PregnancyNCT02444325
Diabetes Group Prenatal Care
A study testing Group prenatal care in people with Pregnancy and Gestational Diabetes, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes, Type 2 Diabetes
- What is being tested?
- Group prenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 27 Sep 2017
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Denver Health
Denver, Colorado, 80204
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
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.
Read the 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.
- Conditions
- Pregnancy, Gestational Diabetes, Type 2 Diabetes
- Being tested
- Group prenatal care
- Keywords
- group prenatal care, CenteringPregnancy, diabetes
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group prenatal careBehavioural
Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
| Study group | Role | What they receive |
|---|---|---|
| Routine Prenatal Care | No intervention | 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 prenatal care | Experimental | 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. Receives: Behavioral: Group prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 37-39 weeks gestation
Secondary outcomes (7)
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
Measured: baseline and 4-12 weeks postpartum
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
Measured: 37-39 weeks
Birthweight
Determine the effect of group prenatal care on birthweight
Measured: delivery admission
Gestational age at delivery
Determine the effect of group prenatal care on preterm delivery
Measured: delivery admission
Mean 3rd trimester fasting blood glucose
Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose
Measured: baseline through delivery
Breastfeeding
Determine the effect of group prenatal care on initiating breastfeeding
Measured: 4-12 weeks postpartum
Contraception
Determine the effect of group prenatal care on initiating contraception
Measured: 4-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completion6 Jul 2017
- Study completion27 Sep 2017
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 Washington University School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health Medical Center
- Responsible party
- Sponsor
- Investigators
- Methodius G Tuuli, MD, MPH, Study director, Assistant Professor, Washington University in St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444325
- Sponsor's protocol ID
- 201503174
- Status last verified
- Jan 2018
- First submitted
- 27 Apr 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02444325
- Acronym / sponsor ID
- 201503174
- Conditions
- Pregnancy, Gestational Diabetes, Type 2 Diabetes
- Keywords
- group prenatal care, CenteringPregnancy, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Denver Health Medical Center
- Study start
- May 2015
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 14 May 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Prenatal Care | No intervention | –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 prenatal care | Experimental | Behavioral: Group prenatal careGroup 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 prenatal careWomen will receive their prenatal care in a group rather than in the 1:1 traditional manner. | Behavioural | Group prenatal care |
Primary outcome
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
Time frame: 37-39 weeks gestation
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.
7 secondary outcomes
effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale
Time frame: baseline and 4-12 weeks postpartum
effect of group prenatal care on perceived social support as assessed by the Social Support Scale
Time frame: 37-39 weeks
Birthweight
Time frame: delivery admission
Gestational age at delivery
Time frame: delivery admission
Mean 3rd trimester fasting blood glucose
Time frame: baseline through delivery
Breastfeeding
Time frame: 4-12 weeks postpartum
Contraception
Time frame: 4-12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
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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.
Methodius G Tuuli, MD, MPH study director
Assistant Professor, Washington University in St. Louis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group prenatal care in people with Pregnancy and Gestational Diabetes, run by Washington University School of Medicine at 2 sites 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure (time frame: 37-39 weeks gestation). 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 5 Jan 2018.