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Trial record 5 of 5 for:    15951574 [PUBMED-IDS]

Diagnosis of Gestational Diabetes in Eldoret, Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02978807
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
Moi University
Purdue University
Indiana Clinical and Translational Sciences Institute
Information provided by (Responsible Party):
Sonak Pastakia, Purdue University

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?

Condition or disease Intervention/treatment
Diabetes, Gestational Procedure: Point of care and venous screening

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 935 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishing the Prevalance and Accuracy of Different Diagnostic Techniques for Gestational Diabetes in the Resource-constrained Setting of Eldoret, Kenya
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Prevalence of Gestational Diabetes via venous 75 gm oral glucose tolerance test [ Time Frame: Measured between 24-32 weeks of pregnancy ]
    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.


Secondary Outcome Measures :
  1. Specificity, Sensitivity, positive predictive value, and negative predictive value of alternative point of care screening strategies [ Time Frame: Measured between 24-32 weeks of pregnancy ]

    On day 1, a capillary blood sample was obtained to perform a point of care (POC) random blood glucose test and glycated hemoglobin. A 50gm glucose load was then administered capillary blood samples were collected after 1-hr All participants were then expected to return the next day (or within 1 week for those unable to follow-up immediately) after having fasted overnight for ≥ 8 hours.

    Day 2 testing procedures included recommended IADPSG testing alongside the analogous POC tests. Capillary and venous blood samples for measurement of POC and plasma fasting glucose, venous HbA1c and a complete blood count with differential was performed. A 75gm glucose load was then administered with capillary and venous blood samples collected at 1-hr and 2-hrs for measurement of POC and plasma glucose levels.

    The sensitivity, specificity, NPV and PPV of each screening strategy was determined using 2 by 2 matrices with the IADPSG criteria for the venous 75gm OGTT as the gold standard reference.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion criteria:

  • All pregnant women at 24-32 weeks gestation
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978807


Sponsors and Collaborators
Indiana University
Moi University
Purdue University
Indiana Clinical and Translational Sciences Institute
Investigators
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Principal Investigator: Sonak D Pastakia, PharmD, MPH Purdue University, Moi University, Indiana University

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
This is the study protocol guiding the study

Publications:
Liechty E. (personal communication). Global Research Network Study Kenya.
International Diabetes Federation. Global Guideline on Pregnancy and Diabetes. Brussels: International Diabetes Federation, 2009.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sonak Pastakia, Associate Professor, Purdue University
ClinicalTrials.gov Identifier: NCT02978807     History of Changes
Other Study ID Numbers: 1205008671
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no need to send out IPD and only de-identified data was analyzed
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications