Gestational Age and Weight ConditionsNCT04240041
Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age
An observational study of Gestational Age and Weight Conditions, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Gestational Age and Weight Conditions
- What is being tested?
- Transcerebellar diamater and Placental thickness
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2019to Jul 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 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy
Who may be able to join
- Sure of dates
- Have dating ultrasound with crown rump length between (9 to 12 )weeks
- No hormonal contraception 3 months before conception.
- Regular menstrual cycles.
- Medically free.
- Single pregnancy
- Gestational age 32-36 weeks
Who cannot join
- Irregular menstrual cycles and not sure of dates
- Multiple pregnancy.
- Fetal anomalies.
- Placenta previa, placental anomalies and poor visualization of the placenta
- Fetal growth restriction
- Pregnant women with medical disorder e.g. diabetes mellitus, Pre-eclampsia, Systemic lupus erythromatosis, hypertension.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo, Abbsia, 002
Ayat Allah Mahmoud, MbBCh, 01030717379, Drayaghoneim15@gmail.com
About this study
Official title: Accuracy of Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age: Prospective Study
Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.
- Conditions
- Gestational Age and Weight Conditions
- Being tested
- Transcerebellar diamater, Placental thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcerebellar diamaterDiagnostic test
Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, trans-cerebellar diameter is identified by obtaining an oblique view through posterior fossa that included visualization of midline thalamus, cerebellar hemispheres and cisterna magna.
Placental thicknessDiagnostic test
Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, placental thickness will be measured at the level of the umbilical cord insertion excluding the myometrium and sub-placental veins
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women at 32-36 weeks gestational age | Pregnant women at 32-36 weeks gestational age with sure dates and crown-rump length dating ultrasound Receives: Diagnostic Test: Transcerebellar diamater; Diagnostic Test: Placental thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation
Concordance between the estimated gestational age using last menstrual period and dating ultrasound; and that estimated using combination of transcerebellar diameter and placental thickness
Measured: 32-36 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start10 Jul 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Age and Weight ConditionsStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayatullah Abd ElFatah Mahmoud, Ain Shams University
- Investigators
- Ayat Allah Mahmoud, MB BCh, Principal investigator, Resident of Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240041
- Sponsor's protocol ID
- TCD/PT-GA
- Status last verified
- Jan 2020
- First submitted
- 21 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Trans-cerebellar Diameter and Placental Thickness in Third Trimesteric Pregnant Women for Calculation of Gestational Age: Prospective Study
- ClinicalTrials.gov ID
- NCT04240041
- Acronym / sponsor ID
- TCD/PT-GA
- Conditions
- Gestational Age and Weight Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 27 Jan 2020 (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.
Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy will be recruited. Ultrasonographic estimation of gestational age using combined transcerebellar diameter and placental thickness will be compared to the actual estimated gestational age.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women at 32-36 weeks gestational age | – | Diagnostic Test: Transcerebellar diamater, Diagnostic Test: Placental thicknessPregnant women at 32-36 weeks gestational age with sure dates and crown-rump length dating ultrasound |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women at 32-36 weeks gestational age with sure gestational dating (based in both last menstrual period and dating ultrasound) and otherwise normal singleton pregnancy
Key inclusion criteria (7 listed)
- Sure of dates
- Have dating ultrasound with crown rump length between (9 to 12 )weeks
- No hormonal contraception 3 months before conception.
- Regular menstrual cycles.
- Medically free.
Key exclusion criteria (6 listed)
- Irregular menstrual cycles and not sure of dates
- Multiple pregnancy.
- Fetal anomalies.
- Placenta previa, placental anomalies and poor visualization of the placenta
- Fetal growth restriction
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 |
|---|---|---|
| Transcerebellar diamaterUsing SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, trans-cerebellar diameter is identified by obtaining an oblique view through posterior fossa that included visualization of midline thalamus, cerebellar hemispheres and cisterna magna. | Diagnostic test | Pregnant women at 32-36 weeks gestational age |
| Placental thicknessUsing SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, placental thickness will be measured at the level of the umbilical cord insertion excluding the myometrium and sub-placental veins | Diagnostic test | Pregnant women at 32-36 weeks gestational age |
Primary outcome
Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation
Time frame: 32-36 weeks gestational age
Concordance between the estimated gestational age using last menstrual period and dating ultrasound; and that estimated using combination of transcerebellar diameter and placental thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- 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.
Ayat Allah Mahmoud, MB BCh principal investigator
Resident of Obstetrics & Gynecology
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 Gestational Age and Weight Conditions, 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 7 inclusion and 6 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 Jan 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?
Contact Ayat Allah Mahmoud, MB BCh (01030717379, Drayaghoneim15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between estimated gestational age and combined transcerebellar diameter and placental thickness estimation (time frame: 32-36 weeks gestational age). 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 Jan 2020.