活体肾脏捐赠者的妊娠结局:加拿大三省基于人口的队列研究协议》。

IF 1.6 Q3 UROLOGY & NEPHROLOGY
Canadian Journal of Kidney Health and Disease Pub Date : 2024-10-06 eCollection Date: 2024-01-01 DOI:10.1177/20543581241284030
Carol Wang, Kyla L Naylor, Eric McArthur, Jessica M Sontrop, Pavel Roshanov, Ngan N Lam, Sarah D McDonald, Krista L Lentine, James King, Erik Youngson, Joseph Beyene, Elizabeth Hendren, Amit X Garg
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引用次数: 0

摘要

背景:活体肾脏捐献者中有很大一部分是育龄妇女。之前的一些研究报告显示,与非活体捐肾者相比,活体捐肾者患妊娠高血压和先兆子痫的风险较高。为了更好地量化活体肾脏捐献对产妇、胎儿/婴儿和新生儿造成不良后果的风险,还需要进一步的研究:目的:确定活体肾脏捐献者与基线健康状况相似的匹配非活体肾脏捐献者相比,妊娠期高血压、先兆子痫和子痫等妊娠期高血压疾病的风险,以及其他孕产妇和胎儿/婴幼儿结局的风险:设计与环境:利用加拿大行政医疗保健数据库开展基于人群的配对队列研究。该方案将在安大略省、阿尔伯塔省和不列颠哥伦比亚省三个省分别进行,研究结果将采用荟萃分析法进行统计合并:队列将包括在 1992 年 7 月至 2022 年 3 月期间捐献肾脏的 18 至 48 岁女性,以及在 1993 年 1 月至 2023 年 2 月期间至少有一次妊娠≥20 周的捐肾后单胎妊娠。我们预计安大略省至少有 150 名活体肾脏捐献者和 200 多名捐献后怀孕者,阿尔伯塔省和不列颠哥伦比亚省也有类似数量的捐献者和怀孕者。非捐献者将包括在 1993 年 1 月至 2023 年 2 月期间至少有一次妊娠≥20 周的普通人群中的女性。将根据捐献者肾切除术日期的分布情况,随机分配非妊娠期妇女的入组日期。新生儿样本将仅限于在其队列进入日期时年龄在 18 至 48 岁之间、分娩日期至少在其指定进入日期之后 6 个月的新生儿。对捐献者和非捐献者进行比较的一个顾虑是,捐献者比一般人群更健康。为了减少这种顾虑,我们还将采用 30 岁以上的排除标准来进一步限制非孤儿群体,使他们在队列进入时拥有与捐献者相似的健康指标。然后,捐献者孕妇和非捐献者孕妇将就以下 5 个潜在的混杂因素进行匹配(1:4):分娩日期、分娩日期时的产妇年龄、队列进入与分娩日期之间的时间、社区收入五分位数以及分娩日期时的胎次:主要结果是产妇妊娠高血压、子痫前期或子痫的综合结果。次要产妇结局将包括主要结局的组成部分、早期子痫前期、严重产妇发病率、剖宫产、产后出血和妊娠糖尿病。胎儿/婴儿/新生儿结局将包括早产/出生体重不足、胎龄小、新生儿重症监护室入院、死胎和新生儿死亡:分析的主要单位是妊娠。我们将使用随机效应对数二项式混合回归模型计算供体与非供体的主要综合结果风险比,以考虑多胎妊娠妇女之间以及供体与非供体配对组之间的相关性。我们将在每个省内进行统计分析,然后使用元分析技术合并汇总结果,得出研究结果的总体估计值:限制因素:由于相关法规禁止将个人层面的记录发送到其他省份,因此我们无法汇集所有 3 个省份的个人层面数据:与之前的研究相比,本研究能更好地估算出孕产妇、胎儿/婴儿和新生儿不良结局的捐赠可归因风险。移植中心可以利用研究结果为育龄女性活体捐献者提供咨询,并为怀孕的活体肾脏捐献者的随访和护理提供建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pregnancy Outcomes in Living Kidney Donors: Protocol of a Population-Based Cohort Study in Three Canadian Provinces.

