Antenatal Testing in Obese Woman, is it Really Necessary? — ATOWS  

Obesity in Pregnancy Clinical Trial

Official title: Antenatal Testing in Obese Woman, is it Really Necessary?

Status Not yet recruiting

Clinical Trial Summary

It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).

Clinical Trial Description

1. Purpose: To determine if antenatal testing improves outcomes in obese pregnant women

2. Rationale: It has been well established that obese pregnant women are at increase risk of stillbirth compared to matched non obese controls. This relative risk is increased not only with increasing gestational age in obese women but with increasing severity of obesity. The increased risk of stillbirth has led some obstetricians to begin antenatal testing in obese women; however, there is little evidence that antenatal fetal surveillance improves outcomes.

3. Study/Project Population: Pregnant women before 32 weeks of gestation with an initial BMI >30kg/m2

4. Research Design: Randomized Controlled Trial

5. Study/Project Procedures: Patients will be randomized to one of three groups: daily kick counts only, nonstress test, amniotic fluid index, and daily kick counts, and biophysical profile and daily kick counts. These patients will be randomly assigned a group in a 1:1:1 ratio using a random number generator available online. Patients assigned to the daily kick counts only group will be called weekly to ensure they are doing daily kick counts. If they are noncompliant, they will be removed from the study and will undergo nonstress tests if they meet the initial BMI criteria as is the standard practice at our institution.

6. Outcomes Measured: Stillbirth, induction of labor, mode of delivery, neonatal intensive care unit admission, AGPARs <7 at 5 minutes of life ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity in Pregnancy

• NCT number: NCT02821988
• Study type: Interventional
• Source: University of Tennessee Health Science Center
• Contact: Laura Grese, MD
• Phone: 4235712990
• Email: lgrese@uthsc.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2016
• Completion date: May 2017