NCT02444325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2015

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

April 27, 2015

Last Update Submit

January 3, 2018

Conditions

PregnancyGestational DiabetesType 2 Diabetes

Keywords

group prenatal careCenteringPregnancydiabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • effect of group prenatal care on perinatal mood as measured by 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

    37-39 weeks

  • Birthweight

    delivery admission

  • Gestational age at delivery

    delivery admission

  • Mean 3rd trimester fasting blood glucose

    baseline through delivery

  • +2 more secondary outcomes

Study Arms (2)

Routine Prenatal Care

NO INTERVENTION

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.

Group prenatal care

EXPERIMENTAL

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

Interventions

Group prenatal careBEHAVIORAL

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

Group prenatal care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver Health

Denver, Colorado, 80204, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Methodius G Tuuli, MD, MPH

    Assistant Professor, Washington University in St. Louis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 14, 2015

Study Start

May 1, 2015

Primary Completion

July 6, 2017

Study Completion

September 27, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

US(2)