Maternal Obesity and Small for Gestational Age Infants
Obesity as a Risk Factor for Small for Gestational Age and Intrauterine Growth Restriction Infants
1 other identifier
observational
420
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2006
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 30, 2006
CompletedFirst Posted
Study publicly available on registry
September 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFebruary 4, 2008
January 1, 2008
4 months
August 30, 2006
January 31, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oklahoma State University Center for Health Sciences Houston Parke Clinic
Tulsa, Oklahoma, 74127, United States
Related Publications (1)
Hulsey TC, Neal D, Bondo SC, Hulsey T, Newman R. Maternal prepregnant body mass index and weight gain related to low birth weight in South Carolina. South Med J. 2005 Apr;98(4):411-5. doi: 10.1097/01.SMJ.0000145283.69631.FC.
PMID: 15898514BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly A. Sorensen, D.O.
Oklahoma State University Center for Health Sciences
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 30, 2006
First Posted
September 4, 2006
Study Start
July 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 4, 2008
Record last verified: 2008-01