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

Not Applicable

Terminated

• Conditions: Obesity Complicating Childbirth
• Interventions: Other: Antenatal Testing (biophysical profile); Other: Ultrasound Examination

• Registration Number: NCT04180566
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-27
• Study Start: 2020-02-04
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly antenatal testing	Antenatal Testing (biophysical profile)	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.
Growth ultrasound examination every 4 weeks	Ultrasound Examination	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.

Primary Outcome Measures

Name	Time	Method
Average gestational age at delivery of participating women's babies	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 Outcome Measures

Name	Time	Method
Number of participating women who experienced composite maternal morbidity	At time of delivery	Composite maternal morbidity is defined as any of the following: chorioamnionitis, endometritis, cesarean section in labor, wound infection, transfusion, hemorrhage, deep venous thrombosis or pulmonary embolism, admission to ICU or death.
Average birth weight of participating women's babies	At time of delivery	This is to measure the body weight of a baby at birth. The average baby weighs about 7.5 pounds - though the range of normal is between 5.8 and 10 pounds.
Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth	At time of delivery	A composite of abnormalities of fluid volume and growth is defined as any of the following: oligohydramnios (AFI\<5 or maximum vertical pocket (MVP) \< 2) or polyhydramnios (AFI\>24 or MVP\>8); fetal growth restriction (EFW\<10% or AC\<5%) ; or large for gestational age (EFW\>90%), macrosomia (EFW\>4,000 grams).
Number of participating women whose babies experienced composite neonatal morbidity	At time of delivery	Composite neonatal morbidity is defined as any of the following: stillbirth after randomization, neonatal death within 28 days from birth, respiratory distress syndrome, Transient tachypnea of the newborn, hypoglycemia, sepsis, seizures, necrotizing enterocolitis, hypoxic ischemic encephalopathy, cardiopulmonary resuscitation or ventilator support within 24 h of birth, arterial blood pH\<7, 5 min Apgar score \<3, ICU admission, prolonged hospitalization (5 days or longer).

Trial Locations

Locations (1)

Columbia Univeristy Irving Medical Center; 🇺🇸 New York, New York, United States