- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401438
Accuracy of 5D LB Ultrasound in Predicting Birth Weight of Preterm Fetuses : A Pilot Study
July 7, 2020 updated by: dr mohamed laban, Ain Shams University
5D and 2D ultrasound will be done for pregnant women within 72hours before preterm delivery to determine estimated fetal weight by ultrasound.
The estimated fetal weight by 5D and 2D ultrasound will be compared to the actual birth weight to determine accuracy of 5D ultrasound in predicting actual birth weight .
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammed Laban, MD
- Email: laban63@yahoo.com
Study Contact Backup
- Name: Alaa Hassanin, MD
- Phone Number: 01002554281
- Email: alaasayed80@hotmail.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Ain Shams Maternity Hospital
-
Contact:
- Mohammed Laban, MD
- Email: laban63@yahoo.com
-
Contact:
- Alaa Hassanin, MD
- Phone Number: 01002554281
- Email: alaasayed80@hotmail.com
-
Principal Investigator:
- mohammed Laban, MD
-
Sub-Investigator:
- alaa hassanin, MD
-
-
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
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant women between 28 and 34 weeks scheduled for termination of pregnancy due to medical or obstetric cause
Description
Inclusion Criteria:
- 28 to 34 weeks
- preterm termination of pregnancy
- singleton pregnancy
- any obstetric or medical cause for termination of pregnancy
Exclusion Criteria:
- IUFD
- multiple pregnancy
- congenital anomalies
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pregnant women with preterm delivery
5D LB and 2D ultrasounds will be done to pregnant women between 28 and 34 weeks planned for termination of pregnancy for obstetric or medical causes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of 5D ultrasound in predicting actual birth weight in preterm fetuses
Time Frame: 72hours
|
Sensitivity specificity positive predictive value and negative predictive values will be determined
|
72hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 1, 2015
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
March 19, 2015
First Submitted That Met QC Criteria
March 24, 2015
First Posted (Estimate)
March 27, 2015
Study Record Updates
Last Update Posted (Actual)
July 8, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- m2494
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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