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Family Study on Preeclampsia

A Familial Genetic Study on Preeclampsia: A Pilot Study

This study will examine a possible genetic basis for preeclampsia, a disorder of high blood pressure and protein in the urine during pregnancy. Preeclampsia is a major pregnancy complication affecting both mother and baby. Previous research has shown that preeclampsia tends to run in certain families. This study will determine which genes may be involved in preeclampsia.

Women who have had preeclampsia (called the index woman) may be eligible for this study. They will be recruited through the Preeclampsia Foundation. In addition, the following relatives of the index woman may be enrolled:

  • The child from the preeclampsic pregnancy
  • The index woman's biological parents
  • The index woman's siblings who have given birth or fathered a child and their family members

The study will exclude any index women or family members who have had chronic hypertension, diabetes, polycystic ovary syndrome, or whose pregnancy that involved preeclampsia was a multiple fetus pregnancy or that was conceived through use of fertility technology.

All women participants fill out a questionnaire to collect demographic data (e.g., age, race, marital status, etc.) and information on their medical and reproductive history, use of tobacco and medicines, and other factors that may be associated with preeclampsia syndrome. Women who have had preeclampsia or hypertension in pregnancy are asked to sign a medical record release form for study investigators to obtain a copy of the medical record for that pregnancy. All male and female participants provide a mouthwash rinse sample for extraction of DNA for gene studies. For babies too young to rinse with mouthwash, a soft brush is used to brush the inside of the mouth to collect cheek cells.

Mouthwash samples are analyzed for genes that may be associated with preeclampsia.

研究概览

地位

完全的

条件

详细说明

Preeclampsia is a syndrome of hypertension accompanied by proteinuria. It is a major pregnancy complication, associated with premature delivery, fetal growth restriction, abruptio placentae, and fetal death, as well as maternal morbidity and mortality. Although preeclampsia has been recognized for centuries, the etiology of this disorder remains unknown. Familial clustering of preeclampsia has long been identified, leading to the concept of a genetic basis for this syndrome. We propose a familial genetic study of preeclampsia. As such a study is often difficult to do, we plan to conduct a pilot study to test the feasibility, logistics and examine frequency of genetic polymorphism of certain genes in the target population.

A total of 50 women who had preeclampsia during their first pregnancy will be identified through the Preeclampsia Foundation. Women who had chronic hypertension or diabetes prior to the first pregnancy will be excluded. We also will try to enroll their family members to this study. All subjects will be asked to complete a self-administered questionnaire and collect mouth wash samples. Women who reported having hypertension during pregnancy will be asked to sign a medical record release form. A copy of the medical record will be obtained to confirm the diagnosis of preeclampsia. DNA will be extracted from buccal cells. Frequency of polymorphisms for a number of candidate genes (e.g., HLA-G, AGT, eNOS, MTHFR, IL-1 beta, TNF-alpha, Prothrombin, and Factor V Leiden) will be examined. Information and experience gained from this pilot study will be most valuable for use to plan a main study.

研究类型

观察性的

注册

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institute of Child Health and Human Development (NICHD)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

Women who have had documented severe preeclampsia or eclampsia in their first pregnancy in the past 10 years will be potentially eligible for this study.

Through the index woman, we will invite her biological parents, siblings who have given birth or fathered a child and their family members to participate in this study.

EXCLUSION CRITERIA:

Excluded will be those who had chronic hypertension, diabetes, polycystic ovary syndrome, or the index pregnancy was a multifetal gestation or conceived by assisted reproductive technology.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年1月31日

研究完成

2006年9月22日

研究注册日期

首次提交

2006年6月23日

首先提交符合 QC 标准的

2006年6月23日

首次发布 (估计)

2006年6月26日

研究记录更新

最后更新发布 (实际的)

2017年7月2日

上次提交的符合 QC 标准的更新

2017年6月30日

最后验证

2006年9月22日

更多信息

与本研究相关的术语

其他研究编号

  • 999905097
  • 05-CH-N097

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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