miRNA in Fetal Overgrowth

Completed

• Conditions: Obesity
• Interventions: Behavioral: Neonatal exposure to maternal obesity

• Registration Number: NCT01935076
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese mother/ Macrosomic baby	Neonatal exposure to maternal obesity	Obese mother that delivers a macrosomic neonate to understand the effects neonatal exposure to maternal obesity.
Obese mother/ normal weight baby	Neonatal exposure to maternal obesity	Obese mother that delivers a normal weight neonate to understand effects neonatal exposure to maternal obesity.

Primary Outcome Measures

Name	Time	Method
Fetal Overgrowth	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.

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States