MacrosomiaNCT02396667
Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies : A Pilot Study
An observational study of Macrosomia, run by Ain Shams University at 1 site in Egypt.
Trial summary
5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Macrosomia
- What is being tested?
- 5D ultrasound
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Sep 2022
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women between 37 and 42 weeks with macrosomic fetuses.
Who may be able to join
- 37 to 42 weeks gestation
- macrosomic fetuses
- maternal diabetes
Who cannot join
- intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies: A Pilot Study
5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.
- Conditions
- Macrosomia
- Being tested
- 5D ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5D ultrasoundOther
Measure the femur length by 5DLB to calculate fetal weight
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with macrosomia | Pregnant wo.en between 37 and 42 weeks with fetal macrosomia as suspected by clinical estimation and 2D ultrasound. Receives: Other: 5D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
Measured: 72hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start1 Jan 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacrosomiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396667
- Sponsor's protocol ID
- m2493
- Status last verified
- Jul 2020
- First submitted
- 19 Mar 2015
- Last updated
- 9 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of 5D LB Ultrasound in Prediction of Birth Weight in Macrosomic Babies: A Pilot Study
- ClinicalTrials.gov ID
- NCT02396667
- Acronym / sponsor ID
- m2493
- Conditions
- Macrosomia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- 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.
5D and 2D ultrasounds will be done for pregnant women with macrosomic fetuses to determine estimated fetal weight using hadlock formula. The accuracy of fetal weight obtained by ultrasound will be compared to actual birth weight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with macrosomia | – | Other: 5D ultrasoundPregnant wo.en between 37 and 42 weeks with fetal macrosomia as suspected by clinical estimation and 2D ultrasound. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women between 37 and 42 weeks with macrosomic fetuses.
Key inclusion criteria (3 listed)
- 37 to 42 weeks gestation
- macrosomic fetuses
- maternal diabetes
Key exclusion criteria (4 listed)
- intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts
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 |
|---|---|---|
| 5D ultrasoundMeasure the femur length by 5DLB to calculate fetal weight | Other | pregnant women with macrosomia |
Primary outcome
Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
Time frame: 72hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Related trials for Macrosomia
Active, not recruitingObservational study
Analysis on the Health of Newborns in Three Hospitals, 2008-2024
Neonatal Morbidity and Mortality, Intrauterine Growth Disorders (IUGR and Macrosomia)
Not yet recruiting
Repeat Late GDM Testing and Cesarean Delivery Rates
Large for Gestational Age (LGA), Pregnancy
Recruiting
Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
Macrosomia, Fetal Weight
Recruiting
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
Body Composition, Feeding; Difficult, Newborn
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)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Macrosomia, 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 4 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 9 Jul 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of 5D ultrasound in predicting actual birth weight in comparison to 2D ultrasound. (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight) (time frame: 72hours). 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 9 Jul 2020.