Threatened MiscarriageNCT06797557
Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion
An observational study of Threatened Miscarriage, run by Cairo University at 1 site in Egypt.
Trial summary
Three or two measurements (according to GA) using 2D and 3D ultrasound examinations will be done at initial assessment of the participants then after 1 to 2 weeks and at the end of the 12th week of gestation Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Threatened Miscarriage
- What is being tested?
- 2D Ultrasound and 3D ultrasound
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 25 Jun 2026
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: One hundred and twenty women with threatened abortion.
Who may be able to join
- Age 19 -39 years
- BMI 18-25 kg/m2
- Singleton pregnancy between 6 to 11 gestational weeks of pregnancy.
- First trimester threatened abortion is usually diagnosed in women with history of vaginal bleeding or spotting and/or abdominal pain in whom a live embryo can visualized on scan
- Gestational age (GA) calculated by the last menstrual period date (LMP) in women with sure dates and regular menstrual cycles and confirmed by transvaginal sonography performed up to the 11th gestational week, using the crown-rump length
Who cannot join
- Uterine malformations or pathology as submucous myoma
- Cervical abnormalities as polypi or severe chronic cervicitis
- Chronic medical conditions as uncontrolled diabetes or hypertension
- Smoking or drug abuse during this pregnancy
- Pregnancies resulting from infertility treatments and assisted reproductive techniques.
- Women with exogenous progesterone support
- Use of abortion induction drugs\
- First trimester vaginal bleeding or spotting and/or abdominal pain and diagnosed by ultrasound as missed (absence of cardiac activity within fetal pole), incomplete (endometrial thickness between 5 to 15 mm), complete (thin and regular endometrium), anembryonic (gestational sac without a detectable fetal pole) and ectopic (+ve pregnancy test with empty gestational sac
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion: A Prospective Cohort Study
Three or two measurements (according to GA) using 2D and 3D ultrasound examinations will be done at initial assessment of the participants then after 1 to 2 weeks and at the end of the 12th week of gestation
Read the detailed description
First ultrasound scans: between 6 and 11 weeks of gestation that included the following:
- Crow- rump length (CRL) measurement using 2D ultrasound. Proper measurement of the CRL was done according to obtaining a true, unflexed, longitudinal section of the embryo or fetus, with the end-points of the crown (the top of the head) and rump (the end of the trunk) clearly defined, and then placing the calipers correctly on these defined end-points.
- Yolk sac diameter (largest outer to outer measure).
- Mean gestational sac diameter (arithmetic mean of 3 diameters).
- Embryonic heart rate. the heart rate was determined from M-mode tracings using electronic calipers .The sweep speed was set at 4 s and the calculation of the heart rate was made by measuring the time interval of two cardiac cycles, using clearly identified points in the M-mode tracing
- For volume calculation, 3D ultrasound rotational VOCAL method was used. YSV measurement (axial, sagittal and coronal). The sagittal plane was chosen as the reference plane and 'scanned' to obtain the longest axis of the yolk sac. Then a magnification of image was used and the yolk sac moved to the center of the plane. The VOCAL switch was then activated using a 30° rotation angle and the manual setting. Calipers were positioned on the superior and inferior extremities of the structure and after obtaining six sequential planes, the equipment automatically displayed the yolk sac as a 3D image with its volume in cm3.
Follow up scans was done one to two weeks later according the patient condition then at the end of 1st trimester where the previously mentioned parameters were measured.
- Conditions
- Threatened Miscarriage
- Being tested
- 2D Ultrasound, 3D ultrasound
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D UltrasoundDiagnostic test
- Crow- rump length (CRL) measurement using 2D ultrasound. Proper measurement of the CRL was done according to obtaining a true, unflexed, longitudinal section of the embryo or fetus, with the end-points of the crown (the top of the head) and rump (the end of the trunk) clearly defined, and then placing the calipers correctly on these defined end-points.
- Yolk sac diameter (largest outer to outer measure).
- Mean gestational sac diameter (arithmetic mean of 3 diameters).
- Embryonic heart rate. the heart rate was determined from M-mode tracings using electronic calipers .The sweep speed was set at 4 s and the calculation of the heart rate was made by measuring the time interval of two cardiac cycles, using clearly identified points in the M-mode tracing
3D ultrasoundDiagnostic test
3D ultrasound rotational VOCAL method was used. YSV measurement (axial, sagittal and coronal). The sagittal plane was chosen as the reference plane and 'scanned' to obtain the longest axis of the yolk sac. Then a magnification of image was used and the yolk sac moved to the center of the plane. The VOCAL switch was then activated using a 30° rotation angle and the manual setting. Calipers were positioned on the superior and inferior extremities of the structure and after obtaining six sequential planes, the equipment automatically displayed the yolk sac as a 3D image with its volume in cm3
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
continuation of pregnancy beyond 12 weeks of gestation
Measured: 12 weeks of gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Feb 2025
- Primary completion12 May 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened MiscarriageStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797557
- Sponsor's protocol ID
- N 363
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical, 2D and 3D Ultrasonographic Predictors of Pregnancy Outcome in Women With Threatened Abortion: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06797557
- Acronym / sponsor ID
- N 363
- Conditions
- Threatened Miscarriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 28 Jan 2025 (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.
Three or two measurements (according to GA) using 2D and 3D ultrasound examinations will be done at initial assessment of the participants then after 1 to 2 weeks and at the end of the 12th week of gestation
Detailed description
First ultrasound scans: between 6 and 11 weeks of gestation that included the following:
- Crow- rump length (CRL) measurement using 2D ultrasound. Proper measurement of the CRL was done according to obtaining a true, unflexed, longitudinal section of the embryo or fetus, with the end-points of the crown (the top of the head) and rump (the end of the trunk) clearly defined, and then placing the calipers correctly on these defined end-points.
- Yolk sac diameter (largest outer to outer measure).
- Mean gestational sac diameter (arithmetic mean of 3 diameters).
- Embryonic heart rate. the heart rate was determined from M-mode tracings using electronic calipers .The sweep speed was set at 4 s and the calculation of the heart rate was made by measuring the time interval of two cardiac cycles, using clearly identified points in the M-mode tracing
- For volume calculation, 3D ultrasound rotational VOCAL method was used. YSV measurement (axial, sagittal and coronal). The sagittal plane was chosen as the reference plane and 'scanned' to obtain the longest axis of the yolk sac. Then a magnification of image was used and the yolk sac moved to the center of the plane. The VOCAL switch was then activated using a 30° rotation angle and the manual setting. Calipers were positioned on the superior and inferior extremities of the structure and after obtaining six sequential planes, the equipment automatically displayed the yolk sac as a 3D image with its volume in cm3.
Follow up scans was done one to two weeks later according the patient condition then at the end of 1st trimester where the previously mentioned parameters were measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- One hundred and twenty women with threatened abortion.
Key inclusion criteria (5 listed)
- Age 19 -39 years
- BMI 18-25 kg/m2
- Singleton pregnancy between 6 to 11 gestational weeks of pregnancy.
- First trimester threatened abortion is usually diagnosed in women with history of vaginal bleeding or spotting and/or abdominal pain in whom a live embryo can visualized on scan
- Gestational age (GA) calculated by the last menstrual period date (LMP) in women with sure dates and regular menstrual cycles and confirmed by transvaginal sonography performed up to the 11th gestational week, using the crown-rump length
Key exclusion criteria (8 listed)
- Uterine malformations or pathology as submucous myoma
- Cervical abnormalities as polypi or severe chronic cervicitis
- Chronic medical conditions as uncontrolled diabetes or hypertension
- Smoking or drug abuse during this pregnancy
- Pregnancies resulting from infertility treatments and assisted reproductive techniques.
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 |
|---|---|---|
| 2D Ultrasound* Crow- rump length (CRL) measurement using 2D ultrasound. Proper measurement of the CRL was done according to obtaining a true, unflexed, longitudinal section of the embryo or fetus, with the end-points of the crown (the top of the head) and rump (the end of the trunk) clearly defined, and then placing the calipers correctly on these defined end-points. * Yolk sac diameter (largest outer to outer measure). * Mean gestational sac diameter (arithmetic mean of 3 diameters). * Embryonic heart rate. the heart rate was determined from M-mode tracings using electronic calipers .The sweep speed was set at 4 s and the calculation of the heart rate was made by measuring the time interval of two cardiac cycles, using clearly identified points in the M-mode tracing | Diagnostic test | – |
| 3D ultrasound3D ultrasound rotational VOCAL method was used. YSV measurement (axial, sagittal and coronal). The sagittal plane was chosen as the reference plane and 'scanned' to obtain the longest axis of the yolk sac. Then a magnification of image was used and the yolk sac moved to the center of the plane. The VOCAL switch was then activated using a 30° rotation angle and the manual setting. Calipers were positioned on the superior and inferior extremities of the structure and after obtaining six sequential planes, the equipment automatically displayed the yolk sac as a 3D image with its volume in cm3 | Diagnostic test | – |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks of gestational age
continuation of pregnancy beyond 12 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
Ahmed Maged principal investigator
Cairo University
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 Threatened Miscarriage, run by Cairo 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 7 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ongoing pregnancy rate (time frame: 12 weeks of 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 7 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.