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Gestational Diabetes Follow Up Study

Primary Purpose

Diabetes, Gestational, Postpartum Period

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Promotora
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes, Gestational focused on measuring Diabetes, Gestational, Postpartum Period, Reproductive Health Services, Health Promotion, Health Personnel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Los Angeles County + University of Southern California Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Promotora

Standard of Care

Arm Description

This group receives additional education and proactive follow-up by removing barriers to already existing services and reminders by a lay community health workers (Promotora)

These subjects receive the routine standard of postpartum care

Outcomes

Primary Outcome Measures

the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.

Secondary Outcome Measures

the fraction of women in each group that attends a referral visit

Full Information

First Posted
October 19, 2009
Last Updated
March 29, 2017
Sponsor
University of Southern California
Collaborators
Centers for Disease Control and Prevention, Association of American Medical Colleges
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1. Study Identification

Unique Protocol Identification Number
NCT00998595
Brief Title
Gestational Diabetes Follow Up Study
Official Title
Es Mejor Saber: A Proactive Approach to Gestational Diabetes Follow Up
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Centers for Disease Control and Prevention, Association of American Medical Colleges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational, Postpartum Period
Keywords
Diabetes, Gestational, Postpartum Period, Reproductive Health Services, Health Promotion, Health Personnel

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Promotora
Arm Type
Experimental
Arm Description
This group receives additional education and proactive follow-up by removing barriers to already existing services and reminders by a lay community health workers (Promotora)
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
These subjects receive the routine standard of postpartum care
Intervention Type
Other
Intervention Name(s)
Promotora
Other Intervention Name(s)
Community Health Worker, Lay Community Worker
Intervention Description
The Promotora will deliver education regarding postpartum follow-up and steps to take to decrease the risk for developing type 2 diabetes. The Promotora will clarify misperceptions and answer questions related to risk of developing diabetes and contraception. If the subject has barriers to accessing care with transportation or childcare, she will help the subjects to access existing resources. The Promotora will give the subject her contact information and will also contact the subject to remind her of her appointments and reschedule if she missed an appointment.
Primary Outcome Measure Information:
Title
the fraction of each group that participates in postpartum follow up and glucose tolerance testing 4-12 weeks post partum.
Time Frame
4-12 weeks post partum
Secondary Outcome Measure Information:
Title
the fraction of women in each group that attends a referral visit
Time Frame
within 8 weeks following referral

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penina Segall-Gutierrez, M.D., M.Sc.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County + University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Gestational Diabetes Follow Up Study

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