Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03025984 |
| Other study ID # |
22596 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
November 2023 |
| Source |
St. Louis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Diabetes is a common complication of pregnancy that increases risks for both the mother and
baby. Poorly controlled diabetes has been associated with very large babies, congenital heart
defects, stillbirth, birth trauma, and maternal infections among other complications.
Patients with diabetes in pregnancy require more frequent prenatal visits and fetal
evaluation, and must shoulder the burden of mastering management of a complicated care
regimen. With the ever-expanding world of technology, more healthcare practices are using
cell phones, texting, and social media to interact with patients. Use of this technology has
been successful in management of chronic diseases and as reminder systems. The investigators
propose a randomized clinical trial to investigate patient adherence to recommended care
regimen after intervention of a text message reminder and education system.
Description:
As a part of routine care, pregnant women without known diabetes undergo screening and
testing for gestational diabetes either with a two-hour glucose tolerance testing or a
one-hour glucose challenge test followed by a three-hour glucose tolerance test in the event
of failure of the one-hour test.
Women who have been given the diagnosis of gestational diabetes mellitus (GDM) by failing
this diabetes testing and who meet the inclusion and exclusion criteria shall be approached
and offered enrollment in the study. Women with known type 2 diabetes mellitus (T2DM)
(pre-gestational diabetes) and women diagnosed elsewhere with GDM who meet the inclusion and
exclusion criteria will be offered enrollment when they establish prenatal care. Patients who
consent to participate in the study shall be randomized to either the intervention or the
contact control group. For randomization purposes, an equal number of notecards will be made
for the two groups. These will all be placed in sealed envelopes and shuffled. At the time of
patient inclusion, an envelope will be selected by the consenting practitioner. If a patient
declines receiving text messages but consents to have her medical record reviewed for
adherence to her diabetes care regimen and glycemic control, she will be enrolled in the
standard of care control group. A baseline hemoglobin A1c (HbA1c) is obtained.
Patients in all groups shall receive initial diabetes education and started on an
individualized diabetic diet regimen. Patients with GDM who develop a requirement for either
oral medication or insulin will remain in the same group to which they were initially
randomized. An HbA1c level is obtained every one to three months during pregnancy as well as
near the time of delivery.
Patients in the intervention group will receive reminders based on their individual disease
treatment. A text message shall be sent one day (12 to 36 hours) before appointments to
remind about the appointment and with instructions to bring glucose and food records to the
appointment. If medication changes are made at the appointment, the patient will receive a
text message reminder the day after her appointment to reinforce the regimen. Postpartum
patients who had GDM will receive a text message reminder to complete their glucose tolerance
test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10
weeks postpartum if the testing is not completed. Women with T2DM will be reminded to bring
glucose and food records to their postpartum visits. Participants will be contacted through
Google Voice which is a Google system requiring a secure login and password.
Patients in the contact control group will be enrolled in the text4baby program with
assistance from a healthcare provider. As the study will conclude upon the patient's
postpartum visit, she will be offered the option of discontinuing messages, which otherwise
would continue through the infant's first year of life.
Hospitalizations Patient hospitalization for diabetic control shall be recorded for data
collection. Patients in the intervention group will not be contacted during their
hospitalization. If medicine adjustments are made during their hospitalization, a reminder
text message with the new regimen shall be sent the day after discharge. Contact will then
resume by the above stated schedule. If a patient is hospitalized temporarily for a reason
other than diabetes, contact will resume upon discharge. If the patient is hospitalized for
the remainder of the pregnancy, the patient will be removed from the study. Triage visits
will not be followed.
Delivery Delivery details will be abstracted from patient charts and shall include
gestational age at delivery, fetal weight, vaginal versus cesarean delivery, incidence of
shoulder dystocia, APGAR scores, and umbilical cord blood gases. The newborn chart shall be
reviewed for the number of days spent in the neonatal intensive care unit, incidence of
hypoglycemia and whether IV dextrose was required, and need for ventilator support or
surfactant administration.
Maternal Complications Incidence of postpartum wound infections or dehiscence shall be
collected.
Postpartum The postpartum glucose tolerance tests of women who had GDM will be reviewed to
determine her glucose tolerance status.
Questionnaires/Surveys The participating patients will be asked to complete a survey upon
entry into the study to identify barriers to their healthcare and their baseline knowledge of
diabetes. A survey at the completion of their study (the postpartum visit or later) will be
requested to evaluate patient perspectives on the study, their pregnancy and any perceived
benefit from participation. The postpartum survey will be either completed at a postpartum
visit, mailed to subjects, completed on line or subjects will be contacted by phone to
complete the survey. If subjects do not return for a postpartum visit or do not complete the
survey at that visit, three attempts will be made to contact subject for completion of the
departure survey.
For participants who did not sign a version of the consent form that allowed for completion
of the departure survey over the phone or online:
If their participation is ongoing, they will be approached at one of their visits and asked
to review and sign an updated version of the consent form.
For subjects who have completed the pregnancy portion of their participation in the study but
who did not complete a departure survey:
Subjects will be contacted over the phone to obtain permission to allow completion of this
survey over the phone, by mail or online. A phone script will be used to contact patients. If
subjects cannot be reached by phone, a letter will be sent to their home address. A maximum
of three phone attempts will be made to contact subject.
