PreeclampsiaNCT00344162
Family Study on Preeclampsia
An observational study of Preeclampsia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2005to 22 Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Preeclampsia
- Keywords
- Epidemiology, Population, Pregnancy, Preeclampsia
- Medical subject headings
- Pre-Eclampsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study start31 Jan 2005
- Study completion22 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344162
- Sponsor's protocol ID
- 999905097
- Other IDs
- 05-CH-N097
- Status last verified
- 22 Sep 2006
- First submitted
- 23 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 12576243
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Familial Genetic Study on Preeclampsia: A Pilot Study
- ClinicalTrials.gov ID
- NCT00344162
- Acronym / sponsor ID
- 999905097
- Conditions
- Preeclampsia
- Keywords
- Epidemiology, Population, Pregnancy, Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 31 Jan 2005
- Study completion
- 22 Sep 2006
- First posted
- 26 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12576243Boggess 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.
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Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.