- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459989
Comparison Between Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight by Ultrasound (STT)
August 26, 2018 updated by: Mohamed abd elfatah elsenity, Ain Shams University
Accuracy of Two Dimensions Ultrasonography of Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight
We are going to do 2d ultrasound to compare between hadlock's formula and thigh soft tissue formula in expecting the after birth fetal weight and to find which of these formulas to be more accurate
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
We are going to do 2d ultrasound to 200 pregnant women between 38 weeks to 40 weeks singleton pregnancy in Ain Shams University Maternity Hospital to measure the expected fetal weight by hadlock's formula and thigh soft tissue formula and then we are going to measure the actual fetal weight after birth of these 200 fetuses and to find out which formula to be more accurate in estimation of fetal weight
Study Type
Observational
Enrollment (Anticipated)
200
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
-
-
-
Cairo, Egypt
- Recruiting
- Ain Shams Universitiy
-
-
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
19 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The study population comprises 200 pregnant women at 38 to 40 week of gestation attending outpatient clinic and emergency Ain Shams University Maternity Hospital, Obstetrics and Gynaecology Department, Faculty of medicine.
Description
Inclusion Criteria:
- Gestational age 38 - 40 wks
- Singleton uncomplicated pregnancies
- Normal amniotic fluid volume
Exclusion Criteria:
Women with one of the following conditions:
- Fetuses with congenital anomalies,
- The biometric measurements of those, which were unable to ascertain due to reasons like deeply engaged head, very thick abdominal wall etc.
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
we will measure expected fetal weight by ultrasound by hadlock's formula and thigh soft tissue for each pregnant woman
|
Samsung H60 Ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal weight
Time Frame: 38 weeks to 40 weeks of gestation
|
hadlock's 4th formula and thigh soft tissue formula
|
38 weeks to 40 weeks of gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Adel SH Salah El-Din, Professor, Ain Shams University
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)
May 15, 2017
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
October 30, 2018
Study Registration Dates
First Submitted
March 4, 2018
First Submitted That Met QC Criteria
March 4, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2018
Last Update Submitted That Met QC Criteria
August 26, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9071729
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
product manufactured in and exported from the U.S.
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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