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Completed

NCT Number: NCT00295256

Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

The management of high-risk pregnancies require substantial use of medical resources. Our goal is to determine the effectiveness of a nurse case management program in which case managers are assigned to patients with high-risk conditions.

Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a nurse case manager will have lower glucose levels and lower blood pressure levels

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Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Delivery Urogenital Diseases Vascular Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

About this study

We will recruit 50 women for each arm of the study. We we conduct a stratified randomization (by disease) in which women are randomized to a nurse case manager who provides on-going face-to-face contact compared to women who are assigned to a case manager with telephone contact only.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease

Exclusion criteria

  • No telephone; ability to provide consent; english-speaking

Treatment and study plan

nurse case manager

Behavioral

Primary outcomes

  1. Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 23, 2006
Registry last updated
Dec 7, 2017

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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