Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University
ClinicalTrials.gov Identifier:
NCT01165775
First received: July 16, 2010
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

We hope to clarify how betamethasone affects glucose levels in the mother in the days after receiving the drug. This understanding will hopefully allow us to better anticipate the risk of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal glucose to prevent maternal and neonatal complications of hyperglycemia.


Condition Intervention
Pregnancy Complications
Device: Dexcom Seven Plus Continuous Glucose Monitoring System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Episodes of hyperglycemia [ Time Frame: 7 days from insertion of device ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neonatal hypoglycemia [ Time Frame: 2 da ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Threatened pre term labor patients
Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.
Device: Dexcom Seven Plus Continuous Glucose Monitoring System
Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.

Detailed Description:

Pregnant patients who are undergoing inpatient betamethasone therapy as part of their clinical care will be eligible for the study. Once the clinical team and patients have agreed to pursue betamethasone therapy, the patients' treating physician or nurse will inquire if the patient is interested in participating in our study protocol. Those patients who are interested in participation will be consented by either a member of the treatment team or the study team. Prior to receiving the first betamethasone dose, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. For those patients who will be receiving a scheduled course of betamethasone, the sensor may be inserted up to 24 hours prior to the betamethasone administration. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for the duration of her hospitalization or for up to 7 days total, whichever time period is shorter. For those patients who are diabetic, they will receive normal finger stick blood glucose (FSBG) monitoring and insulin therapy as determined by their treating physicians. Those patients who are not diabetic will need to have 2 FSBG checks each day to correlate with the device. Abnormal values will be reported to the patients' treating physician and addressed by the treating physician. Prior to being discharged from the hospital, the patient will have the device removed. The patient will otherwise be treated routinely. We will record baseline demographic information and medical history from each of the women. We will also record information from the neonates' newborn medical records.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women receiving betamethasone

Criteria

Inclusion Criteria:- 18 years of age or older

  • Receiving betamethasone as part of routine clinical care.
  • Pregnancy between 23+5 and 35+0 weeks

Exclusion Criteria:- Less than 18 years old.

  • Major fetal anomalies
  • Use of steroid medications in the past 2 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165775

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Yasser Yehia El-Sayed Stanford University
  More Information

No publications provided

Responsible Party: Yasser Yehia El-Sayed, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01165775     History of Changes
Other Study ID Numbers: SU-07082010-6490, 18962
Study First Received: July 16, 2010
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pregnancy Complications
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 22, 2014