Preventing T2DM After GDM With Immediate Postpartum Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
able and willing to provide informed consent
ability to complete immediate in hospital postpartum glucose testing
Disqualifiers
known diagnosis of pre-existing pre-gestational diabetes in pregnancy
inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
systemic steroid use
Trial design
Design model
Parallel
Treatments tested in this trial
Glucose tolerance test (2 hour)
Diagnostic testEarly testing with the 2 hour glucose tolerance test will occur during their inpatient postpartum hospitalization.
Active Comparator
Other interventionSubjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Early Postpartum GDM ScreeningExperimental treatment 1 intervention
Group B: Standard of Care Postpartum ScreeningActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Detection of Type 2 Diabetes Mellitus
Detection of Type 2 Diabetes Mellitus by 2 hour oral glucose tolerance test
Time frame
At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)2
Glycemic Outcomes--Hemoglobin A1c
Serum blood measurement of hemoglobin A1c
Time frame
at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)Secondary outcomes
1
Patient Satisfaction
Participant satisfaction will be assessed using the validated survey, the Patient Satisfaction Survey. The survey was developed in 1979 and has been used to assess patient satisfaction with research participation based on 8 simple questions. It has not been used in a randomized trial in an obstetric population but has been validated in other clinical populations
Time frame
At postpartum visit (6 weeks after delivery)2
Patient Recruitment
The investigators will examine the total number of subjects that were approached and the reasons for ineligibility and non-participation.
Time frame
at time of randomization (postpartum day 1)3
Patient Retention
The investigators will record reasons for failure to complete in hospital diabetes screening and treatment.
Time frame
At postpartum visit (6 weeks after delivery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov