Obesity Clinical Trial
Official title:
Obesity as a Risk Factor for Small for Gestational Age and Intrauterine Growth Restriction Infants
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.
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. Obesity is defined as a body mass
index (BMI) greater than 30 by the World Health Organization and the National Institutes of
Health. This is a relevant topic in health care today as one-third of adult women fall into
the category of obese. As this number increases, we will be faced with the challenge to
provide comprehensive prenatal care to these women. Risk factors for IUGR in particular
include hypertension, renal disease, restrictive lung disease, diabetes, cyanotic heart
disease, antiphospholipid syndrome, collagen vascular disease, hemoglobinopathies, tobacco
and drug use, severe malnutrition, placental disease, multiple gestation, infection, genetic
disorders, and teratogenic exposure. The children born with this condition are at greater
risk for hypothermia, hypoglycemia, apneic episodes, seizures, sepsis, and neonatal death.
Long term problems usually develop based on the cause of the SGA or IUGR status with most
catching up growth-wise to other children their age. Previous studies have linked these
conditions to higher incidence of hypertension and cardiovascular problems. The most basic
screening for these conditions is the simple fundal height measurement, as the most likely
physical finding will be uterine size less than dates. It is questionable how accurate this
measurement is in the obese population as the measurement is taken over the layer of
abdominal fat. Obesity in the pregnant patient is linked to increased rates of hypertension,
preeclampsia, and gestational or preexisting diabetes. Although many studies have also
linked fetal macrosomia to maternal obesity, there have been studies published within the
last year that relate maternal obesity with SGA or IUGR infants. A Danish study looked at a
cohort of women who delivered singleton infants. They looked at pregnancy complications
including diabetes, hypertension, preeclampsia, and cesarean delivery. The study population
included only deliveries from 37-42 weeks gestation. Women with hypertension and preexisting
diabetes were included in the study population. The findings included higher risk of
macrosomic infants in the general study population. In a small segment of the study
population, however, they found increased incidence of SGA infants but not IUGR infants.
This hints at a possible relationship between obesity and SGA but does not control for other
variables. A study out of Medical University of South Carolina looked at prepregnancy
weights and subsequent weight gain. It was a cohort study using birth certificate
information linked to the South Carolina Pregnancy Risk Assessment Monitoring System, a
system of telephone and mail survey, to collect the data for this study. The results
included a 1.8 times greater likelihood of an obese woman delivering a very low birth weight
infant (3).
Study Population Inclusion/Exclusion 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. We choose
this time frame as we feel this will give an adequate sample size of approximately about 160
women in the study group and about 260 in the control group, while allowing for completion
of the project within 12 to 18 months. Our statistician, Dr. Mark Payton, has completed a
power analysis for these numbers, and it is included with our submission. We will define a
term infant as 37 weeks gestation or greater. They must have had at least one visit at the
Houston Park Ob-Gyn clinic, not including the initial prenatal lab visit, before delivery.
Our study population will consist of mainly Medicaid patients, most of who are of lower
socioeconomic status. The ethnic blend of our study population will include Caucasian,
African-American, Hispanic, American Indian, and Asian women. Our study population will have
a BMI greater than or equal to 30 based on initial recorded weight and recorded height. 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 (5).
Early Termination Criteria N/A
Methods/Procedures Diagnosis The diagnosis of obesity will be based upon initial weight and
height recorded in the patients chart, typically during the first trimester, to derive a BMI
(weight in kilograms/height in meters squared). Although total weight gain during a term
pregnancy could add enough to the BMI to falsely indicate obesity, since we will be using
the initial weight recorded, this difficulty should be minimized. The cutoff for our study
group will be a BMI of thirty or greater as this is the definition of obesity by the World
Health Organization and the National Institutes of Health. 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.
Data Collection The collaborating investigators and research assistants will collect only
the following information from the patients chart: age, height, weight at initial visit,
date of delivery, infant birth weight, smoking status, and any of the abovementioned
comorbidities that would exclude the patient from the study. No other data will be collected
from any patients chart. We will utilize research assistants in the collection of this data,
and these research assistants will be OSU medical students employed by the work study
program to work on this project. They will be collecting data from clinic records. They have
basic human research and HIPAA training and are allowed access to patient chart information
as they fall under the OSU community of individuals with this privilege. Analysis We will
compare the average birth weight and the rates of SGA/IUGR infants between the two groups.
We will analyze the results using chi-squared method of analysis.
Confidentiality The clinic records to be reviewed will be kept in the Houston Park medical
records department which is either locked or under security supervision at all times. The
hospital records will be kept in the Tulsa Regional Medical Center health information
management department. This department is locked 24 hours a day. No identifying information
from any individual's chart will be recorded, so de-identification will occur when the data
is collected, and no master list of patient names or other identifying information will be
kept.
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Time Perspective: Retrospective
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