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Maternal Obesity and Small for Gestational Age Infants

This study has been completed.
Sponsor:
Information provided by:
Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:
NCT00371657
First received: August 30, 2006
Last updated: January 31, 2008
Last verified: January 2008
  Purpose

The purpose of this retrospective pilot study is to address the effect that obesity, in the absence of other comorbidities, has on birth weight. We wish to determine if obesity is a risk factor for small for gestational age (SGA) or intrauterine growth restricted (IUGR) infants in our clinic population. There have been many studies linking maternal obesity with fetal macrosomia, defined as fetal birth weight greater than 4500 grams. However, we have noted that a percentage of our obese patient population has delivered either an SGA or IUGR infant. SGA refers to a constitutionally small infant weighing less than the 10th percentile for age. This refers to a genetically normal infant. IUGR refers to a fetus whose growth has been restricted by influences other than normal genetics.

Our study population will consist of all women over the age 18 who delivered a term infant either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July 1st 2004 and December 31st 2005.

The diagnosis of obesity will be based upon a Body Mass Index (weight in kilograms/height in meters squared) of thirty or greater. We will look at the infant birth weight as recorded in the patient's chart. We will define SGA or IUGR as birth weight less than the 10th percentile for gestational age as defined previously. The control group will consist of women meeting the same criteria except they will have a BMI less than thirty but greater than 19.8 as low maternal weight is also a risk factor for IUGR. We will compare the average birth weight and the rates of SGA/IUGR infants between the two groups and analyze using the chi-squared method of analysis.


Condition
Obesity
Small for Gestational Age

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Obesity as a Risk Factor for Small for Gestational Age and Intrauterine Growth Restriction Infants

Resource links provided by NLM:


Further study details as provided by Oklahoma State University Center for Health Sciences:

Estimated Enrollment: 420
Study Start Date: July 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Our study population will consist of all women over the age 18 who delivered a term infant either by vaginal delivery or cesarean section at Tulsa Regional Medical Center between July 1st 2004 and December 31st 2005. They must have had at least one visit at the Houston Park Ob-Gyn clinic, not including the initial prenatal lab visit, before delivery.

Exclusion Criteria:

  • We will exclude women with multiple gestation, hypothyroidism, hyperthyroidism, heart disease, tobacco or drug use, gestational or preexisting diabetes, autoimmune disease of any form, hypertension, collagen vascular disease, any disease process resulting in decreased gastrointestinal nutrient absorption, or lung disease as these are conditions known to be risk factors for IUGR.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00371657

Locations
United States, Oklahoma
Oklahoma State University Center for Health Sciences Houston Parke Clinic
Tulsa, Oklahoma, United States, 74127
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Kimberly A. Sorensen, D.O. Oklahoma State University Center for Health Sciences
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00371657     History of Changes
Other Study ID Numbers: 2006017
Study First Received: August 30, 2006
Last Updated: January 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:
obesity
small for gestation age
intrauterine growth restriction

Additional relevant MeSH terms:
Fetal Growth Retardation
Obesity
Body Weight
Fetal Diseases
Growth Disorders
Nutrition Disorders
Overnutrition
Overweight
Pathologic Processes
Pregnancy Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014