- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03755024
WHO Fetal Growth Charts
November 25, 2018 updated by: mina eshak tawfeek khalil, Assiut University
Implementation of WHO Fetal Growth Charts in Assiut,Egypt
Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood.
Ultrasound estimation of fetal weight before birth is today very widely used in clinical practice, and, while essential for the identification and management of high-risk pregnancies,the current reference ranges used worldwide are largely based on single populations from a few high-income countries and are therefore of uncertain general applicability.
Study Overview
Detailed Description
Against this background, WHO made it a high priority to provide fetal growth charts for estimated fetal weight and common ultrasound biometric measurements intended for worldwide use.
WHO study was conducted in 10 countries including Egypt (Assiut).The study showed that fetal growth differs significantly between countries.
Growth was to a small extent influenced by maternal age, height, weight, and parity, and by fetal sex.
The study suggested that these WHO charts for growth are more suitable for international use than those commonly applied today.
However, the differences between countries, with maternal factors, and with fetal sex mean that these growth charts may need to be adjusted for local clinical use to increase their diagnostic and predictive performance.
In our setting, we are using the charts built in the ultrasound machines based on studies done in western countries.
So, it is prudent now to implement the WHO fetal growth charts in our setting
Study Type
Observational
Enrollment (Anticipated)
102
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 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of Medicine, Assiut university.
Description
Inclusion Criteria:
- They have body-mass index between 18-30;
- They have a singleton pregnancy;
- Their gestational age at entry is between 8+0 to 12+6 weeks based on last menstrual period.
- They have no history of health, environmental or economic constraints likely to impede fetal growth; need for long-term medication (including fertility treatment); smoking currently or in the previous 6 months; recurrent miscarriage; and any previous baby delivered pre-term (<37 weeks) or with a birth weight <2,500g b. Exclusion criteria:
- Multiple pregnancy
- Congenital fetal malformation (cardiac, cerebral, renal malformations, 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 |
|---|---|
|
normal group
fetuses with normal growth
|
The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:
|
|
Growth retardation group
fetuses with retarded growth
|
The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts
Time Frame: 8 months
|
correlation of fetal growth pattern with neonatal birth weight and outcome
|
8 months
|
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 (ANTICIPATED)
January 1, 2019
Primary Completion (ANTICIPATED)
January 1, 2020
Study Completion (ANTICIPATED)
May 1, 2020
Study Registration Dates
First Submitted
November 25, 2018
First Submitted That Met QC Criteria
November 25, 2018
First Posted (ACTUAL)
November 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 27, 2018
Last Update Submitted That Met QC Criteria
November 25, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- WHOFC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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