Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
935 participants
Study Classification
OBSERVATIONAL
Study Start Date
2012-07-31
Study Completion Date
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1.0 Background
Worldwide, 70 million women in the reproductive age have diabetes or impaired glucose tolerance placing them at risk of complications of hyperglycemia in pregnancy. The global prevalence rates of gestational diabetes mellitus (GDM) vary from between 12% and 14% depending on the population studied.(1,2) The estimated prevalence of GDM has been reported in Western (11.6%) and South Africa (3.8% - 8.8%) but because of the lack of published results and consistency in diagnosis, treatment, and outcomes in Eastern Africa, the extent of the problem of GDM is unknown in Kenya.(2) Estimates from these studies in sub-Saharan Africa (SSA) reveal a widely variable prevalence ranging from 2.4% to 14% with different methodologies and populations of different risk categories. This lack of focused investigation on GDM in Kenya is of concern as preliminary,unpublished data from the Kenyan Global Network Study on birth outcomes suggests that 5.5 % of birth weights in Western Kenya are greater than 4000g, suggesting a substantial potential burden of diabetes mellitus (DM) or GDM in this population.(3) Maternal hyperglycemia during pregancy predisposes the offspring to glucose intolerance in the future by fetal programming. (1,4,5) This vicious cycle can influence and perpetuate the incidence and prevalence of diabetes in any population. Infants born to mothers with diabetes experience double the risk of serious injury at birth, triple the likelihood of caeserean delivery and quadruple the incidence of newborn intensive care unit admissions.(6-8) These maternal, fetal, and neonatal morbidities attributable to diabetes in pregnancy can be prevented with early diagnosis of DM and effective treatment. Within the landscape of care in Western Kenya, pregnancy may be the only time a woman presents for medical care. Therefore, pregnancy is an opportune time to have a receptive audience to screen for possible pregestational diabetes, promote health education, and diagnose glucose intolerance as the woman transitions beyond the postnatal period.
MTRH is the second largest referral hospital in Kenya and serves as a referral center for the whole of Western Kenya. Although access to healthcare is limited in rural areas of Kenya, the Antenatal Clinic at the hospital serves up to 12,000 new mothers annually. Screening for GDM in the antenatal clinic at MTRH is currently limited to a routine urinalysis for glucosuria. Sutherland and colleagues found that 11% of an unselected obstetric population of 1418 women had random glucosuria. However, only 1% of those with glucosuria had an abnormal glucose tolerance test.9 Glucosuria is common in pregnancy and has not been shown to correlate with the diagnosis of GDM.
2.0 Rationale and Specific Aims
The use of a routine urinalysis as a screening strategy for GDM is not consistent with any national or international guidelines.(10-13) There is currently no consensus on the best method to screen for GDM in rural settings lacking infrastructure for venous testing. There are a variety of testing strategies which have been predominantly tested in resource-rich settings and are now used as the standard of care worldwide. Unfortunately, these testing strategies have not been validated or implemented in resource-constrained settings like those existing in Western Kenya.(2) In the United Kingdom, there is a general lack of consensus; most centers employ the 75g glucose tolerance test (Sensitivity 29% and Specificity 96% - these values are for the 75g 2hr postprandial random blood sugar and not the glucose tolerance test), others adopt a two-stage protocol, starting with 50g screen, to be followed, if abnormal, with 75-g glucose tolerance test. Also, according to the WHO criteria and ADA guidelines for GDM diagnosis, a random blood sugar \>11mmol/L (198 mg/dL) or a fasting blood sugar \>7.0mmol/L (126 mg/dL) meets the threshold for diagnosis of GDM.(12) Because of this uncertainty, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) has recently helped provide greater clarity to this issue by issuing suggested guidelines for diagnosing both gestational diabetes and overt diabetes in pregnancy. They recommend the 75gm oral glucose tolerance test and the cutpoints derived from the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study for all patients receiving GDM screening.
