Obesity in Pregnancy
Conditions
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
Interventions
DEVICEExternal fetal monitor for Nonstress test
DEVICEUltrasonography for Biophysical profile
Sponsors
Regional One Health
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stillbirth | until delivery, up to 41 weeks | demise of infant prior to delivery as verified by ultrasonography |
| Mode of delivery | at delivery, up to 41 weeks | whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal intensive care unit admission admission | at delivery, up to 41 weeks |
| Apgar score of less than 7 at 5 minutes | at delivery, up to 41 weeks |
Contacts
Primary ContactLaura Grese, MD
Backup ContactLuis Gomez, MD
Outcome results
None listed