Gestational Diabetes Follow Up Study

NCT00998595 | Completed

• 1 other identifier: MM-1107-09/09 (AAMC-CDC)
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes, Gestational; Postpartum Period

Keywords

Diabetes, Gestational; Postpartum Period; Reproductive Health Services; Health Promotion; Health Personnel

Outcome Measures

Primary Outcomes (1)

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

  4-12 weeks post partum

Secondary Outcomes (1)

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

  within 8 weeks following referral

Study Arms (2)

Promotora

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

These subjects receive the routine standard of postpartum care

Interventions

Promotora OTHER

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.

Also known as: Community Health Worker, Lay Community Worker

Promotora

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Centers for Disease Control and Prevention: collaborator
• Association of American Medical Colleges: collaborator

Study Sites (1)

Los Angeles County + University of Southern California Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Zaman A, Ovalle B, Reyes C, Segall-Gutierrez P. Enhanced Participation in Diabetes Screening and Care After Gestational Diabetes Through Community Health Workers: Results from the Es Mejor Saber Randomized Controlled Trial. J Immigr Minor Health. 2024 Feb;26(1):45-53. doi: 10.1007/s10903-023-01547-5. Epub 2023 Oct 25.

  PMID: 37878217 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Penina Segall-Gutierrez, M.D., M.Sc.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 31, 2017

Record last verified: 2011-09

Locations

US (1)