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

NCT ID: NCT04180566

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-04
• Study Completion Date: 2021-03-10

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.

Conditions

Obesity Complicating Childbirth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Weekly antenatal testing

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.

Group Type: OTHER

Antenatal Testing (biophysical profile)

Intervention Type: OTHER

Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby).

Growth ultrasound examination every 4 weeks

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.

Group Type: OTHER

Ultrasound Examination

Intervention Type: OTHER

Includes a regular growth ultrasound examination.

Interventions

Ultrasound Examination

Includes a regular growth ultrasound examination.

Intervention Type: OTHER

Antenatal Testing (biophysical profile)

Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Gyamfi-Bannerman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Professor of Obstetrics/Gyn, Columbia University

Maria Andrikopoulou, MD, PhD

Role: STUDY_CHAIR

Postdoctoral Clinical Fellow in the Department of Obstetrics

Locations

Columbia Univeristy Irving Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAS5275

Identifier Type: -

Identifier Source: org_study_id