Clinical trial NCT00998595: Gestational Diabetes Follow Up Study
Official title: Es Mejor Saber: A Proactive Approach to Gestational Diabetes Follow Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes, Gestational
Postpartum Period
Keywords: Diabetes, Gestational
Postpartum Period
Reproductive Health Services
Health Promotion
Health Personnel
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Association of American Medical Colleges
First posted: 2009-10-20
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary hypothesis underlying this proposal is that the introduction of a Promotora to provide education and proactive follow-up to women with GDM will increase compliance with postpartum glucose tolerance testing. The secondary hypothesis is that the Promotora will improve participation in referral visits for diabetes or preventive care. We will develop the promotora program and begin pilot implementation.

Detailed description: As Los Angeles County + University of Southern California Medical Center (LAC+USC) serves an indigent Latino population at increased risk for developing Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus (GDM) complicated 13% of deliveries at LAC+USC between 2006-2007. While over 50% of GDM patients will develop overt diabetes mellitus within a decade of the incident pregnancy, less than half of these patients ever return for even one post-partum follow up visit at this institution (45%). Lifestyle Interventions and medications have been shown to delay or prevent the onset of T2DM. However, prevention is only possible if patients follow-up and individual risk assessment is made. While identifying the 2-hour glucose tolerance test as the appropriate postpartum screening technique for patients with a history of GDM, the Fifth International Workshop-Conference on Gestational Diabetes Mellitus did not identify strategies to improve follow up among this patient population. Promotoras (bi-lingual, bi-cultural lay community health workers representative of the Latino community base) have been successful in improving follow up for other areas of diabetes and women's preventive services but have not been studies in the context of GDM. We will develop the Es Mejor Saber training materials and program and pilot a randomized control trial (RCT),a total 216 subjects completing a GDM affected pregnancy will be randomized on the postpartum ward to the standard-of-care versus proactive follow-up with a Promotora. The Promotora will provide education, address barriers to follow-up, remind subjects of their appointments, and call them to reschedule if they miss appointments. In the first phase of the study, these appointments will include the OGTT and the initial postpartum visit. In the second phase, these visits will include referrals to internal medicine (for those diagnosed with T2DM) or nutrition counseling (for those found not to have diabetes). The primary hypothesis underlying this proposal is that the introduction of a Promotora providing education and pro-active follow-up into postpartum GDM management will result improve post-partum follow-up for screening, treatment, and preventive services when compared with the standard of care.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with diabetes for the first time during the most recent pregnancy
* Completed pregnancy \>20 weeks duration
* Has access to a telephone
* Is willing to be contacted by the Promotora
* Is willing to follow-up at LAC+USC for postpartum visit
* Able to give informed consent
* Age ≥18 years
* Residence within 60 miles of LAC+USC
* ON INPATIENT WARD AT LAC+USC AT TIME OF RECRUITMENT

Exclusion Criteria:

* Diagnosis of diabetes prior to most recent pregnancy (pre-gestational diabetes)
* Current ICU admission during delivery hospitalization that would interfere with recruitment and participation in the study
* Currently residing in jail or inpatient psychiatric facility
* Postpartum day #1-2, any Fasting Blood Glucose ≥126mg/dL or random BG≥200mg/dL
* Plans postpartum follow-up at non-participating postpartum clinic location

A Medical Record Abstraction Only Cohort is a third group of patients who live within 60 miles of LAC+USC, plan to obtain postpartum care at LAC+USC, and completed a GDM affected pregnancy but refuse participation or do not qualify based on the following: elevated glucose consistent with diagnosis of T2DM or maintained on insulin postpartum, incarceration or resides in inpatient psychiatric facility, age \<18, no telephone, unwilling to be contacted by Promotora, or are unable to consent for participation.This cohort can not be enrolled in the study but data is abstracted from the medical records to compare demographics and follow up in our study to all patients with GDM who deliver at LAC+USC.

Primary outcomes:
measure: the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.
timeFrame: 4-12 weeks post partum
Secondary outcomes:
measure: the fraction of women in each group that attends a referral visit
timeFrame: within 8 weeks following referral
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County + University of Southern California Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Penina Segall-Gutierrez, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: