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Group Versus Traditional Prenatal Care for Diabetes

This study is currently recruiting participants.
Verified October 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03301792
First Posted: October 4, 2017
Last Update Posted: October 4, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control in women with type 2 diabetes and gestational diabetes.

Condition Intervention
Pregnancy Gestational Diabetes Type 2 Diabetes Behavioral: Group prenatal care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Effect of Diabetes Group Care on maternal glycemic control [ Time Frame: Initial study visit (22-34 weeks) through delivery ]
    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.


Secondary Outcome Measures:
  • 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)

  • 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

  • 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

  • Maternal Antepartum Physical Activity/Eating Behavior [ Time Frame: Initial study visit (22-34weeks) through 4-12 weeks postpartum ]
    Determine the effect of Diabetes Group Care on maternal antepartum physical activity/eating behavior using a physical activity/eating behavior questionnaire

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • Maternal Postpartum Glucose Testing [ Time Frame: 4-12 weeks postpartum ]
    Determine the effect of Diabetes Group Care on maternal postpartum glucose testing

  • Maternal Postpartum Breastfeeding [ Time Frame: 4-12 weeks postpartum ]
    Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire

  • Maternal Postpartum Contraception [ Time Frame: 4-12 weeks 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.

  • Maternal Postpartum Weight Retention [ Time Frame: 4-12 weeks postpartum ]
    Determine the effect of Diabetes Group Care on maternal postpartum weight retention in pounds

  • Neonatal Birthweight [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal birth weight in grams

  • Neonatal Gestational Age [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal gestational age at delivery

  • Neonatal APGAR Scores [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal APGAR score

  • Neonatal Adiposity [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal adiposity and body composition system

  • Neonatal NICU Admission [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal NICU admission

  • Neonatal Hypoglycemia [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal hypoglycemia

  • Neonatal Outcomes [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal hematocrit

  • Neonatal Jaundice [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal jaundice

  • Neonatal Stillbirth Rates [ Time Frame: delivery admission ]
    Determine the effect of Diabetes Group Care on neonatal stillbirth rates

  • Psychosocial Stress [ Time Frame: Initial study visit (22-34weeks) through 4-12 weeks 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.

  • 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

  • Psychosocial Anxiety [ Time Frame: Initial study visit (22-34weeks) through 4-12 weeks 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.

  • Psychosocial Depression [ Time Frame: Initial study visit (22-34weeks) through 4-12 weeks 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.


Estimated Enrollment: 106
Actual Study Start Date: September 14, 2017
Estimated Study Completion Date: September 10, 2020
Estimated Primary Completion Date: June 10, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Routine Prenatal Care
Subjects randomized to routine care will receive their care in the usual diabetic clinic attended by residents and faculty. They will receive consultation with the diabetes educator at diagnosis and as needed. Patients are seen every 2 weeks (or more by provider discretion) until 37 weeks and weekly until delivery. Visits are 10-15 minutes and focus on routine screening tests and review of blood sugar logs/medication titration.
Experimental: Group prenatal care
Group visits will be held every 2 weeks in a continuous cycle through a six session curriculum. Women will have weekly visits beginning at 37 weeks with traditional prenatal visits on the weeks when the group does not meet. Groups of 2-12 women will meet for two hour visits and much of that time will be spent on pregnancy, behavioral health, diabetes and nutrition education. Groups will be co-facilitated by a health educator and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider.
Behavioral: Group prenatal care
Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.

Detailed Description:
Long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes. The objective of this proposal is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control in pregnant women with type 2 diabetes and gestational diabetes.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • Type 2 diabetes OR gestational diabetes diagnosed by 2-step method < 34 weeks
  • 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:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03301792


Contacts
Contact: Ebony B Carter, MD, MPH 314-362-8280 cartere@wudosis.wustl.edu

Locations
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ebony B Carter, MD, MPH    314-362-8280    cartere@wudosis.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Director: Methodius G Tuuli, MD, MPH Assistant Professor, Washington University in St. Louis
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03301792     History of Changes
Other Study ID Numbers: 201707118
First Submitted: September 15, 2017
First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Group prenatal care
Diabetes

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