miRNA in Fetal Overgrowth (MIFO)

May 23, 2014 updated by: Celeste Durnwald, University of Pennsylvania

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All patients delivering in the labor and delivery unit at the Hospital of the University of Pennsylvania.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese mother/ Macrosomic baby
Obese mother that delivers a macrosomic neonate to understand the effects neonatal exposure to maternal obesity.
Behavioral: Neonatal exposure to maternal obesity
Obese mother/ normal weight baby
Obese mother that delivers a normal weight neonate to understand effects neonatal exposure to maternal obesity.
Behavioral: Neonatal exposure to maternal obesity
Normal weight mother/ Macrosomic baby
Normal weight mother that delivers a macrosomic neonate
Normal weight mother/ Normal weight baby
Normal weight mother who delivered a normal weight neonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Delivery date to up to 6 weeks post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Celeste P Durnwald, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 19, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 23, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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