As suggested in the IADPSG guidelines and an emerging body of literature, there is growing support for the utilization of the glycosylated hemoglobin (HbA1c) in diagnosing diabetes. (16) Lipska and colleagues report that women and people of African-American ethnicity are more likely to be identified with dysglycemia using HgbA1c than by fasting blood glucose. A notable weakness of this study is that it was performed in adults age 70-79 and thus it is unlcear whether HbAIC can be used as a diagnostic tool in pregnancy. None of the currently available studies evaluating the use of A1c's for GDM have included African women.(17-20) Several studies have also raised concerns about the accuracy of HbA1c in African populations as the HbA1c results tend to be higher than those seen in other populations.(21-23) Because of the various approaches that are currently being proposed by the IADPSG guidelines, there is still considerable debate over the appropriate test to employ as they recommend performing a fasting blood sugar, HbA1c, or random plasma glucose on all women during their first prenatal visit. If a diagnosis of diabetes is not made during this assessment, it is recommended that a 75g oral glucose tolerance test is performed during the 24th to 28th week of the pregnancy to test for GDM. By combining the results of several studies they have also analyzed the additive benefits of combining different strategies. Through this investigation they have concluded that analyzing fasting blood sugars alone enabled them to identify 8.3% of the evaluable population, while the 1 hour glucose measurement identified another 5.7%, and 2 hour glucose measurement identified an additional 2.1%. One major limitation of this investigation, however, was that the cohort did not include patients reflective of the rural SSA population the investigators on this trial serve in Western Kenya. This theme is illustrated throughout this background as there is a deficiency of published results regarding GDM in SSA populations.(10) The IADPSG diagnosis approach also assumes that the vast majority of expectant mothers will have frequent contacts with the healthcare system including early prenatal visits and subsequent visits throughout the pregnancy. This trend is not commonly seen in SSA as a large proportion of expectant mothers deliver at home or have only minimal contact with the healthcare system.(2) Because of these dynamics, there is a clear need to simplify the diagnostic approach for GDM while also assessing the relative utility of each of the testing strategies (ie. random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and HbA1c).
Through this proposal, the investigators hope to take the first step towards addressing GDM in this setting by assessing the relative effectiveness of point of care testing strategies, in comparison to the gold standard approach of using the 75gm oral glucose tolerance test in a representative understudied population.
Worldwide, 70 million women in the reproductive age have diabetes or impaired glucose tolerance placing them at risk of complications of hyperglycemia in pregnancy. The global prevalence rates of gestational diabetes mellitus (GDM) vary from between 12% and 14% depending on the population studied.(1,2) The estimated prevalence of GDM has been reported in Western (11.6%) and South Africa (3.8% - 8.8%) but because of the lack of published results and consistency in diagnosis, treatment, and outcomes in Eastern Africa, the extent of the problem of GDM is unknown in Kenya.(2) Estimates from these studies in sub-Saharan Africa (SSA) reveal a widely variable prevalence ranging from 2.4% to 14% with different methodologies and populations of different risk categories. This lack of focused investigation on GDM in Kenya is of concern as preliminary,unpublished data from the Kenyan Global Network Study on birth outcomes suggests that 5.5 % of birth weights in Western Kenya are greater than 4000g, suggesting a substantial potential burden of diabetes mellitus (DM) or GDM in this population.(3) Maternal hyperglycemia during pregancy predisposes the offspring to glucose intolerance in the future by fetal programming. (1,4,5) This vicious cycle can influence and perpetuate the incidence and prevalence of diabetes in any population. Infants born to mothers with diabetes experience double the risk of serious injury at birth, triple the likelihood of caeserean delivery and quadruple the incidence of newborn intensive care unit admissions.(6-8) These maternal, fetal, and neonatal morbidities attributable to diabetes in pregnancy can be prevented with early diagnosis of DM and effective treatment. Within the landscape of care in Western Kenya, pregnancy may be the only time a woman presents for medical care. Therefore, pregnancy is an opportune time to have a receptive audience to screen for possible pregestational diabetes, promote health education, and diagnose glucose intolerance as the woman transitions beyond the postnatal period.
MTRH is the second largest referral hospital in Kenya and serves as a referral center for the whole of Western Kenya. Although access to healthcare is limited in rural areas of Kenya, the Antenatal Clinic at the hospital serves up to 12,000 new mothers annually. Screening for GDM in the antenatal clinic at MTRH is currently limited to a routine urinalysis for glucosuria. Sutherland and colleagues found that 11% of an unselected obstetric population of 1418 women had random glucosuria. However, only 1% of those with glucosuria had an abnormal glucose tolerance test.9 Glucosuria is common in pregnancy and has not been shown to correlate with the diagnosis of GDM.
