Sugar Text: A Randomized Controlled Trial of a Text Message Intervention for Women With Diabetes in Pregnancy (Sugar Text)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01973374|
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : February 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes in Pregnancy Gestational Diabetes Texting Interventions||Behavioral: Text Message Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
|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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973374
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|