GDM Post Partum Screening

NCT03946631 | Terminated

• 1 other identifier: GDM 2019 iris 01-18-0028
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Immediate postpartum screening for diabetes mellitus in women with gestational diabetes The objective of this study is to determine if screening for type 2 diabetes can be done 24 hours after delivery, versus 6-12 weeks postpartum, in recently delivered women having been diagnosed with gestational diabetes requiring medication therapy in the antecedent pregnancy.

Conditions

Diabetes; Gestational Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Sensitivity of early postpartum overt diabetes screening by 2-hour glucose tolerance testing in postpartum women.

  We will compare the sensitivity of a 2-hour oral glucose tolerance test (2HR OGTT) for the detection of overt diabetes when performed within 48 hours of delivery ("early") among postpartum women previously diagnosed with gestational diabetes requiring treatment. The "early" 2HR OGTT result will be compared to the current standard of care of a 2HR OGTT performed at 6-12 weeks postpartum.

  24-48 hours postpartum verses 6-12 weeks postpartum.

Study Arms (1)

Blood Glucose Test - 2hour GTT

Only one arm: intervention group. The intervention is fasting 2 hour glucose tolerance test in the immediate postpartum period. The screening test consists of fingerstick blood glucose testing after a glucose drink. First, a fasting blood glucose finger stick will be performed. Second, the glucose drink is orally ingested containing 75g glucose. The drink is to be orally ingested over 60 seconds. Lastly, fingerstick blood glucose testing is completed at 1 hour post drink and 2 hours post drink.

Diagnostic Test: 2 hour glucose tolerance test using 75g glucose drink

Interventions

2 hour glucose tolerance test using 75g glucose drink DIAGNOSTIC_TEST

intervention is a 2 hour glucose tolerance test. Involves oral intake of a 75g glucose drink followed by using point of care testing. Glucose drink is taken after at least 6 hours of fasting. Fingerstick blood glucose testing done at three time points: fasting, one hour post drink and two hours post drink.

Also known as: fingerstick testing

Blood Glucose Test - 2hour GTT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: pregnant females with current diagnosis of type 2 DM or gestational diabetes
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks, \>18 years-old (yo), English speaking

You may qualify if:

• Pregnant, or recently postpartum, women with the diagnosis of GDM requiring medication therapy after 20 weeks,
• \>18 years-old (yo)yo,
• English speaking.

You may not qualify if:

• have pre-existing type 2 DM,
• did not require anti-hyperglycemic medication therapy (GDMA1),
• early onset GDM (\<20 weeks).
• do not speak English .

Sponsors & Collaborators

• Pediatrix: lead
• Banner University Medical Center: collaborator

Study Sites (1)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (8)

• Gobl CS, Bozkurt L, Prikoszovich T, Winzer C, Pacini G, Kautzky-Willer A. Early possible risk factors for overt diabetes after gestational diabetes mellitus. Obstet Gynecol. 2011 Jul;118(1):71-78. doi: 10.1097/AOG.0b013e318220e18f.

  PMID: 21691165 BACKGROUND

• Su X, Zhang Z, Qu X, Tian Y, Zhang G. Hemoglobin A1c for diagnosis of postpartum abnormal glucose tolerance among women with gestational diabetes mellitus: diagnostic meta-analysis. PLoS One. 2014 Jul 11;9(7):e102144. doi: 10.1371/journal.pone.0102144. eCollection 2014.

  PMID: 25014072 BACKGROUND

• Mendez-Figueroa H, Daley J, Breault P, Lopes VV, Paine V, Goldman D, Francis MJ, Delgado B, Coustan DR. Impact of an intensive follow-up program on the postpartum glucose tolerance testing rate. Arch Gynecol Obstet. 2014 Jun;289(6):1177-83. doi: 10.1007/s00404-014-3157-0. Epub 2014 Jan 31.

  PMID: 24481876 BACKGROUND

• Kjos SL, Peters RK, Xiang A, Henry OA, Montoro M, Buchanan TA. Predicting future diabetes in Latino women with gestational diabetes. Utility of early postpartum glucose tolerance testing. Diabetes. 1995 May;44(5):586-91. doi: 10.2337/diab.44.5.586.

  PMID: 7729620 BACKGROUND

• 5. Biljok VR, Bozicevic S, Lovrencic MV, Car N. Performance of the StatStrip Glucose Meter in Inpatient Management of Diabetes Mellitus. Diabetologia Croatica 2010; 39-3:105-109.

  BACKGROUND

• Werner EF, Has P, Tarabulsi G, Lee J, Satin A. Early Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2016 Aug;33(10):966-71. doi: 10.1055/s-0036-1583193. Epub 2016 Apr 27.

  PMID: 27120481 BACKGROUND

• Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available.

  PMID: 28910846 BACKGROUND

• Vucic Lovrencic M, Radisic Biljak V, Bozicevic S, Pape-Medvidovic E, Ljubic S. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes. Int J Endocrinol. 2013;2013:206309. doi: 10.1155/2013/206309. Epub 2013 Dec 8.

  PMID: 24382960 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fingerstick blood glucose test

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes, Gestational; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Laura Wilkes

  Banner University Medical Center

  STUDY DIRECTOR

• Kisti Fuller, MD

  Phoenix Perinatal Associates, Mednax

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 10, 2019
• Study Start: August 20, 2019
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)