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临床试验/NCT03073434
NCT03073434Unknown不适用

Pregnancy Outcomes in Renal Transplant Recipients

Unity Health Toronto0 个研究点目标入组 17 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
17
主要终点
Maternal health outcomes obtained from patient medical record

研究概览

简要总结

This is a retrospective study involving all patients with a history of renal transplant that attended antenatal clinics at various Toronto hospitals and subsequently delivered between January 2000 and December 2014.

The purpose of this study is to describe the incidence of adverse pregnancy-and transplant-related outcomes, and report placental ultrasound and placental pathology findings in renal transplant recipients with contemporary standards of care in Toronto.

This study also seeks to determine whether factors such as maternal age, transplant-to-pregnancy interval, hypertension, diabetes mellitus, treatment regimens, and the primary cause for renal failure are associated with higher risk of adverse pregnancy outcomes in renal transplant recipients.

详细描述

Adverse pregnancy outcomes in women with renal transplants have been attributed to a number of factors. A recent systematic review suggested an association between maternal age and adverse pregnancy outcomes such as miscarriage and stillbirth. There are also some data to suggest that maternal hypertension, diabetes mellitus, elevated serum creatinine and proteinuria and some medications such as cyclosporine are associated with adverse pregnancy outcomes such as preeclampsia, intrauterine growth restriction and preterm delivery.There is no consensus on whether the transplant-to-pregnancy interval is associated with adverse pregnancy outcomes. As well, it is not clear if the findings of other studies will also hold true in a Toronto population.

This study seeks to answer the following questions:

  1. What is the incidence of adverse transplant- and pregnancy-related adverse outcomes in renal transplant recipients that have had pregnancies between 2000 and 2014 in Toronto and how does this compare with earlier data from Toronto and with recently published data?
  2. Are factors such as maternal age, transplant-to-pregnancy interval, hypertension, diabetes mellitus, specific treatment regimens and the primary cause for renal failure associated with an increased risk of adverse pregnancy- and transplant-related adverse outcomes in these women?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All patients with a history of renal transplant that attended antenatal clinics at Mt. Sinai Hospital, Sunnybrook Health Sciences Centre and St. Michael's hospital and subsequently delivered between January 2000 and December 2014

排除标准

  • Patients who do not meet the above criteria are excluded from the sample

结局指标

主要结局

Maternal health outcomes obtained from patient medical record

时间窗: From start of pregnancy (1 week gestation) to 6 weeks post-partum

Observed health outcomes of the mother after giving birth, obtained retrospectively from the patient's medical record.

Fetal and neo-natal health outcomes obtained from patient medical record

时间窗: From start of pregnancy (1 week gestation) to 6 weeks post-partum

Observed health outcomes of the fetus/neonate after delivery, obtained retrospectively from the patient's medical record.

Transplant-related outcomes obtained from patient medical record

时间窗: From start of pregnancy (1 week gestation) to 6 weeks post-partum

Graft function during pregnancy and at end of pregnancy, obtained retrospectively from the patient's medical record.

Placental outcomes obtained from patient medical record

时间窗: Measured immediately after delivery

Biochemistry and physical characteristics of the placenta, obtained retrospectively from the patient's medical record.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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