Department of Obstetrics and Gynecology, Peking University First Hospital, Beijing 100034, China.
Beijing Key Laboratory of Maternal Fetal Medicine of Gestational Diabetes Mellitus, Beijing 100034, China.
Chin Med J (Engl). 2023 Mar 5;136(5):550-555. doi: 10.1097/CM9.0000000000002545.
The APPEC study is a large-population randomized controlled trial in China evaluating the role of low-dose aspirin prophylactic treatment for pre-eclampsia. There was no statistically significant difference in postpartum hemorrhage (PPH) incidence between the aspirin and control groups. This study aimed to evaluate the potential bleeding risk of 100 mg aspirin in high-risk pregnant women and the difference in the incidence of PPH according to maternal characteristics.
This is a secondary data analysis of the APPEC study. Platelet counts and coagulation test results were collected at five follow-up visits. Subgroups defined by maternal age (<35 years and ≥35 years), pre-pregnancy body mass index (pre-BMI, <28 kg/m 2 and ≥28 kg/m 2 ), parity, gestational age at enrollment, and medical history, including pre-eclampsia, chronic hypertension, and diabetes mellitus, were analyzed. Logistic regression analysis was used to determine the statistical significance of the difference in the incidence of PPH after aspirin administration in pregnant women in each subgroup. Adjustment using multiple logistic regression models followed these analyses. Binary logistic regression was used to determine the relationship between pre-BMI and PPH.
There was no significant difference between the aspirin and control groups in bleeding risk (3.4% [16/464] vs. 3.0% [13/434], T = 0.147, P = 0.701). No significant difference was found in the incidence of PPH in total (relative risk = 1.220, 95% confidence interval [CI] = 0.720-2.067, P = 0.459; aspirin group vs. control group, 6.5% [30/464] vs. 5.3% [23/434], P = 0.459) or in subgroup analysis. A significant correlation between pre-BMI and PPH was found in the aspirin group, while in the control group there was no significant correlation (aspirin group, odds ratio [OR] = 1.086, 95% CI = 1.004-1.175, P = 0.040; control group, OR = 1.060, 95% CI = 0.968-1.161, P = 0.209).
A dosage of 100 mg of aspirin per day, initiated from 12 to 20 gestational weeks until 34 weeks of gestation, did not increase the risk of potential bleeding and PPH regardless of the maternal characteristic. In the aspirin group, the positive correlation between BMI and PPH was significant.
ClinicalTrials.gov, NCT01979627.
APPEC 研究是在中国进行的一项大规模人群随机对照试验，旨在评估小剂量阿司匹林预防性治疗子痫前期的作用。阿司匹林组和对照组产后出血（PPH）的发生率没有统计学差异。本研究旨在评估高危孕妇中 100mg 阿司匹林的潜在出血风险，以及根据产妇特征 PPH 发生率的差异。
这是 APPEC 研究的二次数据分析。在五次随访中收集血小板计数和凝血试验结果。根据产妇年龄（<35 岁和≥35 岁）、孕前体重指数（pre-BMI，<28kg/m 2 和≥28kg/m 2 ）、产次、入组时的孕周以及包括子痫前期、慢性高血压和糖尿病在内的病史，对亚组进行定义。使用逻辑回归分析确定阿司匹林治疗后孕妇在每个亚组中 PPH 发生率的差异是否具有统计学意义。在这些分析之后，采用多元逻辑回归模型进行调整。二项逻辑回归用于确定 pre-BMI 与 PPH 之间的关系。
阿司匹林组和对照组的出血风险无显著差异（3.4%[16/464]vs.3.0%[13/434]，T=0.147，P=0.701）。总 PPH 发生率无显著差异（相对风险=1.220，95%置信区间[CI]=0.720-2.067，P=0.459；阿司匹林组 vs.对照组，6.5%[30/464]vs.5.3%[23/434]，P=0.459）或亚组分析中无显著差异。在阿司匹林组中，pre-BMI 与 PPH 呈显著正相关，而在对照组中无显著相关性（阿司匹林组，比值比[OR]=1.086，95%CI=1.004-1.175，P=0.040；对照组，OR=1.060，95%CI=0.968-1.161，P=0.209）。
从妊娠 12 至 20 周开始，每天给予 100mg 阿司匹林直至 34 周妊娠，无论产妇特征如何，均不会增加潜在出血和 PPH 的风险。在阿司匹林组中，BMI 与 PPH 之间呈正相关，且具有统计学意义。
ClinicalTrials.gov，NCT01979627。
