Fetal Growth Retardation Clinical Trial
Official title:
Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume
NCT number | NCT03002246 |
Other study ID # | H-39343 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 6, 2017 |
Est. completion date | January 31, 2019 |
Verified date | July 2019 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This trial is a collaborative study between 4 sites worldwide. A total of 600 research subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software to improve on estimated fetal weight predictions over a broad range of gestational ages. The purpose is to compare the accuracy and precision of birth weight predictions based on this new technology as compared to the current 2D birth weight prediction models.
Status | Completed |
Enrollment | 330 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: 1. Pregnant women (28-42 weeks) within 4-7 days of delivery 2. Planned delivery at the collaborating hospital where the fetal US scan was performed 3. Body mass index at first official prenatal appointment below 35.0 kg/M2 4. Firm US dating criteria (early crown-rump length < 14 weeks gestational age) Exclusion Criteria: 1. Presence of technical factors (e.g. obesity) that make it difficult to visualize fetal structures 2. Oligohydramnios determined by amniotic fluid index less than 5cm 3. Fetal distress or unstable maternal condition 4. Structural or chromosomal fetal anomalies |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Beijing Obstetrics and Gynecology Hospital, Frauenklinik der Diakonischen Dienste Hannover, Samsung Medison Co., Ltd., University of Pittsburgh |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison Between 5D Limb Vol and 2D Birth weight Prediction | Compare the accuracy and precision of BW predictions based on 5D Limb Vol technology in pregnant women as compared to 2D BW prediction models | Feb 2017 -Feb 2018 | |
Secondary | Birth weight Predictions in Suspected Growth Abnormalities | Characterize the performance of BW predictions based on 5D Limb Vol technology in pregnant women with suspected growth abnormalities. | Feb 2017 - Feb 2018 |
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