Family Study on Preeclampsia

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00344162
First received: June 23, 2006
Last updated: March 5, 2008
Last verified: September 2006
  Purpose

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.


Condition
Preeclampsia

Study Type: Observational
Official Title: A Familial Genetic Study on Preeclampsia: A Pilot Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: January 2005
Estimated Study Completion Date: September 2006
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344162

Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00344162     History of Changes
Other Study ID Numbers: 999905097, 05-CH-N097
Study First Received: June 23, 2006
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Epidemiology
Population
Pregnancy
Preeclampsia

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 29, 2014