2.0 Rationale and Specific Aims
The use of a routine urinalysis as a screening strategy for GDM is not consistent with any national or international guidelines.(10-13) There is currently no consensus on the best method to screen for GDM in rural settings lacking infrastructure for venous testing. There are a variety of testing strategies which have been predominantly tested in resource-rich settings and are now used as the standard of care worldwide. Unfortunately, these testing strategies have not been validated or implemented in resource-constrained settings like those existing in Western Kenya.(2) In the United Kingdom, there is a general lack of consensus; most centers employ the 75g glucose tolerance test (Sensitivity 29% and Specificity 96% - these values are for the 75g 2hr postprandial random blood sugar and not the glucose tolerance test), others adopt a two-stage protocol, starting with 50g screen, to be followed, if abnormal, with 75-g glucose tolerance test. Also, according to the WHO criteria and ADA guidelines for GDM diagnosis, a random blood sugar \>11mmol/L (198 mg/dL) or a fasting blood sugar \>7.0mmol/L (126 mg/dL) meets the threshold for diagnosis of GDM.(12) Because of this uncertainty, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) has recently helped provide greater clarity to this issue by issuing suggested guidelines for diagnosing both gestational diabetes and overt diabetes in pregnancy. They recommend the 75gm oral glucose tolerance test and the cutpoints derived from the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study for all patients receiving GDM screening.
As suggested in the IADPSG guidelines and an emerging body of literature, there is growing support for the utilization of the glycosylated hemoglobin (HbA1c) in diagnosing diabetes. (16) Lipska and colleagues report that women and people of African-American ethnicity are more likely to be identified with dysglycemia using HgbA1c than by fasting blood glucose. A notable weakness of this study is that it was performed in adults age 70-79 and thus it is unlcear whether HbAIC can be used as a diagnostic tool in pregnancy. None of the currently available studies evaluating the use of A1c's for GDM have included African women.(17-20) Several studies have also raised concerns about the accuracy of HbA1c in African populations as the HbA1c results tend to be higher than those seen in other populations.(21-23) Because of the various approaches that are currently being proposed by the IADPSG guidelines, there is still considerable debate over the appropriate test to employ as they recommend performing a fasting blood sugar, HbA1c, or random plasma glucose on all women during their first prenatal visit. If a diagnosis of diabetes is not made during this assessment, it is recommended that a 75g oral glucose tolerance test is performed during the 24th to 28th week of the pregnancy to test for GDM. By combining the results of several studies they have also analyzed the additive benefits of combining different strategies. Through this investigation they have concluded that analyzing fasting blood sugars alone enabled them to identify 8.3% of the evaluable population, while the 1 hour glucose measurement identified another 5.7%, and 2 hour glucose measurement identified an additional 2.1%. One major limitation of this investigation, however, was that the cohort did not include patients reflective of the rural SSA population the investigators on this trial serve in Western Kenya. This theme is illustrated throughout this background as there is a deficiency of published results regarding GDM in SSA populations.(10) The IADPSG diagnosis approach also assumes that the vast majority of expectant mothers will have frequent contacts with the healthcare system including early prenatal visits and subsequent visits throughout the pregnancy. This trend is not commonly seen in SSA as a large proportion of expectant mothers deliver at home or have only minimal contact with the healthcare system.(2) Because of these dynamics, there is a clear need to simplify the diagnostic approach for GDM while also assessing the relative utility of each of the testing strategies (ie. random blood sugar, fasting blood sugar, 1 hr/2hr glucose tolerance test, and HbA1c).
Through this proposal, the investigators hope to take the first step towards addressing GDM in this setting by assessing the relative effectiveness of point of care testing strategies, in comparison to the gold standard approach of using the 75gm oral glucose tolerance test in a representative understudied population.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Diabetes, Gestational
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Point of care and venous screening
Intervention Type
PROCEDURE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Point of care and venous screening
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All pregnant women at 24-32 weeks gestation
* Singleton pregnancies
* Singleton pregnancies
Exclusion Criteria
* 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
* Participants \< 18 years of age
* On medications that affect glucose control
* Unable to complete the study protocol
* Unable to provide informed consent
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Moi University
OTHER
Sponsor Role
collaborator
Purdue University
OTHER
Sponsor Role
collaborator
Indiana Clinical and Translational Sciences Institute
OTHER
Sponsor Role
collaborator
Indiana University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sonak Pastakia
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sonak D Pastakia, PharmD, MPH
Role: PRINCIPAL_INVESTIGATOR
Purdue University, Moi University, Indiana University
References
Explore related publications, articles, or registry entries linked to this study.
Ryan EA. Diagnosing gestational diabetes. Diabetologia. 2011 Mar;54(3):480-6. doi: 10.1007/s00125-010-2005-4. Epub 2011 Jan 4.
Reference Type
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.
Reference Type
BACKGROUND
Liechty E. (personal communication). Global Research Network Study Kenya.
Reference Type
BACKGROUND
International Diabetes Federation. Global Guideline on Pregnancy and Diabetes. Brussels: International Diabetes Federation, 2009.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Ross G. Gestational diabetes. Aust Fam Physician. 2006 Jun;35(6):392-6.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1205008671
Identifier Type: -
Identifier Source: org_study_id