Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Columbia University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Average gestational age at delivery of participating women's babies
Overview
Brief Summary
The purpose of study is to evaluate whether weekly antenatal testing in pregnant women with body mass index (BMI) 30-40 in the third trimester is associated with earlier delivery when compared to growth ultrasounds every 4 weeks. The investigators will also assess the differences in maternal and neonatal outcomes between the groups.
Detailed Description
Over the last decade, the prevalence of obesity has dramatically increased in women in reproductive age. It is well known that obesity has been associated with increased risk of antenatal complications, maternal and perinatal morbidity, including higher risk of stillbirth. Studies including obese women without other antepartum comorbidities have shown that up to 11% of pregnancies are complicated with fluid and fetal growth abnormalities. According to American College of Obstetricians and Gynecologists (ACOG) guidelines, antepartum surveillance has not been proven to improve pregnancy outcomes in such cases and no specific recommendations for antepartum surveillance in obese women have been established.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women at or over 18 years of age
- •Singleton pregnancy with no major fetal anomalies
- •Pregnancies and gestational age will be well dated
- •Obese with BMI 30-40kg/m2
Exclusion Criteria
- •Women with any complications at time of randomization that would require antenatal testing in the third trimester as per ACOG guidelines including: hypertension, systemic lupus erythematosus, chronic renal disease, antiphospholipid syndromes, hyperthyroidism poorly controlled, hemoglobinopathies, cyanotic heart disease, gestational hypertension, pre-eclampsia, gestational diabetes medication controlled, oligohydramnios, intrauterine growth restriction before randomization, isoimmunization, history of fetal demise
- •Women with indication for weekly testing as per local protocol
Outcomes
Primary Outcomes
Average gestational age at delivery of participating women's babies
Time Frame: At time of delivery
This is to measure the number of weeks that the baby has been in the uterus. It is measured from the first day of the woman's last menstrual cycle to the date of delivery. A normal pregnancy can range from 38 to 42 weeks. A significant delay in gestational age of delivery would be \> 7 days out of this range.
Secondary Outcomes
- Number of participating women who experienced composite maternal morbidity(At time of delivery)
- Average birth weight of participating women's babies(At time of delivery)
- Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth(At time of delivery)
- Number of participating women whose babies experienced composite neonatal morbidity(At time of delivery)