Cytomegalovirus (CMV) Infection in Pregnancy

Cytomegalovirus Infection and Pregnancy Outcomes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00194155

Enrollment

283

Registered

2005-09-19

Start date

2003-05-31

Completion date

2008-02-29

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infection, Pregnancy Complications

Keywords

cytomegalovirus, pregnancy, placenta

Brief summary

The purpose of this study is to determine if (recurrent) cytomegalovirus (CMV) infection of the mother results in pregnancy complications such as preterm delivery, severe preeclampsia, poor fetal growth, or stillbirth.

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, fetal 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. In this study, we plan to determine if CMV recurrence in the mother results in pregnancy complications. The pregnancy complications listed above have been associated with poor placental function. We also plan to determine if (recurrent) CMV infection in the mother is associated with CMV infection of the placenta.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

FEMALE

Age

15 Weeks to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women who deliver at term without pregnancy complications * Women who deliver (preterm, less than 37 weeks gestation) as a result of spontaneous preterm labor * Women whose pregnancies are complicated by severe preeclampsia * Women whose pregnancies are complicated by unexplained poor fetal growth (less than the 10th percentile). * Women whose pregnancies are complicated by unexplained stillbirth.

Exclusion criteria

* 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

Countries

United States

Outcome results