Body Fat Index for Obstetric Risk Stratification

NCT05533996 | Unknown

• 1 other identifier: MCOG-RCT02
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes; Pre-Eclampsia; Labour Dystocia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnosis of pre-eclampsia Incidence of Cesarean section

  24 weeks of pregnancy to 10 days postpartum

• Labor dystocia

  At time of labour (onset of labour pain to time of delivery)

Study Arms (1)

Pregnant women prior to 14 weeks

OTHER

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

Interventions

ultrasound DIAGNOSTIC_TEST

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

Pregnant women prior to 14 weeks

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women prior to 14 weeks

You may not qualify if:

• Known pre-gestational diabetes

Sponsors & Collaborators

• Assiut University: lead
• Baylor College of Medicine: collaborator
• Middle-Eastern College of Obstetricians and Gynecologists: collaborator

Related Publications (15)

• 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.

  PMID: 23784909 BACKGROUND

• Haugen M, Brantsaeter 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.

  PMID: 24917037 BACKGROUND

• 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.

  PMID: 31943650 BACKGROUND

• 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. No abstract available.

  PMID: 27550044 BACKGROUND

• ACOG Practice Bulletin No 156: Obesity in Pregnancy. Obstet Gynecol. 2015 Dec;126(6):e112-e126. doi: 10.1097/AOG.0000000000001211. No abstract available.

  PMID: 26595582 BACKGROUND

• 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.

  PMID: 19939755 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 35467075 BACKGROUND

• Torloni MR, Betran 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.

  PMID: 19055539 BACKGROUND

• 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.

  PMID: 21532964 BACKGROUND

• 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.

  PMID: 19713286 BACKGROUND

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  PMID: 24452873 BACKGROUND

• 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. doi: 10.1093/ajcn/59.3.578.

  PMID: 8116533 BACKGROUND

• 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. doi: 10.1093/ajcn/87.5.1212.

  PMID: 18469241 BACKGROUND

• 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.

  PMID: 30014931 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Pre-Eclampsia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sherif Shazly, MSc

  The Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Ahmed Nassr, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sherif shazly, MSc

CONTACT

administration@mogge-obgyn.com

Mohamed Abuelazm

CONTACT

mohamed.abuelazm.mogge@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: March 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share