Clinical trial NCT03946631: GDM Post Partum Screening
Official title: Immediate Postpartum Screening for Diabetes Mellitus in Women With Gestational Diabetes.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Gestational Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: Banner University Medical Center
First posted: 2019-05-10
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Detailed description: 1 Overview The purpose of the project is to determine if screening for diabetes mellitus, in women with gestational diabetes, can be done 24 hours postpartum versus 6-12 weeks postpartum.

Primary Objective: To compare the results from screening for type 2 diabetes 24 hours postpartum versus 6-12 weeks postpartum.

Design and Project Type Prospective cohort study. Women diagnosed with gestational diabetes and receiving anti-hyperglycemic medication therapy will have testing for type 2 DM done 24 hours after delivery. They will also have routine screening for type 2 DM done at 6-12 weeks postpartum.

Description of Intervention The intervention is early screening for type 2 DM which involves oral intake of a 75-- gram (g) glucose drink and subsequent measurement of fasting, 1- hour, and 2- hour postprandial point of care fingerstick s for blood glucose measurement.

Instruments Fingerstick testing will be done with StatStrip Glucose Hospital Meter (Nova Biomedical). This device is used routinely throughout the hospital and has been validated for use in all patients, including the critically ill. Using point of care testing will allow for accurate results with less pain for the patient, as compared to (fingerstick versus venipuncture).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Sensitivity of early postpartum overt diabetes screening by 2-hour glucose tolerance testing in postpartum women.
timeFrame: 24-48 hours postpartum verses 6-12 weeks postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Laura Wilkes
role: STUDY_DIRECTOR
affiliation: Phoenix Perinatal Associates, Mednax
name: Kisti Fuller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.