- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01935076
miRNA in Fetal Overgrowth (MIFO)
Placental miRNA (microRNA) Profile in Fetal Overgrowth Related to Maternal Obesity Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MicroRNA's are a class of non-coding RNA's that function as translational repressors and are thought to modulate tissue development, proliferation, differentiation and function. Differential expression of certain placental miRNA's has been associated with preeclampsia.
The fetal origins of adult disease hypothesis suggests that risk factors from intrauterine environmental exposures affect the fetus' development during sensitive periods, and increases the risk of specific diseases in adult life. Our aim is to understand factors that predispose fetuses to fetal overgrowth in utero, especially in women with obesity. The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.
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:
- singleton pregnancy
- prenatal care & delivery at the Hospital of the University of Pennsylvania system
- Normal glucose tolerance test results (less than 120 mg/dl)
Exclusion Criteria:
- Multiple gestation
- under 18 years old, or over 45 years old
- chronic hypertension
- preeclampsia
- chronic steroid use
- diabetes
- major fetal anomaly
- connective tissue disorder requiring medication
- active HIV
- Hepatitis C
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Obese mother/ Macrosomic baby
Obese mother that delivers a macrosomic neonate to understand the effects neonatal exposure to maternal obesity.
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Obese mother/ normal weight baby
Obese mother that delivers a normal weight neonate to understand effects neonatal exposure to maternal obesity.
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Normal weight mother/ Macrosomic baby
Normal weight mother that delivers a macrosomic neonate
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Normal weight mother/ Normal weight baby
Normal weight mother who delivered a normal weight neonate
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fetal Overgrowth
Tidsramme: Delivery date to up to 6 weeks post partum
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Placental and cord blood samples will be studied for miRNA expression.
The objective of the study is to identify miRNA which are differentially expressed in the placenta and cord blood of pregnancies that are affected by fetal macrosomia to determine factors that may predispose fetuses to fetal overgrowth.
|
Delivery date to up to 6 weeks post partum
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Celeste P Durnwald, 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
- 817124
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