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Clinical Trials/NCT02444325
NCT02444325
Completed
N/A

Group Prenatal Care for Women With Diabetes: A Pilot Randomized Control Trial

Washington University School of Medicine2 sites in 1 country84 target enrollmentMay 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Washington University School of Medicine
Enrollment
84
Locations
2
Primary Endpoint
effect of group prenatal care on maternal diabetes self-care activities as measured Diabetes Self-Care Activities Measure
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
September 27, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale(baseline and 4-12 weeks postpartum)
  • Birthweight(delivery admission)
  • effect of group prenatal care on perceived social support as assessed by the Social Support Scale(37-39 weeks)
  • Contraception(4-12 weeks postpartum)
  • Gestational age at delivery(delivery admission)
  • Mean 3rd trimester fasting blood glucose(baseline through delivery)
  • Breastfeeding(4-12 weeks postpartum)

Study Sites (2)

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