Back to resultsDiabetes Group Prenatal Care
Primary Purpose
Pregnancy, Gestational Diabetes, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group prenatal care
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring group prenatal care, CenteringPregnancy, diabetes
Eligibility Criteria
Inclusion Criteria:
- English (WUMC) or Spanish speaking (DH)
- Type 2 White's Class B diabetes OR gestational diabetes diagnosed by 2-step method < 32 weeks
- Ability to attend group prenatal visit at specified days and times
- Willingness to be randomized
- Randomization at 22 weeks 0 days-32 weeks 0 days
- Ability to give informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Denver Health
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine Prenatal Care
Group prenatal care
Arm 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. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.
Group visits will be held every 2 weeks in a continuous cycle through a four 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 4-12 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 2 CenteringPregnancy trained providers at each site and an obstetric provider. Women may be instructed to have additional visits in the traditional clinic at the discretion of the obstetric provider.
Outcomes
Primary Outcome Measures
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
Determine the effect of group prenatal care on maternal diabetes self-care activities as measured by the Diabetes Self-care Activities Measure and confirmed by percentage of recommended blood glucose values completed on logs since initial study visit.
Secondary Outcome Measures
effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale
Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale
effect of group prenatal care on perceived social support as assessed by the Social Support Scale
Determine the effect of group prenatal care on perceived social support through the Social Support Scale
Birthweight
Determine the effect of group prenatal care on birthweight
Gestational age at delivery
Determine the effect of group prenatal care on preterm delivery
Mean 3rd trimester fasting blood glucose
Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose
Breastfeeding
Determine the effect of group prenatal care on initiating breastfeeding
Contraception
Determine the effect of group prenatal care on initiating contraception
Full Information
NCT ID
NCT02444325
First Posted
April 27, 2015
Last Updated
January 3, 2018
Sponsor
Washington University School of Medicine
Collaborators
Denver Health Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02444325
Brief Title
Diabetes Group Prenatal Care
Official Title
Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Denver Health Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators primary objective is to conduct a pilot randomized trial to determine the effect of group prenatal care on self-care activities in women with diabetes.
Detailed Description
Long term, the investigators aim 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 pilot randomized trial to determine the effect of group prenatal care on self-care activities, which have been associated with improved glycemic control, in women with diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Gestational Diabetes, Type 2 Diabetes
Keywords
group prenatal care, CenteringPregnancy, diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Prenatal Care
Arm Type
No Intervention
Arm 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. Each subject's medical chart will be reviewed for demographics, antenatal management, maternal and neonatal outcomes.
Arm Title
Group prenatal care
Arm Type
Experimental
Arm Description
Group visits will be held every 2 weeks in a continuous cycle through a four 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 4-12 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 2 CenteringPregnancy trained providers at each site 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(s)
Group prenatal care
Intervention Description
Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
Primary Outcome Measure Information:
Title
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
Description
Determine the effect of group prenatal care on maternal diabetes self-care activities as measured by the Diabetes Self-care Activities Measure and confirmed by percentage of recommended blood glucose values completed on logs since initial study visit.
Time Frame
37-39 weeks gestation
Secondary Outcome Measure Information:
Title
effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale
Description
Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale
Time Frame
baseline and 4-12 weeks postpartum
Title
effect of group prenatal care on perceived social support as assessed by the Social Support Scale
Description
Determine the effect of group prenatal care on perceived social support through the Social Support Scale
Time Frame
37-39 weeks
Title
Birthweight
Description
Determine the effect of group prenatal care on birthweight
Time Frame
delivery admission
Title
Gestational age at delivery
Description
Determine the effect of group prenatal care on preterm delivery
Time Frame
delivery admission
Title
Mean 3rd trimester fasting blood glucose
Description
Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose
Time Frame
baseline through delivery
Title
Breastfeeding
Description
Determine the effect of group prenatal care on initiating breastfeeding
Time Frame
4-12 weeks postpartum
Title
Contraception
Description
Determine the effect of group prenatal care on initiating contraception
Time Frame
4-12 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English (WUMC) or Spanish speaking (DH)
Type 2 White's Class B diabetes OR gestational diabetes diagnosed by 2-step method < 32 weeks
Ability to attend group prenatal visit at specified days and times
Willingness to be randomized
Randomization at 22 weeks 0 days-32 weeks 0 days
Ability to give informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Methodius G Tuuli, MD, MPH
Organizational Affiliation
Assistant Professor, Washington University in St. Louis
Official's Role
Study Director
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Diabetes Group Prenatal Care
We'll reach out to this number within 24 hrs