PregnancyNCT03080337
Group vs. Traditional Diabetes Prenatal Care
A study testing Group Care in people with Pregnancy and Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- What is being tested?
- Group Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2017to 22 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinically confirmed viable pregnancy at the time of enrollment.
- Able to provide consent for participation.
- Diabetes diagnosed prior to 12 weeks gestation.
- Initiation of care by 20 weeks gestation.
- Age 18 years or older.
Who cannot join
- Not planning to deliver at UnityPoint Health- Meriter Hospital.
Trial locations and contacts
1 site in 1 country.
United States1 site
UnityPoint Health- Meriter Hospital
Madison, Wisconsin, 53715
About this study
Official title: Group Prenatal Care Compared to Traditional Prenatal Care for Women With Pre-gestational Diabetes: A Randomized Clinical Trial.
This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.
- Being tested
- Group Care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CareOther
Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Care | No intervention | If the participant is randomized to the individual prenatal care model, she will continue to receive individualized care in the prenatal clinic. This includes being seen by both a MFM specialist and possibly an endocrinologist at each prenatal visit. During the prenatal visit, the individual caregivers are responsible for discussing educational topics that they feel are relevant to the patient. Patients are seen every two weeks for Traditional Care. |
| Group Care | Experimental | If the participant is randomized into the group prenatal care model she will be placed in a group of approximately 6-10 women of approximately the same gestational age. These women will then have sessions scheduled at the same intervals they would have had their traditional prenatal visits, every two weeks until 36 weeks and then weekly until delivery, 12 sessions in total. Each session will last between 90-120 minutes. In the group prenatal care model, the entire visit time will be face to face with a provider and the group. Billing will be done through the standard reimbursement system since the program will follow the schedule of prenatal visits recommended by the American Congress of Obstetricians and Gynecologist. Receives: Other: Group Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with glucose testing over time
Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Secondary outcomes (12)
Maternal Weight Gain (kilograms)
Compare maternal weight gain of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Length of stay for delivery (days)
Compare maternal hospital length of stay for delivery of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Presence of infection (Y/N)
Compare presence of infection in participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)
Compare type of delivery in participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Blood Pressure (mm Hg)
Compare blood pressures in participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Neonatal Birth Weight (grams)
Compare neonatal birth weight of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Neonatal Length of stay (days)
Compare neonatal length of stay of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Neonatal APGAR Score (0-10)
Compare neonatal APGAR score of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Gestational Age at Delivery (weeks)
Compare gestational age at delivery of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey)
Compare pregnancy and diabetes related knowledge of participants in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Patient and care giver satisfaction (survey)
Compare satisfaction of participants and their respective providers in the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Cost-effectiveness (dollars per hour)
Compare cost-effectiveness of the group care model to the control group: a traditional, individual care model.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start17 Mar 2017
- Primary completion22 Feb 2018
- Study completion22 Feb 2018
Why it stopped: This study is being closed prematurely due to resource availability and agreement constraints with the collaborating research site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Akron Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Kara Hoppe, DO, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080337
- Sponsor's protocol ID
- 2016-015
- Other IDs
- A532860, SMPH/OBSTET & GYNECOL/OBSTET
- Status last verified
- Dec 2019
- First submitted
- 27 Feb 2017
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in a REDCap database with University Hospitals, Cleveland.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Prenatal Care Compared to Traditional Prenatal Care for Women With Pre-gestational Diabetes: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03080337
- Acronym / sponsor ID
- 2016-015
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study is being closed prematurely due to resource availability and agreement constraints with the collaborating research site.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Akron Children's Hospital
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 22 Feb 2018 (actual)
- Study completion
- 22 Feb 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Care | No intervention | –If the participant is randomized to the individual prenatal care model, she will continue to receive individualized care in the prenatal clinic. This includes being seen by both a MFM specialist and possibly an endocrinologist at each prenatal visit. During the prenatal visit, the individual caregivers are responsible for discussing educational topics that they feel are relevant to the patient. Patients are seen every two weeks for Traditional Care. |
| Group Care | Experimental | Other: Group CareIf the participant is randomized into the group prenatal care model she will be placed in a group of approximately 6-10 women of approximately the same gestational age. These women will then have sessions scheduled at the same intervals they would have had their traditional prenatal visits, every two weeks until 36 weeks and then weekly until delivery, 12 sessions in total. Each session will last between 90-120 minutes. In the group prenatal care model, the entire visit time will be face to face with a provider and the group. Billing will be done through the standard reimbursement system since the program will follow the schedule of prenatal visits recommended by the American Congress of Obstetricians and Gynecologist. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinically confirmed viable pregnancy at the time of enrollment.
- Able to provide consent for participation.
- Diabetes diagnosed prior to 12 weeks gestation.
- Initiation of care by 20 weeks gestation.
- Age 18 years or older.
Key exclusion criteria (1 listed)
- Not planning to deliver at UnityPoint Health- Meriter Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CareParticipation in 12 group sessions with 6-10 women who are also pregnant and have diabetes. | Other | Group Care |
Primary outcome
Compliance with glucose testing over time
Time frame: 2 years
Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model.
12 secondary outcomes
Maternal Weight Gain (kilograms)
Time frame: 2 years
Length of stay for delivery (days)
Time frame: 2 years
Presence of infection (Y/N)
Time frame: 2 years
Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)
Time frame: 2 years
Blood Pressure (mm Hg)
Time frame: 2 years
Neonatal Birth Weight (grams)
Time frame: 2 years
Neonatal Length of stay (days)
Time frame: 2 years
Neonatal APGAR Score (0-10)
Time frame: 2 years
Gestational Age at Delivery (weeks)
Time frame: 2 years
Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey)
Time frame: 2 years
Patient and care giver satisfaction (survey)
Time frame: 2 years
Cost-effectiveness (dollars per hour)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: This study is being closed prematurely due to resource availability and agreement constraints with the collaborating research site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be shared in a REDCap database with University Hospitals, Cleveland.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Hoppe, DO principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Care in people with Pregnancy and Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study is being closed prematurely due to resource availability and agreement constraints with the collaborating research site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with glucose testing over time (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.