Antenatal Testing in Obese Woman, is it Really Necessary?

Obesity in Pregnancy Clinical Trial

— ATOWS  

Official title:

Antenatal Testing in Obese Woman, is it Really Necessary?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02821988
• Other study ID #: 16-04574-XP
• Status: Not yet recruiting
• Phase: N/A
• First received: June 24, 2016
• Last updated: June 29, 2016
• Start date: July 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2016
• Source: University of Tennessee Health Science Center
• Contact: Laura Grese, MD
• Phone: 4235712990
• Email: lgrese[@]uthsc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

less then 32 weeks gestation BMI > 30kg/m2 English speaking

Exclusion Criteria:

age < 18 age >45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age >32 weeks

Study Design

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

Related Conditions & MeSH terms

• Obesity in Pregnancy

Intervention

Device:
• External fetal monitor for Nonstress test

• Ultrasonography for Biophysical profile

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee Health Science Center	Regional One Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stillbirth	demise of infant prior to delivery as verified by ultrasonography	until delivery, up to 41 weeks	No
Primary	Mode of delivery	whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded	at delivery, up to 41 weeks	No
Secondary	Neonatal intensive care unit admission admission		at delivery, up to 41 weeks	No
Secondary	Apgar score of less than 7 at 5 minutes		at delivery, up to 41 weeks	No