Pregnancy at Increased Risk of Fetal Congenital AnomaliesNCT07883850
Transabdominal Versus Transvaginal Ultrasound at 9-14 Weeks in High-Risk Pregnancies
An observational study of Pregnancy at Increased Risk of Fetal Congenital Anomalies, run by Mohamed Mahrous Ahmed at 1 site in Egypt.
Trial summary
This prospective observational comparative study aims to compare the visualization success rate (VSR) of transabdominal ultrasound (TAUS) and transvaginal ultrasound (TVUS) in high-risk singleton pregnancies between 9+0 to 10+6weeks and11 weeks to 13+6 weeks of gestation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy at Increased Risk of Fetal Congenital Anomalies
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Child, Adult, Older adult
Study population: Pregnant woman who met the inclusion criteria
Who may be able to join
- Pregnancy at increased risk of fetal congenital anomalies, based on the clinical assessment and predefined high-risk criteria of the study protocol..
- Acceptance of both transabdominal and transvaginal ultrasound examinations No minimum or maximum age restriction is specified in the current protocol..
- Gestational age between 9+0 and 13+6 weeks, confirmed by crown-rump length measurement at enrollment
- Pregnant women with a singleton viable intrauterine pregnancy..
Who cannot join
- Multiple pregnancy..
- Previously diagnosed fetal anomaly Refusal of transvaginal ultrasound examination.
- Non-viable pregnancy, including missed miscarriage or an embryonic pregnancy, at the time of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Select: Al-Azhar University Hospital, Assiut•
Asyut
Mohamed Mahrous Ahmed Amer, M.B.B.Ch Resident of Obstetri, 01021909534, mahrosm841@gmail.com
About this study
Official title: Transabdominal Ultrasound Versus Transvaginal Ultrasound at 9-14 Weeks in High-Risk Pregnancies: A Comparative Study
This prospective observational comparative study aims to compare the visualization success rate (VSR) of transabdominal ultrasound (TAUS) and transvaginal ultrasound (TVUS) in high-risk singleton pregnancies between 9+0 to 10+6weeks and11 weeks to 13+6 weeks of gestation. Each participant will undergo both ultrasound examinations,
Read the detailed description
Congenital anomalies are an important cause of perinatal morbidity and mortality. Early first-trimester ultrasound assessment may be limited by gestational age, maternal body habitus, and image quality. This prospective observational comparative study will be conducted at the Department of Obstetrics and Gynecology, Al-Azhar University Hospital, Assiut, EgyptEligible participants will be women with.viable singleton intrauterine pregnancies between 9+0 and 13+6 weeks of gestation who are considered to have a high-risk pregnancy and who consent to both transabdominal and transvaginal ultrasound examinations. Each participant will undergo both examinations. The study will compare the ability of TAUS and TVUS to visualize predefined fetal and pregnancy-related anatomical structures and to detect major fetal structural abnormalities.For examinations performed before 11weeks, the assessed parameters will include the gestational sac, yolk sac, crown-rump length, cardiac activity, and early structural abnormalities when visible. For examinations performed from 11+0 to 13+6 weeks, the assessed parameters will include nuchal translucency, nasal bone, intracranial translucency, early fetal anatomy, and detection of major structural abnormalities.Each assessed structure will be recorded as visualized, not visualized, or abnormal when an abnormality is detected. The primary analysis will compare the visualization success rate (VSR) between TAUS and TVUS within the same participant. No mandatory confirmatory examination is required by the study protocol; participants may be followed during the second trimester or after delivery when clinically indicated or feasible.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1(pregnant woman from 9_ 11 weeks) | Not described | |
| cohort 2 (pregnant woman from 11_14 weeks) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization Success Rate (VSR) of predefined fetal anatomical structures by TAUS versus TVUS
Measured: During the ultrasound examination at 9+0 to 13+6 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy at Increased Risk of Fetal Congenital AnomaliesStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Mahrous Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Mahrous Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883850
- Sponsor's protocol ID
- MSC/AZ.AST./ OBG024 /16/256/6/
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transabdominal Ultrasound Versus Transvaginal Ultrasound at 9-14 Weeks in High-Risk Pregnancies: A Comparative Study
- ClinicalTrials.gov ID
- NCT07883850
- Acronym / sponsor ID
- MSC/AZ.AST./ OBG024 /16/256/6/
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mohamed Mahrous AhmedUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Oct 2026 (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 prospective observational comparative study aims to compare the visualization success rate (VSR) of transabdominal ultrasound (TAUS) and transvaginal ultrasound (TVUS) in high-risk singleton pregnancies between 9+0 to 10+6weeks and11 weeks to 13+6 weeks of gestation. Each participant will undergo both ultrasound examinations,
Detailed description
Congenital anomalies are an important cause of perinatal morbidity and mortality. Early first-trimester ultrasound assessment may be limited by gestational age, maternal body habitus, and image quality. This prospective observational comparative study will be conducted at the Department of Obstetrics and Gynecology, Al-Azhar University Hospital, Assiut, EgyptEligible participants will be women with.viable singleton intrauterine pregnancies between 9+0 and 13+6 weeks of gestation who are considered to have a high-risk pregnancy and who consent to both transabdominal and transvaginal ultrasound examinations. Each participant will undergo both examinations. The study will compare the ability of TAUS and TVUS to visualize predefined fetal and pregnancy-related anatomical structures and to detect major fetal structural abnormalities.For examinations performed before 11weeks, the assessed parameters will include the gestational sac, yolk sac, crown-rump length, cardiac activity, and early structural abnormalities when visible. For examinations performed from 11+0 to 13+6 weeks, the assessed parameters will include nuchal translucency, nasal bone, intracranial translucency, early fetal anatomy, and detection of major structural abnormalities.Each assessed structure will be recorded as visualized, not visualized, or abnormal when an abnormality is detected. The primary analysis will compare the visualization success rate (VSR) between TAUS and TVUS within the same participant. No mandatory confirmatory examination is required by the study protocol; participants may be followed during the second trimester or after delivery when clinically indicated or feasible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1(pregnant woman from 9_ 11 weeks) | – | – |
| cohort 2 (pregnant woman from 11_14 weeks) | – | – |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant woman who met the inclusion criteria
Key inclusion criteria (4 listed)
- Pregnancy at increased risk of fetal congenital anomalies, based on the clinical assessment and predefined high-risk criteria of the study protocol..
- Acceptance of both transabdominal and transvaginal ultrasound examinations No minimum or maximum age restriction is specified in the current protocol..
- Gestational age between 9+0 and 13+6 weeks, confirmed by crown-rump length measurement at enrollment
- Pregnant women with a singleton viable intrauterine pregnancy..
Key exclusion criteria (3 listed)
- Multiple pregnancy..
- Previously diagnosed fetal anomaly Refusal of transvaginal ultrasound examination.
- Non-viable pregnancy, including missed miscarriage or an embryonic pregnancy, at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visualization Success Rate (VSR) of predefined fetal anatomical structures by TAUS versus TVUS
Time frame: During the ultrasound examination at 9+0 to 13+6 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- 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.
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 Pregnancy at Increased Risk of Fetal Congenital Anomalies, run by Mohamed Mahrous Ahmed 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mahrous Ahmed Amer, M.B.B.Ch Resident of Obstetric (01021909534, mahrosm841@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization Success Rate (VSR) of predefined fetal anatomical structures by TAUS versus TVUS (time frame: During the ultrasound examination at 9+0 to 13+6 weeks of gestation.). 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 21 Oct 2026.