Diagnosis of Gestational Diabetes in Eldoret, Kenya

NCT02978807 | Completed

• 1 other identifier: 1205008671
• Study Type: observational
• Target: 935
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the most appropriate and effective approach for the diagnosis of gestational diabetes mellitus (GDM) among pregnant women receiving focused antenatal care at Moi Teaching and Referral Hospital (MTRH). This will be done through performing a random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and HbA1c on all participants who meet eligibility criteria and provide written, informed consent. The specific research question is: what is the most appropriate screening and diagnostic strategy for patients receiving antenatal care at MTRH?

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Prevalence of Gestational Diabetes via venous 75 gm oral glucose tolerance test

  We determined prevalence of gestational diabetes by utilizing the gold standard testing strategy recommended by IADPSG. This includes the completion of a venous fasting blood sugar, provision of a 75 gm glucose, 1 hr post prandial venous glucose assessment, 2 hour post prandial venous glucose assessment. We recruited 935 patients of which 616 patients returned for the venous testing and completed these tests.

  Measured between 24-32 weeks of pregnancy

Secondary Outcomes (1)

• Specificity, Sensitivity, positive predictive value, and negative predictive value of alternative point of care screening strategies

  Measured between 24-32 weeks of pregnancy

Study Arms (1)

Pregnant women between 24 to 32 weeks

Pregnant women with a singleton pregnancy who presented to care between 24 -32 weeks of their pregnancy were included in this study. All patients enrolled in the study will receive a random point of care blood sugar, point of care and venous fasting blood sugar, point of care and venous 1 hr/2hr glucose tolerance test, and point of care and venous HbA1c.

Procedure: Point of care and venous screening

Interventions

Point of care and venous screening PROCEDURE

Pregnant women between 24 to 32 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective cohort study that will be conducted at Moi Teaching and Referral Hospital, Mediheal Hospital, and Uashin Gishu District Hospital Antenatal Clinic in western Kenya

You may qualify if:

• All pregnant women at 24-32 weeks gestation
• Singleton pregnancies

You may not qualify if:

• Pre-existing diagnosis of diabetes
• Participants \< 18 years of age
• On medications that affect glucose control
• Unable to complete the study protocol
• Unable to provide informed consent

Sponsors & Collaborators

• Indiana University: lead
• Moi University: collaborator
• Purdue University: collaborator
• Indiana Clinical and Translational Sciences Institute: collaborator

Related Publications (24)

• Ryan EA. Diagnosing gestational diabetes. Diabetologia. 2011 Mar;54(3):480-6. doi: 10.1007/s00125-010-2005-4. Epub 2011 Jan 4.

  PMID: 21203743 BACKGROUND

• Zeck W, McIntyre HD. Gestational diabetes in rural East Africa: a call to action. J Womens Health (Larchmt). 2008 Apr;17(3):403-11. doi: 10.1089/jwh.2007.0380.

  PMID: 18328010 BACKGROUND

• Liechty E. (personal communication). Global Research Network Study Kenya.

  BACKGROUND

• International Diabetes Federation. Global Guideline on Pregnancy and Diabetes. Brussels: International Diabetes Federation, 2009.

  BACKGROUND

• Mbanya JC, Motala AA, Sobngwi E, Assah FK, Enoru ST. Diabetes in sub-Saharan Africa. Lancet. 2010 Jun 26;375(9733):2254-66. doi: 10.1016/S0140-6736(10)60550-8.

  PMID: 20609971 BACKGROUND

• Berger H, Crane J, Farine D, Armson A, De La Ronde S, Keenan-Lindsay L, Leduc L, Reid G, Van Aerde J; Maternal-Fetal Medicine Committee; Executive and Coundil fo the Society of Obstetricians and Gynaecologists of Canada. RETIRED: Screening for gestational diabetes mellitus. J Obstet Gynaecol Can. 2002 Nov;24(11):894-912. doi: 10.1016/s1701-2163(16)31047-7. English, French.

  PMID: 12417905 BACKGROUND

• Boney CM, Verma A, Tucker R, Vohr BR. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005 Mar;115(3):e290-6. doi: 10.1542/peds.2004-1808.

  PMID: 15741354 BACKGROUND

• HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.

  PMID: 18463375 BACKGROUND

• Jovanovic-Peterson L, Bevier W, Peterson CM. The Santa Barbara County Health Care Services program: birth weight change concomitant with screening for and treatment of glucose-intolerance of pregnancy: a potential cost-effective intervention? Am J Perinatol. 1997 Apr;14(4):221-8. doi: 10.1055/s-2007-994131.

