Birth WeightNCT05362175
Cross Sectional Area of Umbilical Cord Versus Hadlock's Formula in Prediction of Neonatal Birth Weight
An observational study of Birth Weight and Fetal Body Weight, run by Ain Shams University at 1 site in Egypt.
Trial summary
Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight, Fetal Body Weight
- What is being tested?
- Obstetric ultrasound
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 15 Apr 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women at term gestation admitted at labor room or prepared for cesarean section
Who may be able to join
- Pregnant women with:
- Age: 18-35 years.
- Singleton living fetus.
- Term gestation (37wks_ 41wks+6days). (Spong , 2013).
- Admitted at labor room or prepared for caesarean section
Who cannot join
- o Intrauterine Dead fetus (IUFD).
- Structurally malformed fetus or umbilical cord (single umbilical artery; SUA).
- Multiple pregnancies.
- Oligohydraminos (AFI < 5cm or DVP <2 cm) or polyhydraminos (AFI > 25 cm or DVP > 8 cm) (Morteza et al., 2018).
- Uterine fibroid.
- Abnormal Doppler flowmetry of umbilical artery.
- Maternal diseases (Diabetes mellitus, Hypertensive disorders, renal diseases, Ischemic heart diseases), history of drug intake (Antihypertensive, antiepileptic, oral hypoglycemic drugs).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy Between Ultrasound Measurement of Cross Sectional Area of the Umbilical Cord and Hadlock's Formula in Prediction of Neonatal Birth Weight at Term Gestation:Cross Sectional Study
Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality.
Read the detailed description
Umbilical cord is a vital structure of maternal-fetal life that can be used to evaluate pregnancy outcomes. In the past, sonographic investigations of the umbilical cord were limited to identification of the number of vessels and Doppler evaluation of the blood flow. Various formulas have developed to calculate Estimated Fetal Weight (EFW) using fetal biometry. While it is being accurate to a degree, they are associated with error especially with extreme birth weight. In this study using the ultrasound to look for a relation between the umbilical cord cross sectional area and estimated birth weight, as it's easy to use and readily available, comparing the estimated birth weight obtained by this method with that of Hadlock's formula measures at term gestation. Trying to prove that the umbilical cord area formula might gave advocacy for future usage for birth weight prediction.
- Conditions
- Birth Weight, Fetal Body Weight
- Being tested
- Obstetric ultrasound
- Keywords
- Birth weight, Hadlock's formula, Cross sectional area of umbilical cord, Umbilical cord, Fetal biometry
- Medical subject headings
- Birth Weight, Fetal Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric ultrasoundDevice
ultrasound measurement of the cross sectional area of umbilical cord within 1 cm from the cord insertion in to fetal abdomen and the standard Hadlock's formula
| Study group | Role | What they receive |
|---|---|---|
| Cross sectional area of umbilical cord and Hadlock's formula | Ultrasound measurement of cross sectional area of umbilical cord within 1 cm from the umbilical cord insertion into the fetal abdomen And Fetal biometry using the standard Hadlock's formula Receives: Device: Obstetric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated fetal weight calculation by hadlock's formula and by umbilical cord cross sectional area ,then correlation with actual birth weight measured with in 1st hour of delivary
correlation with actual birth weight measured
Measured: 1st hour of delivary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start15 Jul 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth WeightStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mena shafeek Ibrahim ghaly, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362175
- Sponsor's protocol ID
- Ain Shams University Hos
- Status last verified
- May 2022
- First submitted
- 26 Aug 2021
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy Between Ultrasound Measurement of Cross Sectional Area of the Umbilical Cord and Hadlock's Formula in Prediction of Neonatal Birth Weight at Term Gestation:Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05362175
- Acronym / sponsor ID
- Ain Shams University Hos
- Conditions
- Birth Weight, Fetal Body Weight
- Keywords
- Birth weight, Hadlock's formula, Cross sectional area of umbilical cord, Umbilical cord, Fetal biometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 5 May 2022 (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.
Ultrasound measurement of cross sectional area of umbilical cord might offer advantage over Hadlock's formula for accurate estimation of actual birth weight at term gestation leading to prevention of large number of maternal and neonatal morbidity and mortality.
Detailed description
Umbilical cord is a vital structure of maternal-fetal life that can be used to evaluate pregnancy outcomes. In the past, sonographic investigations of the umbilical cord were limited to identification of the number of vessels and Doppler evaluation of the blood flow. Various formulas have developed to calculate Estimated Fetal Weight (EFW) using fetal biometry. While it is being accurate to a degree, they are associated with error especially with extreme birth weight. In this study using the ultrasound to look for a relation between the umbilical cord cross sectional area and estimated birth weight, as it's easy to use and readily available, comparing the estimated birth weight obtained by this method with that of Hadlock's formula measures at term gestation. Trying to prove that the umbilical cord area formula might gave advocacy for future usage for birth weight prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross sectional area of umbilical cord and Hadlock's formula | – | Device: Obstetric ultrasoundUltrasound measurement of cross sectional area of umbilical cord within 1 cm from the umbilical cord insertion into the fetal abdomen And Fetal biometry using the standard Hadlock's formula |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women at term gestation admitted at labor room or prepared for cesarean section
Key inclusion criteria (5 listed)
- Pregnant women with:
Key exclusion criteria (7 listed)
- o Intrauterine Dead fetus (IUFD).
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 |
|---|---|---|
| Obstetric ultrasoundultrasound measurement of the cross sectional area of umbilical cord within 1 cm from the cord insertion in to fetal abdomen and the standard Hadlock's formula | Device | Cross sectional area of umbilical cord and Hadlock's formula |
Primary outcome
Estimated fetal weight calculation by hadlock's formula and by umbilical cord cross sectional area ,then correlation with actual birth weight measured with in 1st hour of delivary
Time frame: 1st hour of delivary
correlation with actual birth weight measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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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 Birth Weight and Fetal Body 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 5 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimated fetal weight calculation by hadlock's formula and by umbilical cord cross sectional area ,then correlation with actual birth weight measured with in 1st hour of delivary (time frame: 1st hour of delivary). 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 5 May 2022.