Background: A substantial proportion of living kidney donors are women of childbearing age. Some prior studies report a higher risk of gestational hypertension and pre-eclampsia in living kidney donors compared with nondonors. Further research is needed to better quantify the risk of adverse maternal, fetal/infant, and neonatal outcomes attributable to living kidney donation.

Objective: To determine the risk of hypertensive disorders of pregnancy, including gestational hypertension, pre-eclampsia, and eclampsia, and other maternal and fetal/infant outcomes in living kidney donors compared with a matched group of nondonors of similar baseline health.

Design and setting: Protocol for a population-based, matched cohort study using Canadian administrative health care databases. The protocol will be run separately in 3 provinces, Ontario, Alberta, and British Columbia, and results will be combined statistically using meta-analysis.

Participants: The cohort will include women aged 18 to 48 years who donated a kidney between July 1992 and March 2022 and had at least one postdonation singleton pregnancy of ≥20 weeks gestation between January 1993 and February 2023. We expect to include at least 150 living kidney donors with over 200 postdonation pregnancies from Ontario and a similar number of donors and pregnancies across Alberta and British Columbia combined. Nondonors will include women from the general population with at least one pregnancy of ≥20 weeks gestation between January 1993 and February 2023. Nondonors will be randomly assigned cohort entry dates based on the distribution of nephrectomy dates in donors. The sample of nondonors will be restricted to those aged 18 to 48 years on their cohort entry dates with delivery dates at least 6 months after their assigned entry dates. A concern with donor and nondonor comparisons is that donors are healthier than the general population. To reduce this concern, we will also apply 30+ exclusion criteria to further restrict the nondonor group so that they have similar health measures at cohort entry as the donors. Donor and nondonor pregnancies will then be matched (1:4) on 5 potential confounders: delivery date, maternal age at delivery date, time between cohort entry and delivery date, neighborhood income quintile, and parity at delivery date.

Measurements: The primary outcome will be a composite of maternal gestational hypertension, preeclampsia, or eclampsia. Secondary maternal outcomes will include components of the primary outcome, early pre-eclampsia, severe maternal morbidity, cesarean section, postpartum hemorrhage, and gestational diabetes. Fetal/infant/neonatal outcomes will include premature birth/low birth weight, small for gestational age, neonatal intensive care unit admission, stillbirth, and neonatal death.

Methods: The primary unit of analysis will be the pregnancy. We will compute the risk ratio of the primary composite outcome in donors versus nondonors using a log-binomial mixed regression model with random effects to account for the correlation within women with multiple pregnancies and within matched sets of donors and nondonors. We will perform the statistical analyses within each province and then combine aggregated results using meta-analytic techniques to produce overall estimates of the study outcomes.

Limitations: Due to regulations that prevent individual-level records from being sent to other provinces, we cannot pool individual-level data from all 3 provinces.

Conclusion: Compared to prior studies, this study will better estimate the donation-attributable risk of adverse maternal, fetal/infant, and neonatal outcomes. Transplant centers can use the results to counsel female living donor candidates of childbearing age and to inform recommended practices for the follow-up and care of living kidney donors who become pregnant.

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来源期刊
CiteScore
3.00
自引率
5.90%
发文量
84
审稿时长
12 weeks
期刊介绍: Canadian Journal of Kidney Health and Disease, the official journal of the Canadian Society of Nephrology, is an open access, peer-reviewed online journal that encourages high quality submissions focused on clinical, translational and health services delivery research in the field of chronic kidney disease, dialysis, kidney transplantation and organ donation. Our mandate is to promote and advocate for kidney health as it impacts national and international communities. Basic science, translational studies and clinical studies will be peer reviewed and processed by an Editorial Board comprised of geographically diverse Canadian and international nephrologists, internists and allied health professionals; this Editorial Board is mandated to ensure highest quality publications.
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