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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celeste Durnwald, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01973374
First received: October 24, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Diabetes in Pregnancy
Gestational Diabetes
Texting Interventions
Behavioral: Text Message Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 30
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women aged 18-50 years
  • Planned delivery at Hospital of the University of Pennsylvania

Exclusion Criteria:

  • Gestational age greater than 34 weeks at initial visit in the Penn Perinatal Diabetes Program
  • Women who are unable to read English as all text messages will be in English
  • Women who do not have a cellular phone capable of receiving text messages as this is the study intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973374

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: Celeste Durnwald, Assistant Professor, Maternal Fetal Medicine, Department of Obstetrics and Gynecology Director, Penn Perinatal Diabetes Program Director, High Risk Clinic at the Helen O. Dickens Center for Women's Health, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01973374     History of Changes
Other Study ID Numbers: 817181
Study First Received: October 24, 2013
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Pregnancy in Diabetics
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on November 27, 2014