The results of ten clinical trials suggest that supplemental calcium may prevent preeclampsia. Methodologic problems, however, and differences in study design limit the credibility of the results and their generalizability to other patient populations. Moreover, none of the trials has reported the outcome of systematic surveillance for urolithiasis, an important possible complication of treatment. In response to the need for a definitive evaluation of the effects of calcium supplementation, NICHD has conducted a trial at five U.S. university medical centers. Healthy nulliparous patients were randomly assigned to receive either 2 g ingested supplemental calcium daily (n=2250) or placebo (n=2250) in a double-blind study. Medication was administered beginning between 13 and 21 completed weeks of gestation and continued until the termination of pregnancy. Monitoring for the major study endpoints - pregnancy-associated hypertension and proteinuria, preeclampsia, eclampsia, and HELLP syndrome - and for urolithiasis was systematic, standardized, and thorough. It included measurement of blood pressure, proteinuria, and hematuria at uniformly scheduled prenatal clinic visits and surveillance for hypertension and proteinuria during labor, delivery, and the first 24 hours postpartum. CPEP has adequate statistical power to detect a reduction of 43 percent in preeclampsia risk in the calcium group.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Intramural Research (Z01)
Project #
1Z01HD000373-08
Application #
2575616
Study Section
Epidemiology and Biometry Training Committee (EB)
Project Start
Project End
Budget Start
Budget End
Support Year
8
Fiscal Year
1996
Total Cost
Indirect Cost
City
State
Country
United States
Zip Code
England, Lucinda J; Grauman, Alyssa; Qian, Cong et al. (2007) Misclassification of maternal smoking status and its effects on an epidemiologic study of pregnancy outcomes. Nicotine Tob Res 9:1005-13
Tjoa, May Lee; Levine, Richard J; Karumanchi, S Ananth (2007) Angiogenic factors and preeclampsia. Front Biosci 12:2395-402
Rana, Sarosh; Karumanchi, S Ananth; Levine, Richard J et al. (2007) Sequential changes in antiangiogenic factors in early pregnancy and risk of developing preeclampsia. Hypertension 50:137-42
Levine, Richard J; Lam, Chun; Qian, Cong et al. (2006) Soluble endoglin and other circulating antiangiogenic factors in preeclampsia. N Engl J Med 355:992-1005
Levine, Richard J; Qian, Cong; Maynard, Sharon E et al. (2006) Serum sFlt1 concentration during preeclampsia and mid trimester blood pressure in healthy nulliparous women. Am J Obstet Gynecol 194:1034-41
Bdolah, Yuval; Palomaki, Glenn E; Yaron, Yuval et al. (2006) Circulating angiogenic proteins in trisomy 13. Am J Obstet Gynecol 194:239-45
Signore, Caroline; Mills, James L; Qian, Cong et al. (2006) Circulating angiogenic factors and placental abruption. Obstet Gynecol 108:338-44
Levine, Richard J; Thadhani, Ravi; Qian, Cong et al. (2005) Urinary placental growth factor and risk of preeclampsia. JAMA 293:77-85
Levine, Richard J; Karumanchi, S Ananth (2005) Circulating angiogenic factors in preeclampsia. Clin Obstet Gynecol 48:372-86
Levine, Richard J; Qian, Cong; Leshane, Erik S et al. (2004) Two-stage elevation of cell-free fetal DNA in maternal sera before onset of preeclampsia. Am J Obstet Gynecol 190:707-13

Showing the most recent 10 out of 19 publications