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Body Fat Index for Obstetric Risk Stratification (BFIors)

Primary Purpose

Gestational Diabetes, Pre-Eclampsia, Labour Dystocia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women prior to 14 weeks

Exclusion Criteria:

  • Known pre-gestational diabetes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Pregnant women prior to 14 weeks

    Arm Description

    The sonographic examination will be conducted as an additional part after completing anatomical survey. . For the most accurate measurements, we will reduce the image depth to decrease the margin of error. We will conduct an initial abdominal sweep in all participants from the xiphoid to the umbilicus to detect the area of maximum pre-peritoneal fat thickness. Then, we will measure the maximum pre-peritoneal fat thickness and minimum subcutaneous fat thickness. Furthermore, all measurements will be conducted after inspiration to avoid its generated tension with the transducer just touching the skin avoiding compression of the subcutaneous fat. Two measurements will be taken to investigate the inter-observer effect. Then, BFI will be calculated using the following formula: BFI = pre-peritoneal fat (mm) x subcutaneous fat (mm) / Height (cm). Results will be communicated to the site primary investigator. The treating obstetrician will be blinded to these results.

    Outcomes

    Primary Outcome Measures

    Diagnosis of gestational diabetes (GDM)
    Diagnosis of GDM is made by abnormal glucose tolerance test during pregnancy

    Secondary Outcome Measures

    Diagnosis of pre-eclampsia Incidence of Cesarean section
    The diagnosis is made by elevated blood pressure above 140 (systolic) and/or 90 (diastolic) in association with proteinuria
    Labor dystocia
    Failure to progress in labour resulting in Cesarean section delivery

    Full Information

    First Posted
    September 5, 2022
    Last Updated
    October 11, 2022
    Sponsor
    Assiut University
    Collaborators
    Baylor College of Medicine, Middle-Eastern College of Obstetricians and Gynecologists
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05533996
    Brief Title
    Body Fat Index for Obstetric Risk Stratification
    Acronym
    BFIors
    Official Title
    Body Fat Index as a Novel Sonographic Tool to Predict High Risk Pregnancy (BFiORS Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University
    Collaborators
    Baylor College of Medicine, Middle-Eastern College of Obstetricians and Gynecologists

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Primary Outcome:- GDM Diagnosis Secondary Outcomes:- Pre-eclampsia diagnosis. Cesarean section delivery due to labor dystocia defined as protracted or arrested progress of labor using labor partogram.
    Detailed Description
    Obesity is one of the most common global risk factors for significant health issues, that has become increasingly prevalent among reproductive aged women. In the United States, obesity affects 21% in prepregnant females . Maternal obesity and excessive gestational weight gain have been linked to various adverse obstetric and neonatal outcomes, including spontaneous abortion, gestational diabetes mellitus (GDM), cesarean delivery, preeclampsia, neonatal macrosomia, and complications from surgery and anesthesia . Consequently, contemporary guidelines recommend assessment of body mass index (BMI) at the first prenatal visit to guide diet and exercise directions and stratify obstetric risks . Nevertheless, BMI is associated with limitations to its clinical significance: first, it does not accurately correlate with the body fat distribution and does not differentiate between the increased mass of body muscle, bone, or fat being dependent on the patient's height and weight . Although all pregnant women with obesity is considered at risk of developing an adverse pregnancy outcome , women with BMI > 30 kg/m2 do not necessarily develop adverse outcomes, while women with BMI < 30 can still develop significant complications . Therefore, BMI does not present a clinically sensitive tool to screen and predict obesity-relevant adverse outcomes of pregnancy, including GDM, metabolic syndrome, and pre-eclampsia . Anthropometric measurements such as waist circumference, hip circumference, waist/hip ratio, and others have been used to indicate that central fat is associated with the obesity-related adverse outcomes of pregnancy ; however, they are undermined by the subcutaneous fat amount . Computerized tomography (CT) and dual-energy X-ray absorptiometry have been implemented to measure visceral fat in the general population, which is deemed clinically related to health hazards. However, these approaches are associated with radiation exposure, associated with high costs, and are overall not appropriate for screening . Ultrasound is safe during pregnancy and is routinely used as a part of antenatal care. Ultrasound can be used to measure visceral fat with similar sensitivity to CT in measuring fat thickness . Body fat index (BFI) is a novel tool that is calculated using the following formula (BFI = pre-peritoneal fat (mm) x subcutaneous fat (mm) / Height (cm)) . BFI was reported to be a safe, cost-effective, and easy screening method to identify the obesity-related adverse outcomes of pregnancy . Being dependent on pre-peritoneal fat which was reported to correlate with GDM with a predictive advantage over waist circumference and BMI , BFI constitutes a promising screening tool that can assess obesity-related adverse outcomes of pregnancy during first trimester scan without extra-costs and with high patient satisfaction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes, Pre-Eclampsia, Labour Dystocia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    206 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pregnant women prior to 14 weeks
    Arm Type
    Other
    Arm Description
    The sonographic examination will be conducted as an additional part after completing anatomical survey. . For the most accurate measurements, we will reduce the image depth to decrease the margin of error. We will conduct an initial abdominal sweep in all participants from the xiphoid to the umbilicus to detect the area of maximum pre-peritoneal fat thickness. Then, we will measure the maximum pre-peritoneal fat thickness and minimum subcutaneous fat thickness. Furthermore, all measurements will be conducted after inspiration to avoid its generated tension with the transducer just touching the skin avoiding compression of the subcutaneous fat. Two measurements will be taken to investigate the inter-observer effect. Then, BFI will be calculated using the following formula: BFI = pre-peritoneal fat (mm) x subcutaneous fat (mm) / Height (cm). Results will be communicated to the site primary investigator. The treating obstetrician will be blinded to these results.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ultrasound
    Intervention Description
    Sonographic examination to measure the maternal pre-peritoneal fat thickness and subcutaneous fat thickness and calculate body fat index
    Primary Outcome Measure Information:
    Title
    Diagnosis of gestational diabetes (GDM)
    Description
    Diagnosis of GDM is made by abnormal glucose tolerance test during pregnancy
    Time Frame
    Between 24 and 28 weeks of pregnancy
    Secondary Outcome Measure Information:
    Title
    Diagnosis of pre-eclampsia Incidence of Cesarean section
    Description
    The diagnosis is made by elevated blood pressure above 140 (systolic) and/or 90 (diastolic) in association with proteinuria
    Time Frame
    24 weeks of pregnancy to 10 days postpartum
    Title
    Labor dystocia
    Description
    Failure to progress in labour resulting in Cesarean section delivery
    Time Frame
    At time of labour (onset of labour pain to time of delivery)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant women prior to 14 weeks Exclusion Criteria: Known pre-gestational diabetes
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    sherif shazly, MSc
    Email
    administration@mogge-obgyn.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Abuelazm
    Email
    mohamed.abuelazm.mogge@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sherif Shazly, MSc
    Organizational Affiliation
    The Leeds Teaching Hospitals NHS Trust
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ahmed Nassr, MD
    Organizational Affiliation
    Baylor College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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