<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03301792</url>
  </required_header>
  <id_info>
    <org_study_id>201707118; 201906068 (1001)</org_study_id>
    <nct_id>NCT03301792</nct_id>
  </id_info>
  <brief_title>Group Versus Traditional Prenatal Care for Diabetes</brief_title>
  <official_title>Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators primary objective is to conduct a randomized trial to determine the effect&#xD;
      of diabetes group prenatal care on glycemic control and postpartum weight retention in women&#xD;
      with type 2 diabetes and gestational diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long term, the investigator aims to test the central hypothesis that group prenatal care,&#xD;
      compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum&#xD;
      weight retention in women with type 2 and gestational diabetes. The objective of this&#xD;
      proposal is to conduct a randomized trial in two phases to determine the effect of Diabetes&#xD;
      Group Care (GC) on glycemic control in pregnant women with T2DM and GDM (Antepartum Phase)&#xD;
      and the impact on postpartum weight retention (Postpartum Phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Diabetes Group Care on maternal glycemic control</measure>
    <time_frame>Initial study visit (22-34 weeks) through one year postpartum</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of Diabetes Group Care on postpartum weight retention</measure>
    <time_frame>Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completion of self-care activities</measure>
    <time_frame>37-39 weeks gestation</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Diabetes Group Care on number of blood glucose values</measure>
    <time_frame>Initial study visit (22-34 weeks) through 39 weeks gestation</time_frame>
    <description>Determine the effect of Diabetes Group care by measuring the percentage of recommended blood glucose values entered on logs since initial study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Antepartum Compliance</measure>
    <time_frame>Initial study visit (22-34weeks) through 4-12 weeks postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal antepartum compliance by assessing the number of prenatal appointments attended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Antepartum Physical Activity/Eating Behavior</measure>
    <time_frame>Initial study visit (22-34weeks) through one year postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal antepartum physical activity/eating behavior using a physical activity/eating behavior questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Antepartum Weight Gain</measure>
    <time_frame>Initial study visit (22-34weeks) through delivery</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Intrapartum Mode of Delivery</measure>
    <time_frame>Delivery through 4-12 weeks postpartum</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Intrapartum Hypertensive Disease of Pregnancy</measure>
    <time_frame>Delivery through 4-12 weeks postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal intrapartum hypertensive disorders of pregnancy by assessing whether they develop gestational hypertension, preeclampsia, or eclampsia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Postpartum Readmission</measure>
    <time_frame>4-12 weeks postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal postpartum readmission by assessing number of maternal hospital readmissions within 6 weeks postpartum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Postpartum Visit Attendance</measure>
    <time_frame>4-12 weeks postpartum</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Postpartum Glucose Testing</measure>
    <time_frame>4-12 weeks postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal postpartum glucose testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Postpartum Breastfeeding</measure>
    <time_frame>4-12 weeks postpartum, six months postpartum, one year postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal Postpartum Contraception</measure>
    <time_frame>4-12 weeks postpartum, six months postpartum, one year postpartum</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Birthweight</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal birth weight in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Gestational Age</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal gestational age at delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal APGAR Scores</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal APGAR score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Adiposity and body composition</measure>
    <time_frame>delivery admission through one year postpartum</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal body measurements-Weight</measure>
    <time_frame>delivery through one year postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal weight in grams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal body measurements-Length</measure>
    <time_frame>delivery through one year postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal length in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal body measurements-Head Circumference</measure>
    <time_frame>delivery through one year postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal NICU Admission</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal NICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Hypoglycemia</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Outcomes</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal hematocrit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Jaundice</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal jaundice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Stillbirth Rates</measure>
    <time_frame>delivery admission</time_frame>
    <description>Determine the effect of Diabetes Group Care on neonatal stillbirth rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Stress</measure>
    <time_frame>Initial study visit (22-34weeks) through one year postpartum</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Stress</measure>
    <time_frame>Initial study visit (22-34weeks) and six months postpartum</time_frame>
    <description>Determine the effect of Diabetes Group Care on psychosocial stress by comparing life events checklist at study entry visit and six months postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Distress</measure>
    <time_frame>Initial study visit (22-34 weeks) through 4-12 weeks postpartum</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Anxiety</measure>
    <time_frame>Initial study visit (22-34weeks) through one year postpartum</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Depression</measure>
    <time_frame>Initial study visit (22-34weeks) through 1 year postpartum</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial Stress and Depression</measure>
    <time_frame>Delivery through postpartum</time_frame>
    <description>Determine the effects of Diabetes Group Care on stress and depression by measuring alcohol or drug use in first year postpartum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">117</enrollment>
  <condition>Pregnancy</condition>
  <condition>Gestational Diabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Routine Prenatal Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group prenatal care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group prenatal care</intervention_name>
    <description>Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.</description>
    <arm_group_label>Group prenatal care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. English speaking&#xD;
&#xD;
          2. Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely&#xD;
             pre-existing Type 2 diabetes with one of the following during pregnancy and &lt;/= 34&#xD;
             weeks:&#xD;
&#xD;
               1. 1 hour glucose challenge test &gt;/= 185mg/dL OR&#xD;
&#xD;
               2. A1c &gt;/= 6.5% OR&#xD;
&#xD;
               3. Fasting plasma glucose &gt; 126mg/dL (2)&#xD;
&#xD;
          3. Ability to attend group prenatal visit at specified days and times&#xD;
&#xD;
          4. Willingness to be randomized at 22 weeks 0 days-34 weeks 0 days OR initial visit&#xD;
             between 24 weeks 0 days-34 weeks 0 days&#xD;
&#xD;
          5. Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior participation in diabetes group care&#xD;
&#xD;
          2. Type 1 Diabetes&#xD;
&#xD;
          3. Multiple gestation&#xD;
&#xD;
          4. Major fetal anomaly&#xD;
&#xD;
          5. Serious medical co-morbidity necessitating more care than can be safely provided in&#xD;
             group setting, as deemed by medical provider.&#xD;
&#xD;
          6. Serious psychiatric illness including schizophrenia necessitating more care than can&#xD;
             safely be provided in group setting, as deemed by medical provider.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebony B. Carter, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor, Washington University in St. Louis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Group prenatal care</keyword>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03301792
org study id: 201707118; 201906068 (1001)
nct id: NCT03301792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effect of Diabetes Group Care on maternal glycemic control
time frame: Initial study visit (22-34 weeks) through one year postpartum
description: 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
measure: 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
description: 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.
