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NCT Number: NCT01973374

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.

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Key information

Conditions

Diabetes in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Texting Interventions Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Message Intervention

Behavioral

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: Sugar Text

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2013
Registry last updated
Feb 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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