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Body Fat Index for Obstetric Risk Stratification (BFIors)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05533996
Recruitment Status : Not yet recruiting
First Posted : September 9, 2022
Last Update Posted : October 13, 2022
Baylor College of Medicine
Middle-Eastern College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Sherif Abdelkarim Mohammed Shazly, The Leeds Teaching Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Pre-Eclampsia Labour Dystocia Diagnostic Test: ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Body Fat Index as a Novel Sonographic Tool to Predict High Risk Pregnancy (BFiORS Trial)
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Pregnant women prior to 14 weeks

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.

Diagnostic Test: ultrasound
Sonographic examination to measure the maternal pre-peritoneal fat thickness and subcutaneous fat thickness and calculate body fat index

Primary Outcome Measures :
  1. Diagnosis of gestational diabetes (GDM) [ Time Frame: Between 24 and 28 weeks of pregnancy ]
    Diagnosis of GDM is made by abnormal glucose tolerance test during pregnancy

Secondary Outcome Measures :
  1. Diagnosis of pre-eclampsia Incidence of Cesarean section [ Time Frame: 24 weeks of pregnancy to 10 days postpartum ]
    The diagnosis is made by elevated blood pressure above 140 (systolic) and/or 90 (diastolic) in association with proteinuria

  2. Labor dystocia [ Time Frame: At time of labour (onset of labour pain to time of delivery) ]
    Failure to progress in labour resulting in Cesarean section delivery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Pregnant women prior to 14 weeks

Exclusion Criteria:

  • Known pre-gestational diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05533996

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Contact: sherif shazly, MSc administration@mogge-obgyn.com
Contact: Mohamed Abuelazm mohamed.abuelazm.mogge@gmail.com

Sponsors and Collaborators
Assiut University
Baylor College of Medicine
Middle-Eastern College of Obstetricians and Gynecologists
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Principal Investigator: Sherif Shazly, MSc The Leeds Teaching Hospitals NHS Trust
Principal Investigator: Ahmed Nassr, MD Baylor College of Medicine
CDC. Body mass index: Considerations for practitioners. Cdc [Internet]. 2011;4.

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Responsible Party: Sherif Abdelkarim Mohammed Shazly, Principal Investigator, The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT05533996    
Other Study ID Numbers: MCOG-RCT02
First Posted: September 9, 2022    Key Record Dates
Last Update Posted: October 13, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypertension, Pregnancy-Induced
Obstetric Labor Complications