Fetal Growth ComplicationsNCT03755024
WHO Fetal Growth Charts
An observational study of Fetal Growth Complications, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fetal Growth Complications
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to May 2020
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of Medicine, Assiut university.
Who may be able to join
- 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.)
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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
- Conditions
- Fetal Growth Complications
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:
- Biparietal diameter
- Head circumference
- Abdominal circumference
- Femur length
- Humerus length
| Study group | Role | What they receive |
|---|---|---|
| normal group | fetuses with normal growth Receives: Device: ultrasound | |
| Growth retardation group | fetuses with retarded growth Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts
correlation of fetal growth pattern with neonatal birth weight and outcome
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mina eshak tawfeek khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755024
- Sponsor's protocol ID
- WHOFC
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of WHO Fetal Growth Charts in Assiut,Egypt
- ClinicalTrials.gov ID
- NCT03755024
- Acronym / sponsor ID
- WHOFC
- Conditions
- Fetal Growth Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Nov 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal group | – | Device: ultrasoundfetuses with normal growth |
| Growth retardation group | – | Device: ultrasoundfetuses with retarded growth |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women attending Antenatal care clinic of Women's Health Hospital, Faculty of Medicine, Assiut university.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ultrasoundThe compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters: * Biparietal diameter * Head circumference * Abdominal circumference * Femur length * Humerus length | Device | Growth retardation group, normal group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Complications, run by Assiut University.
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 6 inclusion and 0 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Proportion of fetuses with abnormal fetal growth diagnosed using WHO fetal charts (time frame: 8 months). 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 27 Nov 2018.