Clinical trial NCT03301792: Group Versus Traditional Prenatal Care for Diabetes
Official title: Group Versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy
Gestational Diabetes
Type 2 Diabetes
Keywords: Group prenatal care
Diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. English speaking
2. Type 2 diabetes OR gestational diabetes diagnosed by 2-step method(1) OR likely pre-existing Type 2 diabetes with one of the following during pregnancy and \</= 34 weeks:

   1. 1 hour glucose challenge test \>/= 185mg/dL OR
   2. A1c \>/= 6.5% OR
   3. Fasting plasma glucose \> 126mg/dL (2)
3. Ability to attend group prenatal visit at specified days and times
4. 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
5. Ability to give informed consent

Exclusion Criteria:

1. Prior participation in diabetes group care
2. Type 1 Diabetes
3. Multiple gestation
4. Major fetal anomaly
5. Serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider.
6. Serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.

Primary outcomes:
measure: Effect of Diabetes Group Care on maternal glycemic control
timeFrame: Initial study visit (22-34 weeks) through one year postpartum
measure: Effect of Diabetes Group Care on postpartum weight retention
timeFrame: Pre-pregnancy weight (up to 6 months prior to initial visit) through one year postpartum
Secondary outcomes:
measure: Completion of self-care activities
timeFrame: 37-39 weeks gestation
measure: Effect of Diabetes Group Care on number of blood glucose values
timeFrame: Initial study visit (22-34 weeks) through 39 weeks gestation
measure: Maternal Antepartum Compliance
timeFrame: Initial study visit (22-34weeks) through 4-12 weeks postpartum
measure: Maternal Antepartum Physical Activity/Eating Behavior
timeFrame: Initial study visit (22-34weeks) through one year postpartum
measure: Maternal Antepartum Weight Gain
timeFrame: Initial study visit (22-34weeks) through delivery
measure: Maternal Intrapartum Mode of Delivery
timeFrame: Delivery through 4-12 weeks postpartum
measure: Maternal Intrapartum Hypertensive Disease of Pregnancy
timeFrame: Delivery through 4-12 weeks postpartum
measure: Maternal Postpartum Readmission
timeFrame: 4-12 weeks postpartum
measure: Maternal Postpartum Visit Attendance
timeFrame: 4-12 weeks postpartum
measure: Maternal Postpartum Glucose Testing
timeFrame: 4-12 weeks postpartum
measure: Maternal Postpartum Breastfeeding
timeFrame: 4-12 weeks postpartum, six months postpartum, one year postpartum
measure: Maternal Postpartum Contraception
timeFrame: 4-12 weeks postpartum, six months postpartum, one year postpartum
measure: Neonatal Birthweight
timeFrame: delivery admission
measure: Neonatal Gestational Age
timeFrame: delivery admission
measure: Neonatal APGAR Scores
timeFrame: delivery admission
measure: Neonatal Adiposity and body composition
timeFrame: delivery admission through one year postpartum
measure: Neonatal body measurements-Weight
timeFrame: delivery through one year postpartum
measure: Neonatal body measurements-Length
timeFrame: delivery through one year postpartum
measure: Neonatal body measurements-Head Circumference
timeFrame: delivery through one year postpartum
measure: Neonatal NICU Admission
timeFrame: delivery admission
measure: Neonatal Hypoglycemia
timeFrame: delivery admission
measure: Neonatal Outcomes
timeFrame: delivery admission
measure: Neonatal Jaundice
timeFrame: delivery admission
measure: Neonatal Stillbirth Rates
timeFrame: delivery admission
measure: Psychosocial Stress
timeFrame: Initial study visit (22-34weeks) through one year postpartum
measure: Psychosocial Stress
timeFrame: Initial study visit (22-34weeks) and six months postpartum
measure: Psychosocial Distress
timeFrame: Initial study visit (22-34 weeks) through 4-12 weeks postpartum
measure: Psychosocial Anxiety
timeFrame: Initial study visit (22-34weeks) through one year postpartum
measure: Psychosocial Depression
timeFrame: Initial study visit (22-34weeks) through 1 year postpartum
measure: Psychosocial Stress and Depression
timeFrame: Delivery through postpartum
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Assistant Professor, Washington University in St. Louis
name: Megan Lawlor, MD
role: PRINCIPAL_INVESTIGATOR
References: