Estimation of Fetal WeightSTTNCT03459989
Comparison Between Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight by Ultrasound
An observational study of Estimation of Fetal Weight, run by Ain Shams University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Estimation of Fetal Weight
- What is being tested?
- Ultrasound
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2017to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Gestational age 38 - 40 wks
- Singleton uncomplicated pregnancies
- Normal amniotic fluid volume
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Estimation of Fetal Weight
- Being tested
- Ultrasound
- Keywords
- hadlock, thigh soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Samsung H60 Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | we will measure expected fetal weight by ultrasound by hadlock's formula and thigh soft tissue for each pregnant woman Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal weight
hadlock's 4th formula and thigh soft tissue formula
Measured: 38 weeks to 40 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start15 May 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estimation of Fetal WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abd elfatah elsenity, Ain Shams University
- Investigators
- Adel SH Salah El-Din, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459989
- Sponsor's protocol ID
- 9071729
- Acronym
- STT
- Status last verified
- Aug 2018
- First submitted
- 4 Mar 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Two Dimensions Ultrasonography of Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight
- ClinicalTrials.gov ID
- NCT03459989
- Acronym / sponsor ID
- STT / 9071729
- Conditions
- Estimation of Fetal Weight
- Keywords
- hadlock, thigh soft tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | Diagnostic Test: Ultrasoundwe will measure expected fetal weight by ultrasound by hadlock's formula and thigh soft tissue for each pregnant woman |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Gestational age 38 - 40 wks
- Singleton uncomplicated pregnancies
- Normal amniotic fluid volume
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundSamsung H60 Ultrasound | Diagnostic test | pregnant women |
Primary outcome
Fetal weight
Time frame: 38 weeks to 40 weeks of gestation
hadlock's 4th formula and thigh soft tissue formula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Estimation of Fetal Weight
Recruiting
Prospective Evaluation of an AI Diagnostic Ultrasound Tool for Fetal Weight Estimation
Fetal Weight, Pregnancy
Recruiting
Impact of AI Feedback on Ultrasound Biometry Accuracy Across the Expertise Levels
Fetal Growth Abnormalities, Fetal Weight
Recruiting
Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
Macrosomia, Fetal Weight
Not yet recruitingObservational study
Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness
Fetal Macrosomia, Intrauterine Growth Disorders (IUGR and Macrosomia)
Recruiting
Comparison of Sonographic and MRI Weight Estimation in Fetuses with Suspected Macrosomia
Accuracy of Sonographic Vs MRI Fetal Weight Estimation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel SH Salah El-Din, Professor study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Estimation of Fetal Weight, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elsenity, Lecturer (+201226573332, m.elsenity@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal weight (time frame: 38 weeks to 40 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.