Body Fat Index for Obstetric Risk Stratification (BFIors)

October 11, 2022 updated by: Sherif Abdelkarim Mohammed Shazly, Assiut University

Body Fat Index as a Novel Sonographic Tool to Predict High Risk Pregnancy (BFiORS Trial)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women prior to 14 weeks

Exclusion Criteria:

  • Known pre-gestational diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between 24 and 28 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks of pregnancy to 10 days postpartum
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
At time of labour (onset of labour pain to time of delivery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Baylor College of Medicine
Middle-Eastern College of Obstetricians and Gynecologists

Investigators

  • Principal Investigator: Sherif Shazly, MSc, The Leeds Teaching Hospitals Nhs Trust
  • Principal Investigator: Ahmed Nassr, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCOG-RCT02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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