- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05362175
Cross Sectional Area of Umbilical Cord Versus Hadlock's Formula in Prediction of Neonatal Birth Weight
May 3, 2022 updated by: Mena shafeek Ibrahim ghaly, Ain Shams University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
220
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, 11511
- Ain Shams University
-
-
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
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant women at term gestation admitted at labor room or prepared for cesarean section
Description
Inclusion Criteria:
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
Exclusion Criteria:
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).
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 |
---|---|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1st hour of delivary
|
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 (ACTUAL)
July 15, 2021
Primary Completion (ACTUAL)
April 15, 2022
Study Completion (ACTUAL)
April 15, 2022
Study Registration Dates
First Submitted
August 26, 2021
First Submitted That Met QC Criteria
May 3, 2022
First Posted (ACTUAL)
May 5, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ain Shams University Hos
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
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.
Clinical Trials on Birth Weight
-
Society for Applied StudiesGrand Challenges CanadaCompleted
-
Foundation for Advanced Studies on International...St.Luke's Life Science Institute, Tokyo, JapanCompleted
-
Society for Applied StudiesCentre For International HealthCompleted
-
Nantes University HospitalTerminated
-
OSF Healthcare SystemCompleted
-
The Hospital for Sick ChildrenCompletedInfant, Low Birth WeightCanada, Bangladesh
-
Meiji Co., Ltd.CompletedLow Birth Weight InfantsThailand
-
University of the PhilippinesPfizerCompletedLow Birth Weight Among NeonatesPhilippines
-
Children's Hospital of Fudan UniversityCompleted
-
Children's Hospital of Fudan UniversityNot yet recruitingVery Low Birth Weight InfantChina
Clinical Trials on Obstetric ultrasound
-
Assiut UniversityNot yet recruitingShoulder Dystocia | Macrosomia, Fetal | Large for Gestational Age
-
Bridge to Health Medical and DentalKigezi Healthcare FoundationCompletedMaternal Health | Antenatal Care
-
National Cheng Kung UniversityMinistry of Science and Technology, TaiwanRecruiting
-
Maastricht University Medical CenterSchool for Midwifery MaastrichtCompleted
-
University of Campania "Luigi Vanvitelli"Completed
-
Brno University HospitalMasaryk University; Institute of Biostatistics and Analyses, Masaryk University... and other collaboratorsNot yet recruitingObstetric Anesthesia CareCzechia
-
Cengiz Gokcek Women's and Children's HospitalRecruiting
-
Oslo University HospitalEnrolling by invitationUrinary Incontinence | Sexual Dysfunction | Anal Incontinence | Obstetric Anal Sphincter InjuryNorway
-
Ankara UniversityCompletedParturition | Obstetric; Injury Pelvic Floor