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Completed

NCT Number: NCT01935076

miRNA in Fetal Overgrowth

The purpose of this study is to determine whether placental and umbilical cord blood miRNA expression is altered in women with obesity with macrosomic neonates to when compared to miRNA expression from control patients.

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Key information

Conditions

Obesity Body Weight Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neonatal exposure to maternal obesity

Behavioral

Primary outcomes

  1. Fetal Overgrowth

    Time frame: Delivery date to up to 6 weeks post partum

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Placental miRNA (microRNA) Profile in Fetal Overgrowth Related to Maternal Obesity Study

Acronym: MIFO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2013
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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