NCT00371657

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 4, 2008

Status Verified

January 1, 2008

Enrollment Period

4 months

First QC Date

August 30, 2006

Last Update Submit

January 31, 2008

Conditions

Keywords

obesitysmall for gestation ageintrauterine growth restriction

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

ObesityFetal Growth Retardation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic Processes

Study Officials

  • Kimberly A. Sorensen, D.O.

    Oklahoma State University Center for Health Sciences

    PRINCIPAL INVESTIGATOR

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

Locations