Diabetes Group Prenatal Care

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444325
• Other study ID #: 201503174
• Status: Completed
• Phase: N/A
• First received: April 27, 2015
• Last updated: January 3, 2018
• Start date: May 2015
• Est. completion date: September 27, 2017

Study information

• Verified date: January 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 27, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy
• Type 2 Diabetes

Intervention

Behavioral:
• Group prenatal care
Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Denver Health Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Birthweight	Determine the effect of group prenatal care on birthweight	delivery admission
Secondary	Gestational age at delivery	Determine the effect of group prenatal care on preterm delivery	delivery admission
Secondary	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
Secondary	Breastfeeding	Determine the effect of group prenatal care on initiating breastfeeding	4-12 weeks postpartum
Secondary	Contraception	Determine the effect of group prenatal care on initiating contraception	4-12 weeks postpartum