Clinical trial NCT02821988: Antenatal Testing in Obese Woman, is it Really Necessary?
Official title: Antenatal Testing in Obese Woman, is it Really Necessary?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity in Pregnancy
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Regional One Health
First posted: 2016-07-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Stillbirth
timeFrame: until delivery, up to 41 weeks
measure: Mode of delivery
timeFrame: at delivery, up to 41 weeks
Secondary outcomes:
measure: Neonatal intensive care unit admission admission
timeFrame: at delivery, up to 41 weeks
measure: Apgar score of less than 7 at 5 minutes
timeFrame: at delivery, up to 41 weeks
Other outcomes:
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Study officials:
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