PMC:2952583 / 12975-17882
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/2952583","sourcedb":"PMC","sourceid":"2952583","source_url":"https://www.ncbi.nlm.nih.gov/pmc/2952583","text":"Characteristics of the Study Subjects\nA total of 2614 serum samples were available to assay. Eight women did not have a study entry sample available for analysis and their fifteen subsequent samples were excluded. Therefore, a total of 2,599 samples were available for this analysis (diabetes, n = 524; chronic hypertension, n = 827; multifetal gestation, n = 574; and previous preeclampsia, n = 674) from 993 women (diabetes, n = 194; chronic hypertension, n = 313; multifetal gestation, n = 234; and previous preeclampsia, n = 252). The original trial included 2,539 women so this analysis represents 39% of the women originally studied. Within each of the high-risk groups, women in this analysis (i.e. women with samples) were similar to women not included (i.e. without samples) for the following characteristics: primigravida, smoking, maternal age and body mass index. There were fewer African American and more Caucasian in the diabetes group and fewer other and more Caucasian in the multifetal group compared to women without a sample. The gestational age at study entry was also slightly earlier in women with samples in the multifetal gestation group compared to women without a sample. Lastly, blood pressure at study entry was slightly lower in women with chronic hypertension and slightly higher in multifetal gestation compared to women without a sample (data not shown).\nThe characteristics of the 993 study subjects are shown in Table 1. The incidence of preeclampsia in the high-risk groups was 46 of 194 (23.7%) for subjects with diabetes, 78 of 313 (24.9%) for subjects with chronic hypertension, 39 of 234 (16.7%) for subjects with multifetal gestations, and 50 of 252 (19.8%) for subjects with previous preeclampsia. Within this cohort, only 40 subjects (4.0%) were identified as having the onset of preeclampsia before 34 weeks' gestation. The number of samples available within each of the high-risk groups was too few to analyze by early onset of preeclampsia (3 of the 4 risk groups had n\u003c7).\nTable 1 Study Subject Information According to High-Risk Group.\nDiabetes (n = 194) Chronic Hypertension (n = 313) Multifetal Gestation (n = 234) Previous Preeclampsia (n = 252)\nCharacteristic Control (n = 148) Preeclampsia (n = 46) Control (n = 235) Preeclampsia (n = 78) Control (n = 195) Preeclampsia (n = 39) Control (n = 202) Preeclampsia (n = 50)\nMaternal age (years) 26±6 26±6 29±7 30±6 25±6 26±7 24±5 25±6\nBody-mass index (kg/m2) 28±7 27±8 33±9 34±9 26±7 29±8 28±8 30±9\nGestational ageat study entry (weeks) 17±3 19±4 19±4 19±4 21±3 20±4 20±4 19±4\nPrimigravida, no. (%) 46 (31) 20 (43) 49 (21) 16 (21) 53 (27) 19 (49)* --- ---\nRace or ethnic group, no. (%) *\nBlack 42 (28) 19 (41) 148 (63) 49 (63) 92 (47) 22 (56) 153 (76) 37 (74)\nWhite 91 (61) 27 (59) 65 (28) 18 (23) 78 (40) 14 (36) 42 (21) 13 (26)\nHispanic/Other 15 (10) 0 (0) 22 (9) 11 (14) 25 (13) 3 (8) 7 (3) 0 (0)\nAverage blood pressure at entry (mmHg) 112±14/67±10 118±15*/70±12 126±15/76±12 132±13*/81±11* 111±11/64±9 116±9*/67±9* 110±11/65±10 115±12*/70±9*\nSmoked during pregnancy,no. (%) 34 (23) 5 (11) 40 (17) 13 (17) 28 (14) 3 (8) 31 (15) 9 (18)\nAspirin treatment,no. (%) 78 (53) 18 (39) 112 (48) 44 (56) 101 (52) 14 (36) 102 (50) 23 (46)\nGestational age at delivery (weeks) 37±2 36±2 38±2 36±3* 35±3 35±2 38±2 37±2*\nGestational age at delivery \u003c37 weeks 46 (31) 23 (50)* 46 (20) 35 (45)* 122 (63) 28 (72) 30 (15) 16 (32)*\nOnset of preeclampsia before 37 weeks' gestation, no. (%) --- 30 (65) --- 52 (67) --- 27 (69) --- 19 (38)\nInfant birth weight (grams) 3288±782 3162±943 3120±689 2797±907* 2334±607 2461±458 3189±642 3135±729\nData are mean ± standard deviation or N (%).\n*: p\u003c0.05 compared to group appropriate control. Overall, there was no difference in maternal age, body mass index, or gestational age at study entry between the preeclamptic subjects within each high-risk group and their representative controls. The preeclamptic subjects in each high-risk group exhibited a modest but statistically significant higher average blood pressure at study entry compared with their representative controls.\nThe original trial of low-dose aspirin in high-risk patients indicated no effect of aspirin on outcome. In this study, the overall incidence of preeclampsia was not significantly different in the aspirin and placebo treated groups (20% versus 23%, p = 0.31). This was also true in the individual high-risk groups (p≥0.05). In addition, there was no difference in the concentrations of sFlt1, sEng and PlGF between women who were in the aspirin treatment group and those in the placebo group (p≥0.05). Formal tests for interaction between treatment group and the markers were not significant. For these reasons, aspirin treated and placebo groups were combined for these 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