Gestational Diabetes Follow Up Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Southern California.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Association of American Medical Colleges
Information provided by (Responsible Party):
Penina Segall-Gutierrez, University of Southern California
ClinicalTrials.gov Identifier:
NCT00998595
First received: October 19, 2009
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Diabetes, Gestational
Postpartum Period
Other: Promotora

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Es Mejor Saber: A Proactive Approach to Gestational Diabetes Follow Up

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the fraction of women in each group that attends a referral visit [ Time Frame: within 8 weeks following referral ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: June 2009
Estimated Study Completion Date: October 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Promotora
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)
Other: Promotora
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.
Other Names:
  • Community Health Worker
  • Lay Community Worker
No Intervention: Standard of Care
These subjects receive the routine standard of postpartum care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998595

Locations
United States, California
Los Angeles County + University of Southern California Medical Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Association of American Medical Colleges
Investigators
Principal Investigator: Penina Segall-Gutierrez, M.D., M.Sc. University of Southern California
  More Information

No publications provided

Responsible Party: Penina Segall-Gutierrez, Assistant Professor of Obstetrics and Gynecology and Fmaily medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT00998595     History of Changes
Other Study ID Numbers: MM-1107-09/09 (AAMC-CDC)
Study First Received: October 19, 2009
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Diabetes, Gestational
Postpartum Period
Reproductive Health Services
Health Promotion
Health Personnel

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 28, 2014