Clinical Trial: Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy

Brief Summary: Maternal diabetes in pregnancy can negatively impact fetal well-being and contribute to adverse pregnancy outcomes. Much of the morbidity associated with diabetes in pregnancy can be minimized with tight glucose control. A number of studies in non-pregnant populations have highlighted the feasibility, acceptability and efficacy of text messaging interventions for improving diabetic compliance and control. This study will investigate whether a text messaging intervention is feasible and effective in an urban, diabetic, obstetric clinic and whether this intervention can improve compliance with diabetes care, glucose control and pregnancy outcomes. The study will also assess satisfaction with the intervention itself.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome:

  • Patient Satisfaction [ Time Frame: date of enrollment up to 12 weeks post partum ]
    Patient satisfaction with the texting intervention as measured by a post-study survey
  • Compliance with Obstetric and Diabetes Care [ Time Frame: OB screening visit through 12 weeks postpartum ]
    Proportion of prenatal visits attended, proportion of assigned blood glucose logs sent to clinic for review, proportion of assigned blood glucose values checked, compliance with attendance at postpartum visit.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy measures [ Time Frame: Diabetes diagnosis through 12 weeks postpartum ]
    Measuring the proportion of blood glucose values within the target range each week; mean fasting and postprandial blood glucose values measured weekly; change in hemoglobin A1C (for pregestational diabetics) from initiation of care to the third trimester
  • Healthcare Utilization Measures [ Time Frame: Screening OB visit through 12 weeks postpartum ]
    Measuring the number of visits to the perinatal evaluation center related to diabetes care and the total number of antepartum hospitalizations.
  • Maternal Outcomes [ Time Frame: Delivery date through 12 weeks postpartum ]
    Measuring the mode of delivery (spontaneous vaginal, operative vaginal, cesarean section), complications of delivery (shoulder dystocia, postpartum hemorrhage, third and fourth degree lacerations), and length of hospital stay.
  • Neonatal Outcomes [ Time Frame: Neonate delivery through 12 weeks postpartum ]
    Measuring fetal demise; neonatal death; birthweight; large for gestational age; small for gestational age; APGAR scores; umbilical cord blood gas; NICU admission; respiratory distress; hypoglycemia; hyperbilirubinemia; length of hospital stay


Original Secondary Outcome: Same as current

Information By: University of Pennsylvania

Dates:
Date Received: October 24, 2013
Date Started: January 2013
Date Completion:
Last Updated: February 19, 2015
Last Verified: February 2015