Diabetes Group Prenatal Care

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Type 2 Diabetes; Gestational Diabetes
• Intervention / Treatment: Behavioral: Group prenatal care

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver Health
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Prenatal Care; 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.
Experimental: Group prenatal care; 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.	Behavioral: Group prenatal care; Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	37-39 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	37-39 weeks
Birthweight	Determine the effect of group prenatal care on birthweight	delivery admission
Gestational age at delivery	Determine the effect of group prenatal care on preterm delivery	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	baseline through delivery
Breastfeeding	Determine the effect of group prenatal care on initiating breastfeeding	4-12 weeks postpartum
Contraception	Determine the effect of group prenatal care on initiating contraception	4-12 weeks postpartum

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Denver Health Medical Center
• Investigators: Study Director: Methodius G Tuuli, MD, MPH, Assistant Professor, Washington University in St. Louis

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): July 6, 2017
• Study Completion (Actual): September 27, 2017

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: diabetes; CenteringPregnancy; group prenatal care
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 201503174