Body Fat Index for Obstetric Risk Stratification

Gestational Diabetes Clinical Trial

— BFIors  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05533996
• Other study ID #: MCOG-RCT02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: sherif shazly, MSc
• Email: administration[@]mogge-obgyn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women prior to 14 weeks

Exclusion Criteria:

• Known pre-gestational diabetes

Related Conditions & MeSH terms

• Diabetes, Gestational
• Dystocia
• Eclampsia
• Gestational Diabetes
• Labour Dystocia
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assiut University	Baylor College of Medicine, Middle-Eastern College of Obstetricians and Gynecologists

References & Publications (15)

ACOG Practice Bulletin No 156: Obesity in Pregnancy. Obstet Gynecol. 2015 Dec;126(6):e112-e126. doi: 10.1097/AOG.0000000000001211. Erratum in: Obstet Gynecol. 2016 Dec;128(6):1450. — View Citation

Bray GA, Jablonski KA, Fujimoto WY, Barrett-Connor E, Haffner S, Hanson RL, Hill JO, Hubbard V, Kriska A, Stamm E, Pi-Sunyer FX; Diabetes Prevention Program Research Group. Relation of central adiposity and body mass index to the development of diabetes in the Diabetes Prevention Program. Am J Clin Nutr. 2008 May;87(5):1212-8. — View Citation

CDC. Body mass index: Considerations for practitioners. Cdc [Internet]. 2011;4.

Chatzi L, Plana E, Daraki V, Karakosta P, Alegkakis D, Tsatsanis C, Kafatos A, Koutis A, Kogevinas M. Metabolic syndrome in early pregnancy and risk of preterm birth. Am J Epidemiol. 2009 Oct 1;170(7):829-36. doi: 10.1093/aje/kwp211. Epub 2009 Aug 27. — View Citation

Fitzsimons KJ, Modder J; Centre for Maternal and Child Enquires. Setting maternity care standards for women with obesity in pregnancy. Semin Fetal Neonatal Med. 2010 Apr;15(2):100-7. doi: 10.1016/j.siny.2009.09.004. Epub 2009 Nov 25. — View Citation

Gaillard R, Durmus B, Hofman A, Mackenbach JP, Steegers EA, Jaddoe VW. Risk factors and outcomes of maternal obesity and excessive weight gain during pregnancy. Obesity (Silver Spring). 2013 May;21(5):1046-55. doi: 10.1002/oby.20088. — View Citation

Gur EB, Ince O, Turan GA, Karadeniz M, Tatar S, Celik E, Yalcin M, Guclu S. Ultrasonographic visceral fat thickness in the first trimester can predict metabolic syndrome and gestational diabetes mellitus. Endocrine. 2014 Nov;47(2):478-84. doi: 10.1007/s12020-013-0154-1. Epub 2014 Jan 23. — View Citation

Haugen M, Brantsæter AL, Winkvist A, Lissner L, Alexander J, Oftedal B, Magnus P, Meltzer HM. Associations of pre-pregnancy body mass index and gestational weight gain with pregnancy outcome and postpartum weight retention: a prospective observational cohort study. BMC Pregnancy Childbirth. 2014 Jun 11;14:201. doi: 10.1186/1471-2393-14-201. — View Citation

Heslehurst N, Ngongalah L, Bigirumurame T, Nguyen G, Odeniyi A, Flynn A, Smith V, Crowe L, Skidmore B, Gaudet L, Simon A, Hayes L. Association between maternal adiposity measures and adverse maternal outcomes of pregnancy: Systematic review and meta-analysis. Obes Rev. 2022 Jul;23(7):e13449. doi: 10.1111/obr.13449. Epub 2022 Apr 25. Review. — View Citation

Lee YS, Biddle S, Chan MF, Cheng A, Cheong M, Chong YS, Foo LL, Lee CH, Lim SC, Ong WS, Pang J, Pasupathy S, Sloan R, Seow M, Soon G, Tan B, Tan TC, Teo SL, Tham KW, van Dam RM, Wang J. Health Promotion Board-Ministry of Health Clinical Practice Guidelines: Obesity. Singapore Med J. 2016 Aug;57(8):472. doi: 10.11622/smedj.2016141. — View Citation

Lukaski HC, Siders WA, Nielsen EJ, Hall CB. Total body water in pregnancy: assessment by using bioelectrical impedance. Am J Clin Nutr. 1994 Mar;59(3):578-85. — View Citation

Nassr AA, Shazly SA, Trinidad MC, El-Nashar SA, Marroquin AM, Brost BC. Body fat index: A novel alternative to body mass index for prediction of gestational diabetes and hypertensive disorders in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:243-248. doi: 10.1016/j.ejogrb.2018.07.001. Epub 2018 Jul 6. — View Citation

Roberts JM, Bodnar LM, Patrick TE, Powers RW. The Role of Obesity in Preeclampsia. Pregnancy Hypertens. 2011 Jan 1;1(1):6-16. doi: 10.1016/j.preghy.2010.10.013. — View Citation

Simon A, Pratt M, Hutton B, Skidmore B, Fakhraei R, Rybak N, Corsi DJ, Walker M, Velez MP, Smith GN, Gaudet LM. Guidelines for the management of pregnant women with obesity: A systematic review. Obes Rev. 2020 Mar;21(3):e12972. doi: 10.1111/obr.12972. Epub 2020 Jan 14. — View Citation

Torloni MR, Betrán AP, Horta BL, Nakamura MU, Atallah AN, Moron AF, Valente O. Prepregnancy BMI and the risk of gestational diabetes: a systematic review of the literature with meta-analysis. Obes Rev. 2009 Mar;10(2):194-203. doi: 10.1111/j.1467-789X.2008.00541.x. Epub 2008 Nov 24. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of gestational diabetes (GDM)	Diagnosis of GDM is made by abnormal glucose tolerance test during pregnancy	Between 24 and 28 weeks of pregnancy
Secondary	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	24 weeks of pregnancy to 10 days postpartum
Secondary	Labor dystocia	Failure to progress in labour resulting in Cesarean section delivery	At time of labour (onset of labour pain to time of delivery)