Pregnancy ComplicationsNCT00194142
Cytomegalovirus (CMV) Infection in Amniotic Fluid
An observational study of Pregnancy Complications and Cytomegalovirus Infections, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Pregnancy Complications, Cytomegalovirus Infections
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2008
- 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 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The purpose of this study is to determine the prevalence of Cytomegalovirus (CMV) infection in amniotic fluid specimens obtained at 16 to 18 weeks of pregnancy and to determine if CMV infection of amniotic fluid supernatant and/or amniocytes is associated with adverse obstetric outcomes. Amniotic fluid will be obtained from an already established registry. and analyzed in conjunction with a chart review under a HIPAA Waiver of Authorization.
Who may be able to join
- Women who deliver at term without pregnancy complications
- Women who deliver (preterm, less than 37 weeks of gestation) as a result of spontaneous preterm labor
- Women whose pregnancies are complicated by severe preeclampsia
Who cannot join
- Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality
- Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.
Read the detailed description
CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. Unlike infection in adults, congenital infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood.
The incidence of CMV detection in amniotic fluid collected in the second trimester is thought to be low. However, the association between detection of CMV infection in the second trimester and ultimate pregnancy outcome is poorly described.
In this study, we plan to determine if CMV detection in amniotic fluid collected in the second trimester is associated with pregnancy complications.
- Keywords
- Pregnancy, Cytomegalovirus
- Medical subject headings
- Pregnancy Complications, Cytomegalovirus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doris Chou, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194142
- Sponsor's protocol ID
- 803583
- Other IDs
- R01 17625-03-14
- Status last verified
- Aug 2016
- First submitted
- 12 Sep 2005
- Last updated
- 17 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus (CMV) Infection in Amniotic Fluid
- ClinicalTrials.gov ID
- NCT00194142
- Acronym / sponsor ID
- 803583
- Keywords
- Pregnancy, Cytomegalovirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 19 Sep 2005 (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.
The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.
Detailed description
CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. Unlike infection in adults, congenital infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood.
The incidence of CMV detection in amniotic fluid collected in the second trimester is thought to be low. However, the association between detection of CMV infection in the second trimester and ultimate pregnancy outcome is poorly described.
In this study, we plan to determine if CMV detection in amniotic fluid collected in the second trimester is associated with pregnancy complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The purpose of this study is to determine the prevalence of Cytomegalovirus (CMV) infection in amniotic fluid specimens obtained at 16 to 18 weeks of pregnancy and to determine if CMV infection of amniotic fluid supernatant and/or amniocytes is associated with adverse obstetric outcomes. Amniotic fluid will be obtained from an already established registry. and analyzed in conjunction with a chart review under a HIPAA Waiver of Authorization.
Key inclusion criteria (3 listed)
- Women who deliver at term without pregnancy complications
- Women who deliver (preterm, less than 37 weeks of gestation) as a result of spontaneous preterm labor
- Women whose pregnancies are complicated by severe preeclampsia
Key exclusion criteria (2 listed)
- Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality
- Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease
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 17 Aug 2016.
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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.
Doris Chou, MD principal investigator
University of Pennsylvania
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 Pregnancy Complications and Cytomegalovirus Infections, run by University of Pennsylvania 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 3 inclusion and 2 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 17 Aug 2016. 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?
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 17 Aug 2016.