NCT02013557

Brief Summary

Purpose: The purpose of this study is to see whether a text-message reminder system will increase the number of women who complete their diabetes screening after delivery. Study Design: Prospective randomized control trial Hypothesis: Gestational diabetics will be significantly more likely to follow up with their postpartum screening for diabetes if they receive text-message reminders to set up their lab appointment compared to those who receive usual care.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

December 11, 2013

Last Update Submit

January 5, 2016

Conditions

Keywords

Gestational DiabetesPostpartum screeningText-messages75-g oral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients that receive the 2-hour 75-g oral glucose tolerance test

    Within six months of their delivery date

Secondary Outcomes (1)

  • Percentage of patients that receive any type of postpartum diabetes screening

    Within six months of their delivery date

Study Arms (2)

Intervention Group

EXPERIMENTAL

Women in the intervention group will receive a test text-message reminder at the time of enrollment. They will then receive a text-reminder to schedule their oral glucose tolerance test at 6 weeks postpartum, with further reminders at 3 months and 6 months if they have not completed their testing.

Behavioral: Text-message reminder

Control group

NO INTERVENTION

This arm will only receive the test text-message reminder at the time of enrollment. Otherwise they will receive usual postpartum care.

Interventions

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women diagnosed with gestational diabetes (GDM) based on a 100-g, 3-hour glucose tolerance test with 2 or more abnormal values according to the Carpenter-Coustan criteria OR Women with a 50-g, 1-hour loading test \>200mg/dl.
  • Diagnosed with GDM at least at 24 weeks gestation or later
  • Access to a personal mobile phone with text-messaging capabilities.
  • Age 18 or greater
  • Able to provide written and informed consent in English or Spanish language

You may not qualify if:

  • Women that were ever diagnosed with diabetes outside of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Judette Louis, MD

    University of South Florida Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR
  • Angela Gonzalez, MD

    University of South Florida Department of Obstetrics and Gynecology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2013

First Posted

December 17, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations