Clinical trial NCT04180566: Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes
Official title: Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity Complicating Childbirth
Keywords: Pregnant
Pregnancy
Ultrasound
Antepartum testing
Neonatal outcome
Antenatal complications
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Average gestational age at delivery of participating women's babies
timeFrame: At time of delivery
Secondary outcomes:
measure: Average birth weight of participating women's babies
timeFrame: At time of delivery
measure: Number of participating women who experienced composite maternal morbidity
timeFrame: At time of delivery
measure: Number of participating women whose babies experienced composite neonatal morbidity
timeFrame: At time of delivery
measure: Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth
timeFrame: At time of delivery
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univeristy Irving Medical Center
state: New York
Study officials:
affiliation: Professor of Obstetrics/Gyn, Columbia University
name: Cynthia Gyamfi-Bannerman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Postdoctoral Clinical Fellow in the Department of Obstetrics
name: Maria Andrikopoulou, MD, PhD
role: STUDY_CHAIR
References: