Placental VolumeNCT06561490
Placental Thickness And Volume Nomogram In Normal Singleton Pregnancies Between 11th And 18th Week Gestational Age
An observational study of Placental Volume, run by Sohag University.
Trial summary
Measurement of placental thickness and volume has a great importance in predicting adverse outcome specially in combination with other markers. In order to determine abnormalities in placental thickness and volume, we should have a normal range of values and this can be achieved by a nomogram Read more about this study
- Who is it for?
- Ages 14 to 60 years, women only
- Conditions the study is for
- Placental Volume
- What is being tested?
- sonographic assesment of placental thickness and volume
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 1 Feb 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 14 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse
Who may be able to join
- Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse
Who cannot join
- Maternal Diseases Fetal anomalies Placenta previa, placental anomalies and poor visualization of the placenta Multiple pregnancies Unreliable gestational age
Trial locations and contacts
No sites are listed yet.
Allam m Abdemonem, professor contact
About this study
Measurement of placental thickness and volume has a great importance in predicting adverse outcome specially in combination with other markers.
In order to determine abnormalities in placental thickness and volume, we should have a normal range of values and this can be achieved by a nomogram
- Conditions
- Placental Volume
- Being tested
- sonographic assesment of placental thickness and volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonographic assesment of placental thickness and volumeRadiation
sonographic assesment of placental thickness and volume
| Study group | Role | What they receive |
|---|---|---|
| placental volume and thickness in normal singleton pregnancy | Not described Receives: Radiation: sonographic assesment of placental thickness and volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
placental thickness
placental thickness in normal singleton pregnancy between 11th and 18 th week gestational age
Measured: 6 months
placental volume
placental volume in normal singleton pregnancy between 11th and 18 th week gestational age
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Placental VolumeStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hossam eldeen mostafa abdelkhalek, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561490
- Sponsor's protocol ID
- Soh-Med-24-07-01MS
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karthikeyan T, Subramaniam RK, Johnson W, Prabhu K. Placental thickness & its correlation to gestational age & foetal growth parameters- a cross sectional ultrasonographic study. J Clin Diagn Res. 2012 Dec;6(10):1732-5. doi: 10.7860/JCDR/2012/4867.2652. Epub 2012 Dec 15.
PubMed 23373039Wolfson RN, Zador IE, Halvorsen P, Andrews B, Sokol RJ. Biparietal diameter in premature rupture of membranes: errors in estimating gestational age. J Clin Ultrasound. 1983 Sep;11(7):371-4. doi: 10.1002/jcu.1870110705.
PubMed 6415121
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Thickness And Volume Nomogram In Normal Singleton Pregnancies Between 11th And 18th Week Gestational Age
- ClinicalTrials.gov ID
- NCT06561490
- Acronym / sponsor ID
- Soh-Med-24-07-01MS
- Conditions
- Placental Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 20 Aug 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.
Measurement of placental thickness and volume has a great importance in predicting adverse outcome specially in combination with other markers.
In order to determine abnormalities in placental thickness and volume, we should have a normal range of values and this can be achieved by a nomogram
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| placental volume and thickness in normal singleton pregnancy | – | Radiation: sonographic assesment of placental thickness and volume |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse
Key inclusion criteria (1 listed)
- Singleton pregnancies,11-18 weeks Reliable LMP Cases of ICSI with accurate date of transfer Cases of IUI with accurate date of IUI Cases of timed intercourse
Key exclusion criteria (1 listed)
- Maternal Diseases Fetal anomalies Placenta previa, placental anomalies and poor visualization of the placenta Multiple pregnancies Unreliable gestational age
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 |
|---|---|---|
| sonographic assesment of placental thickness and volumesonographic assesment of placental thickness and volume | Radiation | placental volume and thickness in normal singleton pregnancy |
Primary outcome
placental thickness
Time frame: 6 months
placental thickness in normal singleton pregnancy between 11th and 18 th week gestational age
placental volume
Time frame: 6 months
placental volume in normal singleton pregnancy between 11th and 18 th week gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 23373039Karthikeyan T, Subramaniam RK, Johnson W, Prabhu K. Placental thickness & its correlation to gestational age & foetal growth parameters- a cross sectional ultrasonographic study. J Clin Diagn Res. 2012 Dec;6(10):1732-5. doi: 10.7860/JCDR/2012/4867.2652. Epub 2012 Dec 15.
- Background: PubMed 6415121Wolfson RN, Zador IE, Halvorsen P, Andrews B, Sokol RJ. Biparietal diameter in premature rupture of membranes: errors in estimating gestational age. J Clin Ultrasound. 1983 Sep;11(7):371-4. doi: 10.1002/jcu.1870110705.
- Individual participant dataSharing planned: Undecided
Related trials for Placental Volume
Not yet recruitingObservational study
Placental Thickness -To-Fetal Weight Ratio as a Predictor of Adverse Pregnancy Outcome
Placental Thickness, PLACENTA VOLUME
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.
Allam m Abdemonem, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Placental Volume, 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 1 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 20 Aug 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 hossam eldeen m Abdelkhalek, resident (01060722021, hossameldien_mostafa_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
placental thickness (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561490, which also lists 2 linked publications.
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 20 Aug 2024.