Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy
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.
Diabetes in Pregnancy
Behavioral: Text Message Intervention
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy|
- Patient Satisfaction [ Time Frame: date of enrollment up to 12 weeks post partum ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
- Efficacy measures [ Time Frame: Diabetes diagnosis through 12 weeks postpartum ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|No Intervention: Routine Care|
Experimental: Text Message Intervention
The text message intervention group receives usual prenatal and diabetic care in addition to two text messages per week throughout the pregnancy and a reminder text message prior to the postpartum visit. The text message intervention group also fills out a survey about the intervention after delivery.
|Behavioral: Text Message Intervention|
|Contact: Celeste P Durnwald, MDfirstname.lastname@example.org|
|Contact: Hayley S Quant, MD||215-662-6647||Hayley.Quant@uphs.upenn.edu|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Hayley S Quant, MD 215-662-6647 Hayley.Quant@uphs.upenn.edu|
|Contact: Brittany A Araujo, BS 215-615-6047 email@example.com|
|Principal Investigator: Celeste P Durnwald, MD|