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TerminatedNCT02013557Updated Jan 6, 2016

Text-message Reminders to Increase Rates of Postpartum Diabetes Screening in Women With Gestational Diabetes

An interventional study of Text-message reminder in Diabetes, Gestational, sponsored by University of South Florida. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-06.

Sponsored by University of South Florida · Not applicable, Interventional, and Screening

Why this study was terminated
Resources allocated elsewhere.
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

Eligible participants will be recruited after delivery while on the postpartum ward. Recruitment will be conducted by the PI or a member of the study team. After informed consent is obtained, the patients will be randomized into one of two study groups: the intervention group or the control group. 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. Women in the control group will only receive the test text-message reminder. The PI or member of the study team obtaining the informed consent will verify the participant has received the text-message prior to completing enrollment. A computer-generated randomization list will be generated according to intervention vs. control group. Simple randomization will be used for the purposes of this study. 316 participants will be recruited based on the sample size calculations already performed. One group of 316 randomized opaque envelopes will be prepared. These sealed envelopes will be stored in a secured designated area at Tampa General Hospital. Once a patient has agreed to participate and is consented an envelope will be selected from the next sequentially numbered envelope and the number on the envelope will be recorded on their study sheet. Enrollment will continue until 316 participants have been recruited.

02

Conditions studied

  • Diabetes, Gestational

Keywords

  • Gestational Diabetes
  • Postpartum screening
  • Text-messages
  • 75-g oral glucose tolerance test
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.

This study's enrollment of 57 is below the median of 110 across 549 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Women that were ever diagnosed with diabetes outside of pregnancy.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Intervention Group

    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

  • No intervention
    Control group

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

Interventions

  • BehavioralText-message reminder
06

What researchers measure

Primary outcomes

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

    Time frame: Within six months of their delivery date

Secondary outcomes

  1. Percentage of patients that receive any type of postpartum diabetes screening

    This can include any of the multiple forms of diabetes screening tests including: 75-g oral glucose tolerance test, Hemoglobin A1c, fasting plasma glucose test or others.

    Time frame: Within six months of their delivery date

07

Study locations

1 site
  • Tampa General Hospital
    Tampa, Florida 33606, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02013557
Lead sponsor
University of South Florida
Responsible party
Sponsor
First posted
Dec 17, 2013
Start date
Jan 2014
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Jan 6, 2016

Study contacts

Judette Louis, MD
principal investigator · University of South Florida Department of Obstetrics and Gynecology
Angela Gonzalez, MD
study chair · University of South Florida Department of Obstetrics and Gynecology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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