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Diabetes Group Prenatal Care

Not Applicable
Completed
Conditions
Gestational Diabetes
Pregnancy
Type 2 Diabetes
Interventions
Behavioral: Group prenatal care
Registration Number
NCT02444325
Lead Sponsor
Washington University School of Medicine
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
84
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group prenatal careGroup 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.
Primary Outcome Measures
NameTimeMethod
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure37-39 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.

Secondary Outcome Measures
NameTimeMethod
effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scalebaseline and 4-12 weeks postpartum

Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale

Birthweightdelivery admission

Determine the effect of group prenatal care on birthweight

effect of group prenatal care on perceived social support as assessed by the Social Support Scale37-39 weeks

Determine the effect of group prenatal care on perceived social support through the Social Support Scale

Contraception4-12 weeks postpartum

Determine the effect of group prenatal care on initiating contraception

Gestational age at deliverydelivery admission

Determine the effect of group prenatal care on preterm delivery

Mean 3rd trimester fasting blood glucosebaseline through delivery

Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose

Breastfeeding4-12 weeks postpartum

Determine the effect of group prenatal care on initiating breastfeeding

Trial Locations

Locations (2)

Washington University in St. Louis

🇺🇸

Saint Louis, Missouri, United States

Denver Health

🇺🇸

Denver, Colorado, United States

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