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NCT00371657 · ClinicalTrials.gov registry record

Maternal Obesity and Small for Gestational Age Infants

A clinical trial, sponsored by Oklahoma State University Center for Health Sciences.

Completed
Registry status
420
Enrollment target

NCT00371657: Completed study, sponsored by Oklahoma State University Center for Health Sciences.

NCT00371657 is a clinical trial that has completed, run by Oklahoma State University Center for Health Sciences. The registered enrollment target is 420 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00371657 has completed, sponsored by Oklahoma State University Center for Health Sciences.

COMPLETED
Registry status
420 participants
Enrollment target

Study 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 Details

FieldValue
Enrollment Target 420 participants
Start Date 2006-07
Est. Completion 2006-11

What the finished NCT00371657 record still lists

NCT00371657 is an observational study that tracks outcomes without assigning an intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00371657 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00371657 about?

NCT00371657 is a clinical study titled "Maternal Obesity and Small for Gestational Age 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 populat...

What is the current status of trial NCT00371657?

This trial is currently completed. The enrollment target is 420 participants. The study started on 2006-07. Estimated completion is 2006-11.

Who is sponsoring clinical trial NCT00371657?

This trial is sponsored by Oklahoma State University Center for Health Sciences, which has 24 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00371657, the US trial registry maintained by the National Library of Medicine. NCT00371657 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.