- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00194155
Cytomegalovirus (CMV) Infection in Pregnancy
Cytomegalovirus Infection and Pregnancy Outcomes
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Samuel Parry, MD, University of Pennsylvania
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01 17625-03-13
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Kliniske forsøg med Graviditetskomplikationer
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