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NCT Number: NCT03301792

Group Versus Traditional Prenatal Care for Diabetes

The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Type 2 Diabetes Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis, St Louis, Missouri, United States

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About this study

Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a randomized trial in two phases to determine the effect of Diabetes Group Care (GC) on glycemic control in pregnant women with T2DM and GDM (Antepartum Phase) and the impact on postpartum weight retention (Postpartum Phase).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English speaking
  • Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and </= 34 weeks:
  • 1 hour glucose challenge test >/= 185mg/dL OR
  • A1c >/= 6.5% OR
  • Fasting plasma glucose > 126mg/dL (2)
  • Ability to attend group prenatal visit at specified days and times
  • Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit between 24 weeks 0 days-34 weeks 0 days
  • Ability to give informed consent

Exclusion criteria

  • Prior participation in diabetes group care
  • Type 1 Diabetes
  • Multiple gestation
  • Major fetal anomaly
  • Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.
  • Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.

Treatment and study plan

Group prenatal care

Behavioral

Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.

Primary outcomes

  1. Effect of Diabetes Group Care on maternal glycemic control

    Time frame: Initial study visit (22-34 weeks) through one year postpartum

    Determine the effect of Diabetes Group care on maternal glycemic control by randomizing women to Diabetes group care or traditional care and compare 1) Mean fasting blood glucose, 2) Mean 1-hour post-prandial blood glucose, and 3) Hemoglobin A1c at delivery, 4-12 weeks postpartum, six months postpartum, one year postpartum

  2. Effect of Diabetes Group Care on postpartum weight retention

    Time frame: Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum

    Determine the impact of Diabetes Group care on postpartum weight retention in pounds based on postpartum weight retention at one year. Average weight retention will be compared at 4-12 weeks, six months postpartum, and one year postpartum.

Secondary outcomes

  1. Completion of self-care activities

    Time frame: 37-39 weeks gestation

    Determine the effect of Diabetes Group care on maternal diabetes self-care activities by using the Diabetes Self-care Activities Scale (a measure of the number of days during the prior week in which the subject followed diet, exercise, blood sugar testing, and medication adherence recommendations)

  2. Effect of Diabetes Group Care on number of blood glucose values

    Time frame: Initial study visit (22-34 weeks) through 39 weeks gestation

    Determine the effect of Diabetes Group care by measuring the percentage of recommended blood glucose values entered on logs since initial study visit

  3. Maternal Antepartum Compliance

    Time frame: Initial study visit (22-34weeks) through 4-12 weeks postpartum

    Determine the effect of Diabetes Group Care on maternal antepartum compliance by assessing the number of prenatal appointments attended

  4. Maternal Antepartum Physical Activity/Eating Behavior

    Time frame: Initial study visit (22-34weeks) through one year postpartum

    Determine the effect of Diabetes Group Care on maternal antepartum physical activity/eating behavior using a physical activity/eating behavior questionnaire

  5. Maternal Antepartum Weight Gain

    Time frame: Initial study visit (22-34weeks) through delivery

    Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds

  6. Maternal Intrapartum Mode of Delivery

    Time frame: Delivery through 4-12 weeks postpartum

    Determine the effect of Diabetes Group Care on maternal intrapartum mode of delivery by assessing whether infant was delivered spontaneously, using vacuum, forceps, or cesarean.

  7. Maternal Intrapartum Hypertensive Disease of Pregnancy

    Time frame: Delivery through 4-12 weeks postpartum

    Determine the effect of Diabetes Group Care on maternal intrapartum hypertensive disorders of pregnancy by assessing whether they develop gestational hypertension, preeclampsia, or eclampsia.

  8. Maternal Postpartum Readmission

    Time frame: 4-12 weeks postpartum

    Determine the effect of Diabetes Group Care on maternal postpartum readmission by assessing number of maternal hospital readmissions within 6 weeks postpartum.

  9. Maternal Postpartum Visit Attendance

    Time frame: 4-12 weeks postpartum

    Determine the effect of Diabetes Group Care on maternal postpartum visit attendance by assessing whether she attends a postpartum visit between 4-12 weeks postpartum.

  10. Maternal Postpartum Glucose Testing

    Time frame: 4-12 weeks postpartum

    Determine the effect of Diabetes Group Care on maternal postpartum glucose testing

  11. Maternal Postpartum Breastfeeding

    Time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum

    Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire

  12. Maternal Postpartum Contraception

    Time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum

    Determine the effect of Diabetes Group Care on maternal postpartum contraception choices by assessing use of short acting reversible contraception, long acting reversible, and sterilization.

  13. Neonatal Birthweight

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal birth weight in grams

  14. Neonatal Gestational Age

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal gestational age at delivery

  15. Neonatal APGAR Scores

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal APGAR score

  16. Neonatal Adiposity and body composition

    Time frame: delivery admission through one year postpartum

    Determine the effect of Diabetes Group Care on neonatal adiposity and body composition by air displacement plethysmography within 1 week of delivery. Skin fold thickness of triceps, subscapular, ilium, and thigh at delivery, six weeks, six months, one year postpartum.

  17. Neonatal body measurements-Weight

    Time frame: delivery through one year postpartum

    Determine the effect of Diabetes Group Care on neonatal weight in grams

  18. Neonatal body measurements-Length

    Time frame: delivery through one year postpartum

    Determine the effect of Diabetes Group Care on neonatal length in centimeters

  19. Neonatal body measurements-Head Circumference

    Time frame: delivery through one year postpartum

    Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters

  20. Neonatal NICU Admission

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal NICU admission

  21. Neonatal Hypoglycemia

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal hypoglycemia

  22. Neonatal Outcomes

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal hematocrit

  23. Neonatal Jaundice

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal jaundice

  24. Neonatal Stillbirth Rates

    Time frame: delivery admission

    Determine the effect of Diabetes Group Care on neonatal stillbirth rates

  25. Psychosocial Stress

    Time frame: Initial study visit (22-34weeks) through one year postpartum

    Determine the effect of Diabetes Group Care on psychosocial stress by comparing Cohen's Perceived Stress at study entry visit, last study visit (37-39 weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum.

  26. Psychosocial Stress

    Time frame: Initial study visit (22-34weeks) and six months postpartum

    Determine the effect of Diabetes Group Care on psychosocial stress by comparing life events checklist at study entry visit and six months postpartum

  27. Psychosocial Distress

    Time frame: Initial study visit (22-34 weeks) through 4-12 weeks postpartum

    Determine the effects of Diabetes Group Care on psychosocial stress by comparing Pregnancy Distress questionnaire at study entry, last study visit (37-39 weeks), and 4-12 weeks postpartum

  28. Psychosocial Anxiety

    Time frame: Initial study visit (22-34weeks) through one year postpartum

    Determine the effects of Diabetes Group Care on psychosocial stress by comparing GAD-7 at study entry, last study visit (37-39weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum.

  29. Psychosocial Depression

    Time frame: Initial study visit (22-34weeks) through 1 year postpartum

    Determine the effects of Diabetes Group Care on depression by comparing the Edinburgh Postnatal Depression Scale at study entry, last study visit (37-39 weeks) and 4-12 weeks postpartum, six months postpartum, one year postpartum

  30. Psychosocial Stress and Depression

    Time frame: Delivery through postpartum

    Determine the effects of Diabetes Group Care on stress and depression by measuring alcohol or drug use in first year postpartum

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Oct 4, 2017
Registry last updated
Jan 23, 2026

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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