Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
Study NCT ID:
NCT04180566
Status:
TERMINATED
Last Update Posted:
2021-07-07
First Post:
2019-11-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weekly Antepartum Testing in Women With BMI 30-40 and Neonatal Outcomes
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Does Weekly Antepartum Testing in Women With BMI 30-40 Improve Neonatal Outcomes: A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: