- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180566
Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes
July 2, 2021 updated by: Columbia University
Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
-
New York, New York, United States, 10032
- Columbia Univeristy Irving Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby).
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Other: 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.
|
Includes a regular growth ultrasound examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At time of delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average birth weight of participating women's babies
Time Frame: 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.
|
At time of delivery
|
Number of participating women who experienced composite maternal morbidity
Time Frame: 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.
|
At time of delivery
|
Number of participating women whose babies experienced composite neonatal morbidity
Time Frame: 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).
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At time of delivery
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Number of participating women whose babies experienced composite of abnormalities of fluid volume and growth
Time Frame: 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).
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At time of delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Gyamfi-Bannerman, MD, MSc, Professor of Obstetrics/Gyn, Columbia University
- Study Chair: Maria Andrikopoulou, MD, PhD, Postdoctoral Clinical Fellow in the Department of Obstetrics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2020
Primary Completion (Actual)
March 10, 2021
Study Completion (Actual)
March 10, 2021
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 2, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- AAAS5275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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