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Completed

NCT Number: NCT02444325

Diabetes Group Prenatal Care

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.

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Key information

Conditions

Pregnancy Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Type 2 Diabetes Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group prenatal care

Behavioral

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

Primary outcomes

  1. 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

  1. effect of group prenatal care on perinatal mood as measured by Edinburgh Postnatal Depression Scale

    Time frame: baseline and 4-12 weeks postpartum

    Determine the effect of group prenatal care on perinatal mood as measured by the Edinburgh Postnatal Depression Scale

  2. effect of group prenatal care on perceived social support as assessed by the Social Support Scale

    Time frame: 37-39 weeks

    Determine the effect of group prenatal care on perceived social support through the Social Support Scale

  3. Birthweight

    Time frame: delivery admission

    Determine the effect of group prenatal care on birthweight

  4. Gestational age at delivery

    Time frame: delivery admission

    Determine the effect of group prenatal care on preterm delivery

  5. Mean 3rd trimester fasting blood glucose

    Time frame: baseline through delivery

    Determine the effect of group prenatal care on maternal glycemic control through mean 3rd trimester fasting glucose

  6. Breastfeeding

    Time frame: 4-12 weeks postpartum

    Determine the effect of group prenatal care on initiating breastfeeding

  7. Contraception

    Time frame: 4-12 weeks postpartum

    Determine the effect of group prenatal care on initiating contraception

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Denver Health Medical Center

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 14, 2015
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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