Clinical trial NCT02444325: Diabetes Group Prenatal Care
Official title: Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Gestational Diabetes
Type 2 Diabetes
Keywords: group prenatal care
CenteringPregnancy
diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Denver Health Medical Center
First posted: 2015-05-14
Enrollment: 84
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 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.

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

Primary outcomes:
measure: effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
timeFrame: 37-39 weeks gestation
Secondary outcomes:
measure: effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale
timeFrame: baseline and 4-12 weeks postpartum
measure: effect of group prenatal care on perceived social support as assessed by the Social Support Scale
timeFrame: 37-39 weeks
measure: Birthweight
timeFrame: delivery admission
measure: Gestational age at delivery
timeFrame: delivery admission
measure: Mean 3rd trimester fasting blood glucose
timeFrame: baseline through delivery
measure: Breastfeeding
timeFrame: 4-12 weeks postpartum
measure: Contraception
timeFrame: 4-12 weeks postpartum
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
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: Methodius G Tuuli, MD, MPH
role: STUDY_DIRECTOR
References: