Gestational Diabetes Clinical Trial
— BFIorsOfficial title:
Body Fat Index as a Novel Sonographic Tool to Predict High Risk Pregnancy (BFiORS Trial)
Verified date | October 2022 |
Source | Assiut University |
Contact | sherif shazly, MSc |
administration[@]mogge-obgyn.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assiut University | Baylor College of Medicine, Middle-Eastern College of Obstetricians and Gynecologists |
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
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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
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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
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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
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* Note: There are 15 references in all — Click here to view all references
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) |
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