measure: Completion of self-care activities
time frame: 37-39 weeks gestation
description: 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)
measure: Effect of Diabetes Group Care on number of blood glucose values
time frame: Initial study visit (22-34 weeks) through 39 weeks gestation
description: Determine the effect of Diabetes Group care by measuring the percentage of recommended blood glucose values entered on logs since initial study visit
measure: Maternal Antepartum Compliance
time frame: Initial study visit (22-34weeks) through 4-12 weeks postpartum
description: Determine the effect of Diabetes Group Care on maternal antepartum compliance by assessing the number of prenatal appointments attended
measure: Maternal Antepartum Physical Activity/Eating Behavior
time frame: Initial study visit (22-34weeks) through one year postpartum
description: Determine the effect of Diabetes Group Care on maternal antepartum physical activity/eating behavior using a physical activity/eating behavior questionnaire
measure: Maternal Antepartum Weight Gain
time frame: Initial study visit (22-34weeks) through delivery
description: Determine the effect of Diabetes Group Care on maternal antepartum weight gain in pounds
measure: Maternal Intrapartum Mode of Delivery
time frame: Delivery through 4-12 weeks postpartum
description: 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.
measure: Maternal Intrapartum Hypertensive Disease of Pregnancy
time frame: Delivery through 4-12 weeks postpartum
description: Determine the effect of Diabetes Group Care on maternal intrapartum hypertensive disorders of pregnancy by assessing whether they develop gestational hypertension, preeclampsia, or eclampsia.
measure: Maternal Postpartum Readmission
time frame: 4-12 weeks postpartum
description: Determine the effect of Diabetes Group Care on maternal postpartum readmission by assessing number of maternal hospital readmissions within 6 weeks postpartum.
measure: Maternal Postpartum Visit Attendance
time frame: 4-12 weeks postpartum
description: 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.
measure: Maternal Postpartum Glucose Testing
time frame: 4-12 weeks postpartum
description: Determine the effect of Diabetes Group Care on maternal postpartum glucose testing
measure: Maternal Postpartum Breastfeeding
time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum
description: Determine the effect of Diabetes Group Care on maternal postpartum breastfeeding using a breastfeeding scale questionnaire
measure: Maternal Postpartum Contraception
time frame: 4-12 weeks postpartum, six months postpartum, one year postpartum
description: 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.
measure: Neonatal Birthweight
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal birth weight in grams
measure: Neonatal Gestational Age
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal gestational age at delivery
measure: Neonatal APGAR Scores
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal APGAR score
measure: Neonatal Adiposity and body composition
time frame: delivery admission through one year postpartum
description: 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.
measure: Neonatal body measurements-Weight
time frame: delivery through one year postpartum
description: Determine the effect of Diabetes Group Care on neonatal weight in grams
measure: Neonatal body measurements-Length
time frame: delivery through one year postpartum
description: Determine the effect of Diabetes Group Care on neonatal length in centimeters
measure: Neonatal body measurements-Head Circumference
time frame: delivery through one year postpartum
description: Determine the effect of Diabetes Group Care on neonatal head circumference in centimeters
measure: Neonatal NICU Admission
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal NICU admission
measure: Neonatal Hypoglycemia
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal hypoglycemia
measure: Neonatal Outcomes
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal hematocrit
measure: Neonatal Jaundice
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal jaundice
measure: Neonatal Stillbirth Rates
time frame: delivery admission
description: Determine the effect of Diabetes Group Care on neonatal stillbirth rates
measure: Psychosocial Stress
time frame: Initial study visit (22-34weeks) through one year postpartum
description: 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.
measure: Psychosocial Stress
time frame: Initial study visit (22-34weeks) and six months postpartum
description: Determine the effect of Diabetes Group Care on psychosocial stress by comparing life events checklist at study entry visit and six months postpartum
measure: Psychosocial Distress
time frame: Initial study visit (22-34 weeks) through 4-12 weeks postpartum
description: 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
measure: Psychosocial Anxiety
time frame: Initial study visit (22-34weeks) through one year postpartum
description: 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.
measure: Psychosocial Depression
time frame: Initial study visit (22-34weeks) through 1 year postpartum
description: 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
measure: Psychosocial Stress and Depression
time frame: Delivery through postpartum
description: Determine the effects of Diabetes Group Care on stress and depression by measuring alcohol or drug use in first year postpartum
arm group label: Routine Prenatal Care
arm group type: No Intervention
description: 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.
arm group label: Group prenatal care
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Group prenatal care
description: Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
arm group label: Group prenatal care
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ebony B. Carter, MD, MPH
role: Principal Investigator
affiliation: Assistant Professor, Washington University in St. Louis
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus