Amniotic Fluid Scoring ModelNCT07315243
Modified Amniotic Fluid Score With Fetal Bladder Assessment
An observational study of Amniotic Fluid Scoring Model and Fetal Bladder Assessment, run by Assiut University.
Trial summary
This study will prospectively enroll pregnant women with singleton pregnancies between 20 and 38 weeks of gestation who attend Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Amniotic Fluid Scoring Model, Fetal Bladder Assessment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 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 18 to 45 years
- Women only
- Adult
Study population: Pregnant women aged 18-45 years with singleton pregnancies between 20 and 38 weeks of gestation attending the Obstetrics and Gynecology Department at Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid volume.
Who may be able to join
- Pregnant women aged 18-45 years.
- Singleton pregnancy between 20 and 38 weeks of gestation.
- Women attending Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid volume.
- No known major fetal anomalies at the time of inclusion.
- Able and willing to provide written informed consent.
Who cannot join
- Multiple pregnancy (e.g., twins, triplets).
- Pregnancies with known chromosomal or major structural fetal anomalies diagnosed prior to enrollment.
- Maternal systemic diseases known to affect amniotic fluid volume (e.g., pregestational or gestational diabetes, chronic hypertension, renal disease).
- Contraindications to ultrasound examination.
- Inability to provide informed consent or anticipated poor compliance with study procedures.
About this study
Official title: Modified Amniotic Fluid Scoring Model Incorporating Fetal Bladder Assessment
This study will prospectively enroll pregnant women with singleton pregnancies between 20 and 38 weeks of gestation who attend Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid. The aim is to develop and validate a modified amniotic fluid scoring model that combines standard ultrasound measures of amniotic fluid volume with fetal bladder size and appearance. The study will compare the ability of this new scoring model to detect abnormal amniotic fluid volume against conventional ultrasound methods and will explore how fetal bladder measurements relate to amniotic fluid indices.
Read the detailed description
This prospective observational cohort study will be conducted in the Obstetrics and Gynecology Department at Assiut University Hospital and will enroll 70 pregnant women aged 18-45 years with singleton pregnancies between 20 and 38 weeks of gestation who are referred for routine or clinically indicated ultrasound assessment of amniotic fluid volume. The study aims to develop and validate a modified amniotic fluid scoring model that integrates standard sonographic measures of amniotic fluid volume, including the amniotic fluid index and single deepest pocket, with predefined fetal bladder parameters such as bladder presence, morphology, and longitudinal and transverse diameters measured at maximal filling.
Eligible participants will undergo a standardized ultrasound examination using a high-resolution machine with a curvilinear transducer; the uterus will be systematically scanned to obtain AFI and single deepest pocket measurements, followed by a dedicated five-minute assessment of the fetal bladder to document its size, appearance, and any observed micturition events. All sonographic assessments will be performed by experienced sonographers following uniform protocols, and approximately 10 percent of examinations will be re-scanned by a second sonographer to assess interobserver reliability, with images and measurements digitally archived for blinded review.
- Keywords
- Modified Amniotic Fluid Scoring Model, Fetal Bladder Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity Of The Modified Amniotic Fluid Scoring Model
Proportion of pregnancies with abnormal amniotic fluid volume (oligohydramnios or polyhydramnios) correctly identified as abnormal by the modified amniotic fluid scoring model incorporating fetal bladder assessment, using conventional ultrasound assessment (AFI/SDP) as the reference standard.
Measured: At the index obstetric ultrasound examination during pregnancy (single visit per participant).
Secondary outcomes (1)
Correlation Between Fetal Bladder Size And Amniotic Fluid Volume
Correlation coefficient between fetal bladder dimensions (longitudinal and transverse diameters measured at maximal filling) and amniotic fluid volume indices (AFI and single deepest pocket) to assess the relationship between bladder size and amniotic fluid volume.
Measured: At the same index obstetric ultrasound examination during pregnancy (single visit per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic Fluid Scoring ModelStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Eldin Ali Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315243
- Sponsor's protocol ID
- Modified Amniotic Fluid Score
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Amniotic Fluid Scoring Model Incorporating Fetal Bladder Assessment
- ClinicalTrials.gov ID
- NCT07315243
- Acronym / sponsor ID
- Modified Amniotic Fluid Score
- Keywords
- Modified Amniotic Fluid Scoring Model, Fetal Bladder Assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Jan 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 study will prospectively enroll pregnant women with singleton pregnancies between 20 and 38 weeks of gestation who attend Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid. The aim is to develop and validate a modified amniotic fluid scoring model that combines standard ultrasound measures of amniotic fluid volume with fetal bladder size and appearance. The study will compare the ability of this new scoring model to detect abnormal amniotic fluid volume against conventional ultrasound methods and will explore how fetal bladder measurements relate to amniotic fluid indices.
Detailed description
This prospective observational cohort study will be conducted in the Obstetrics and Gynecology Department at Assiut University Hospital and will enroll 70 pregnant women aged 18-45 years with singleton pregnancies between 20 and 38 weeks of gestation who are referred for routine or clinically indicated ultrasound assessment of amniotic fluid volume. The study aims to develop and validate a modified amniotic fluid scoring model that integrates standard sonographic measures of amniotic fluid volume, including the amniotic fluid index and single deepest pocket, with predefined fetal bladder parameters such as bladder presence, morphology, and longitudinal and transverse diameters measured at maximal filling.
Eligible participants will undergo a standardized ultrasound examination using a high-resolution machine with a curvilinear transducer; the uterus will be systematically scanned to obtain AFI and single deepest pocket measurements, followed by a dedicated five-minute assessment of the fetal bladder to document its size, appearance, and any observed micturition events. All sonographic assessments will be performed by experienced sonographers following uniform protocols, and approximately 10 percent of examinations will be re-scanned by a second sonographer to assess interobserver reliability, with images and measurements digitally archived for blinded review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women aged 18-45 years with singleton pregnancies between 20 and 38 weeks of gestation attending the Obstetrics and Gynecology Department at Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid volume.
Key inclusion criteria (5 listed)
- Pregnant women aged 18-45 years.
- Singleton pregnancy between 20 and 38 weeks of gestation.
- Women attending Assiut University Hospital for routine or indicated ultrasound assessment of amniotic fluid volume.
- No known major fetal anomalies at the time of inclusion.
- Able and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Multiple pregnancy (e.g., twins, triplets).
- Pregnancies with known chromosomal or major structural fetal anomalies diagnosed prior to enrollment.
- Maternal systemic diseases known to affect amniotic fluid volume (e.g., pregestational or gestational diabetes, chronic hypertension, renal disease).
- Contraindications to ultrasound examination.
- Inability to provide informed consent or anticipated poor compliance with study procedures.
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
Sensitivity Of The Modified Amniotic Fluid Scoring Model
Time frame: At the index obstetric ultrasound examination during pregnancy (single visit per participant).
Proportion of pregnancies with abnormal amniotic fluid volume (oligohydramnios or polyhydramnios) correctly identified as abnormal by the modified amniotic fluid scoring model incorporating fetal bladder assessment, using conventional ultrasound assessment (AFI/SDP) as the reference standard.
1 secondary outcome
Correlation Between Fetal Bladder Size And Amniotic Fluid Volume
Time frame: At the same index obstetric ultrasound examination during pregnancy (single visit per participant).
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 2 Jan 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Amniotic Fluid Scoring Model and Fetal Bladder Assessment, run by Assiut 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Jan 2026. 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?
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?
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?
Sensitivity Of The Modified Amniotic Fluid Scoring Model (time frame: At the index obstetric ultrasound examination during pregnancy (single visit per participant).). 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 2 Jan 2026.