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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02444325
Other study ID # 201503174
Secondary ID
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
Health authority
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

Study Design


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
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