miRNA in Fetal Overgrowth

NCT ID: NCT01935076

Last Updated: 2014-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese mother/ Macrosomic baby

Obese mother that delivers a macrosomic neonate to understand the effects neonatal exposure to maternal obesity.

Neonatal exposure to maternal obesity

Intervention Type BEHAVIORAL

Obese mother/ normal weight baby

Obese mother that delivers a normal weight neonate to understand effects neonatal exposure to maternal obesity.

Neonatal exposure to maternal obesity

Intervention Type BEHAVIORAL

Normal weight mother/ Macrosomic baby

Normal weight mother that delivers a macrosomic neonate

No interventions assigned to this group

Normal weight mother/ Normal weight baby

Normal weight mother who delivered a normal weight neonate

No interventions assigned to this group

Interventions

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Neonatal exposure to maternal obesity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Celeste Durnwald

Assistant Professor, Maternal Fetal Medicine, Department of Obstetrics and Gynecology Director, Penn Perinatal Diabetes Program Director, High Risk Clinic at the Helen O. Dickens Center for Women's Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celeste P Durnwald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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817124

Identifier Type: -

Identifier Source: org_study_id

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