Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes

Columbia University

Status: Terminated

Conditions: Obesity Complicating Childbirth

Treatments: Other: Ultrasound Examination; Other: Antenatal Testing (biophysical profile)

Study type: Interventional

Funder types: Other

Identifiers

NCT04180566

AAAS5275

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Weekly antenatal testing

Other group

Description:

Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive weekly antenatal testing (biophysical profile) starting at 34 weeks as well as growth ultrasound every 4 weeks.

Treatment:

Other: Antenatal Testing (biophysical profile)

Growth ultrasound examination every 4 weeks

Other group

Description:

Women with BMI 30-40 between 20 and 34.6 weeks of gestation will receive ultrasound examination (growth ultrasound) every 4 weeks starting at 34 weeks.

Treatment:

Other: Ultrasound Examination