  PMID: 9259932 BACKGROUND

• Mamabolo RL, Alberts M, Levitt NS, Delemarre-van de Waal HA, Steyn NP. Prevalence of gestational diabetes mellitus and the effect of weight on measures of insulin secretion and insulin resistance in third-trimester pregnant rural women residing in the Central Region of Limpopo Province, South Africa. Diabet Med. 2007 Mar;24(3):233-9. doi: 10.1111/j.1464-5491.2006.02073.x.

  PMID: 17263763 BACKGROUND

• Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.

  PMID: 15951574 BACKGROUND

• Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.

  PMID: 19797280 BACKGROUND

• Sutherland HW, Stowers JM, McKenzie C. Simplifying the clinical problem of glycosuria in pregnancy. Lancet. 1970 May 23;1(7656):1069-71. doi: 10.1016/s0140-6736(70)92751-0. No abstract available.

  PMID: 4191957 BACKGROUND

• International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.

  PMID: 20190296 BACKGROUND

• Ross G. Gestational diabetes. Aust Fam Physician. 2006 Jun;35(6):392-6.

  PMID: 16751853 BACKGROUND

• American Diabetes Association. Gestational diabetes mellitus. Diabetes Care. 2004 Jan;27 Suppl 1:S88-90. doi: 10.2337/diacare.27.2007.s88. No abstract available.

  PMID: 14693936 BACKGROUND

• Lipska KJ, De Rekeneire N, Van Ness PH, Johnson KC, Kanaya A, Koster A, Strotmeyer ES, Goodpaster BH, Harris T, Gill TM, Inzucchi SE. Identifying dysglycemic states in older adults: implications of the emerging use of hemoglobin A1c. J Clin Endocrinol Metab. 2010 Dec;95(12):5289-95. doi: 10.1210/jc.2010-1171. Epub 2010 Sep 22.

  PMID: 20861123 BACKGROUND

• Kirk JK, D'Agostino RB Jr, Bell RA, Passmore LV, Bonds DE, Karter AJ, Narayan KM. Disparities in HbA1c levels between African-American and non-Hispanic white adults with diabetes: a meta-analysis. Diabetes Care. 2006 Sep;29(9):2130-6. doi: 10.2337/dc05-1973.

  PMID: 16936167 BACKGROUND

• Holcomb WL Jr, Mostello DJ, Leguizamon GF. African-American women have higher initial HbA1c levels in diabetic pregnancy. Diabetes Care. 2001 Feb;24(2):280-3. doi: 10.2337/diacare.24.2.280.

  PMID: 11213879 BACKGROUND

• Katon J, Williams MA, Reiber G, Miller E. Antepartum A1C, maternal diabetes outcomes, and selected offspring outcomes: an epidemiological review. Paediatr Perinat Epidemiol. 2011 May;25(3):265-76. doi: 10.1111/j.1365-3016.2011.01195.x. Epub 2011 Mar 21.

  PMID: 21470266 BACKGROUND

• Sapienza AD, Francisco RP, Trindade TC, Zugaib M. Factors predicting the need for insulin therapy in patients with gestational diabetes mellitus. Diabetes Res Clin Pract. 2010 Apr;88(1):81-6. doi: 10.1016/j.diabres.2009.12.023. Epub 2010 Jan 13.

  PMID: 20071050 BACKGROUND

• Brown CJ, Dawson A, Dodds R, Gamsu H, Gillmer M, Hall M, Hounsome B, Knopfler A, Ostler J, Peacock I, Rothman D, Steel J. Report of the Pregnancy and Neonatal Care Group. Diabet Med. 1996 Sep;13(9 Suppl 4):S43-53. No abstract available.

  PMID: 8894455 BACKGROUND

• Maegawa Y, Sugiyama T, Kusaka H, Mitao M, Toyoda N. Screening tests for gestational diabetes in Japan in the 1st and 2nd trimester of pregnancy. Diabetes Res Clin Pract. 2003 Oct;62(1):47-53. doi: 10.1016/s0168-8227(03)00146-3.

  PMID: 14581157 BACKGROUND

• Pastakia SD, Njuguna B, Onyango BA, Washington S, Christoffersen-Deb A, Kosgei WK, Saravanan P. Prevalence of gestational diabetes mellitus based on various screening strategies in western Kenya: a prospective comparison of point of care diagnostic methods. BMC Pregnancy Childbirth. 2017 Jul 14;17(1):226. doi: 10.1186/s12884-017-1415-4.

  PMID: 28705184 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Point-of-Care Systems

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

Intervention Hierarchy (Ancestors)

Hospital Information Systems; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Management Information Systems; Patient Care Management

Study Officials

• Sonak D Pastakia, PharmD, MPH

  Purdue University, Moi University, Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 1, 2016
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share