NCT00585676

Brief Summary

It is known that administration of steroids increases blood sugar levels. Administration of betamethasone is common practice during pregnancy to women at risk for preterm delivery. However, it is unknown the magnitude of the changes in glucose these women have after receiving betamethasone. The purpose of this study is to determine the magnitude and timing of the increase in blood sugar in pregnant women without diabetes who receive steroids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3.5 years

First QC Date

January 2, 2008

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Area under the curve of blood glucose

    5 days

Study Arms (3)

Diabetic

Patients with Diabetes

Abnormal glucose level

Patients who were screened and had abnormal blood glucose levels

Control

Non-diabetic (normal glucose screening)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women receiving corticosteroids

You may qualify if:

  • Candidates for antenatal corticosteroids (including gestational age between 24-34 weeks)

You may not qualify if:

  • Age less than 18 years
  • Pre-existing maternal corticosteroid or beta-mimetic tocolytic use
  • Pre-gestational diabetes mellitus, class C or greater
  • Pre-existing adrenal or pancreatic dysfunction
  • Evidence of infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michael P Nageotte, MD

    Miller Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Maternal-Fetal Medicine

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 3, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations