Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 26, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2006

Completed
Last Updated

July 2, 2017

Status Verified

September 22, 2006

First QC Date

June 23, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

EpidemiologyPopulationPregnancyPreeclampsia

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Boggess KA, Lieff S, Murtha AP, Moss K, Beck J, Offenbacher S. Maternal periodontal disease is associated with an increased risk for preeclampsia. Obstet Gynecol. 2003 Feb;101(2):227-31. doi: 10.1016/s0029-7844(02)02314-1.

    PMID: 12576243BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 26, 2006

Study Start

January 31, 2005

Study Completion

September 22, 2006

Last Updated

July 2, 2017

Record last verified: 2006-09-22

Locations