested that calcium supplementation during pregnancy may reduce the risk of preeclampsia. However, differences in study design and a low dietary calcium intake in the populations studied limit acceptance of the data. METHODS: We randomly assigned 4589 healthy nulliparous women who were 13 to 21 weeks pregnant to receive daily treatment with either 2 g of elemental calcium or placebo for the remainder of their pregnancies. Surveillance for preeclampsia was conducted by personnel unaware of treatment-group assignments, using standardized measurements of blood pressure and urinary protein excretion at uniformly scheduled prenatal visits, protocols for monitoring these measurements during the hospitalization for delivery, and reviews of medical records of unscheduled outpatient visits and all hospitalizations. RESULTS: Calcium supplementation did not significantly reduce the incidence or severity of preeclampsia or delay its onset. Preeclampsia occurred in 158 of the 2295 women in the calcium group (6.9 percent) and 168 of the 2294 women in the placebo group (7.3 percent) (relative risk, 0.94; 95 percent confidence interval, 0.76 to 1.16). There were no significant differences between the two groups in the prevalence of pregnancy-associated hypertension without preeclampsia (15.3 percent vs. 17.3 percent) or of all hypertensive disorders (22.2 percent vs. 24.6 percent). The mean systolic and diastolic blood pressures during pregnancy were similar in both groups. Calcium did not reduce the numbers of preterm deliveries, small-for-gestational-age births, or fetal and neonatal deaths; nor did it increase urolithiasis during pregnancy. CONCLUSIONS: Calcium supplementation during pregnancy did not prevent preeclampsia, pregnancy-associated hypertension, or adverse perinatal outcomes in healthy nulliparous women.

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Research works printed but not linked: 9

  1. National High Blood Pressure Education Program Working Group re- port on high blood pressure in pregnancy. Am J Obstet Gynecol 1990;163: 1689-712.
  2. Nutrition of expectant and nursing mothers: interim report of the Peo- ple's League of Health. Lancet 1942;2:10-2.
  3. Chaudhuri SK. Calcium deficiency and toxaemia of pregnancy. J Obstet Gynaecol India 1969;19:313-6.
  4. Montanaro D, Boscutti G, Antonucci F, et al. Prevention of pregnan- cy-induced hypertension (P.I.H.) and preeclampsia (P.E.) by oral calcium supplementation: preliminary results. Miner Metab Res Italy 1986;7:121- 4.
  5. Duley L. Prevention and treatment of pre-eclampsia. Oxford Database of Perinatal Trials Newsletter. February 1991:2-4.
  6. Levine RJ, Raymond E, DerSimonian R, Clemens JD. Preeclampsia prevention with calcium supplementation. Clin Appl Nutr 1992;2:30-8.
  7. Hoffman RJ, Feld RD. A modified procedure for creatinine (CRT) which eliminates bilirubin (BILT) interference on the Hitachi 737. Clin Chem 1988;34:1313. abstract.
  8. Calcium and hypocalcemia. In: Klaus MH, Fanaroff AA, eds. Care of the high-risk neonate. 3rd ed. Philadelphia: W.B. Saunders, 1986:227-31.
  9. Villar J, Repke J, Belizan JM, Pareja G. Calcium supplementation re- duces blood pressure during pregnancy: results of a randomized controlled clinical trial. Obstet Gynecol 1987;70:317-22.

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Authors
Levine, R. J., Hauth, J. C., Curet, L. B., Sibai, B. M., Catalano, P. M., Morris, C. D., DerSimonian, R., Esterlitz, J. R., Raymond, E. G., Bild, D. E., Clemens, J. D., Cutler, J. A., Ewell, M. G., Friedman, S. A., Goldenberg, R. L., Jacobson, S.-L., Joffe, G. M., Klebanoff, M. A., & Petrulis, A. S.
Affiliations
  • National Institutes of Health (US)
  • University of Alabama at Birmingham (US)
  • University of New Mexico (US)
  • University of Tennessee Health Science Center (US)
  • MetroHealth Medical Center (US)
  • Oregon Health & Science University (US)
  • National Heart, Lung, and Blood Institute (US)
Venue
New England Journal of Medicine
Published
1997-07-10
Volume
337
Issue
2
Pages
69-77
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2084688828
Cited by
634
References
33
Citations by year
2026: 6 · 2025: 6 · 2024: 11 · 2023: 11 · 2022: 14 · 2021: 17 · 2020: 13 · 2019: 11 · 2018: 19 · 2017: 12 · 2016: 11 · 2015: 16 · 2014: 26 · 2013: 22 · 2012: 34
FWCI
45.62
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
Eunice Kennedy Shriver National Institute of Child Health and Human Development (N01-HD-5-3122, N01-HD-5-3121, N01-HD-5-3123)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
  • Health Sciences › Medicine › Psychiatry and Mental health › Neurological Complications and Syndromes
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
Keywords
calcium supplementation, preeclampsia prevention, pregnancy, nulliparous women, gestational hypertension, hypertensive disorders of pregnancy, blood pressure in pregnancy, urinary protein excretion, urolithiasis, perinatal outcomes, preterm birth, small for gestational age
MeSH terms
Adult, Calcium, Female, Humans, Hypertension, Parity, Pre-Eclampsia, Pregnancy, Pregnancy Complications, Cardiovascular, Pregnancy Outcome, Proteinuria, United States, Urinary Calculi, Incidence, Case-Control Studies

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