Congenital AnomalyNCT06628063
Examination of Pregnant Women in Third Trimester by Ultrasound to Detect Any Congenital Anomalies
An observational study of Congenital Anomaly, run by Sohag University.
Trial summary
this study aims to help the physicians to evaluate the practice of routine Third trimestric fetal scan whether it should be routinely performed to all cases including those with low risk singleton pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Anomaly
- What is being tested?
- ultrasound evaluation
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Apr 2025
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: normal pregnancies attending outpatient clinic in Sohag university Hospital
Who may be able to join
- Singleton healthy pregnancy at second and third trimesters of pregnancy.
- Fetuses were considered normal based on second trimestric fetal scan in our feto-maternal unit
Who cannot join
- Exclusion criteria were patients with multiple gestations, maternal medical complications as Preeclampsia, DM ,Cardiac or renal diseases , or fetal abnormalities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Second and Third Trimestric Scan Versus Second Trimestric Scan Alone in Detection of Congenital Fetal Anomalies
this study aims to help the physicians to evaluate the practice of routine Third trimestric fetal scan whether it should be routinely performed to all cases including those with low risk singleton pregnancies.
Read the detailed description
The third-trimester ultrasound scan ,traditionally performed at 32-34weeks, can assess fetal viability , presentation, anatomy , growth, amniotic fluid volume, placental location and fetoplacental Doppler.
There are multiple other indications that can trigger a third-trimester scan, including antepartum bleeding , reduced fetal movements, preterm rupture of the membranes and suspected abnormalities of fetal growth based on physical examination. In addition, ultrasound may be used to guide other procedures in the third trimester, such as external cephalic version. However, as yet, there is no convincing evidence that routine universal third-trimester ultrasound examination in a low-risk population improves either perinatal or maternal outcome especially in low socioeconomic countries with limited resources
- Conditions
- Congenital Anomaly
- Being tested
- ultrasound evaluation
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound evaluationOther
Ultrasound scan of fetus in second and third trimestrers
| Study group | Role | What they receive |
|---|---|---|
| normal third trimestric scam | cases in which second and third trimestric scan show no additional benefit over second trimestric scan alone Receives: Other: ultrasound evaluation | |
| new finding in third trimestric scan | cases in which second and third trimestric scan show additional benefit over second trimestric scan alone Receives: Other: ultrasound evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
newly discovered congenital anomaly at third trimester of pregnancy
assessing Additional benefit of 3rd Trimester scan in low risk pregnancies attending sohag university regarding detection pf fetal congenital anomalies
Measured: from October 2024 to April 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital AnomalyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Desouky, Sohag University
- Investigators
- Mahmoud desoky Desoky, Principal investigator, sohag university , Department of obstetric and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628063
- Sponsor's protocol ID
- soh -Med-24-09-16MS
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- 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 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second and Third Trimestric Scan Versus Second Trimestric Scan Alone in Detection of Congenital Fetal Anomalies
- ClinicalTrials.gov ID
- NCT06628063
- Acronym / sponsor ID
- soh -Med-24-09-16MS
- Conditions
- Congenital Anomaly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
this study aims to help the physicians to evaluate the practice of routine Third trimestric fetal scan whether it should be routinely performed to all cases including those with low risk singleton pregnancies.
Detailed description
The third-trimester ultrasound scan ,traditionally performed at 32-34weeks, can assess fetal viability , presentation, anatomy , growth, amniotic fluid volume, placental location and fetoplacental Doppler.
There are multiple other indications that can trigger a third-trimester scan, including antepartum bleeding , reduced fetal movements, preterm rupture of the membranes and suspected abnormalities of fetal growth based on physical examination. In addition, ultrasound may be used to guide other procedures in the third trimester, such as external cephalic version. However, as yet, there is no convincing evidence that routine universal third-trimester ultrasound examination in a low-risk population improves either perinatal or maternal outcome especially in low socioeconomic countries with limited resources
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal third trimestric scam | – | Other: ultrasound evaluationcases in which second and third trimestric scan show no additional benefit over second trimestric scan alone |
| new finding in third trimestric scan | – | Other: ultrasound evaluationcases in which second and third trimestric scan show additional benefit over second trimestric scan alone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- normal pregnancies attending outpatient clinic in Sohag university Hospital
Key inclusion criteria (2 listed)
- Singleton healthy pregnancy at second and third trimesters of pregnancy.
- Fetuses were considered normal based on second trimestric fetal scan in our feto-maternal unit
Key exclusion criteria (1 listed)
- Exclusion criteria were patients with multiple gestations, maternal medical complications as Preeclampsia, DM ,Cardiac or renal diseases , or fetal abnormalities
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 |
|---|---|---|
| ultrasound evaluationUltrasound scan of fetus in second and third trimestrers | Other | new finding in third trimestric scan, normal third trimestric scam |
Primary outcome
newly discovered congenital anomaly at third trimester of pregnancy
Time frame: from October 2024 to April 2025
assessing Additional benefit of 3rd Trimester scan in low risk pregnancies attending sohag university regarding detection pf fetal congenital anomalies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Guidelines from international society of ultrasound about fetal scanning at third trimesterLink provided by the sponsor.
- 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.
Mahmoud desoky Desoky principal investigator
sohag university , Department of obstetric and gynecology
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Anomaly, run by Sohag 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 2 inclusion and 1 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 4 Oct 2024. 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?
Contact Mahmoud desoky Desoky (01032717642, doctordesoky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
newly discovered congenital anomaly at third trimester of pregnancy (time frame: from October 2024 to April 2025). 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 4 Oct 2024.