Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

NCT01165775 | Completed Results

• 2 other identifiers: SU-07082010-649018962
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment

  During a 24 hour monitoring period (24-48 hours post betamethasone treatment), which percentage of the time was spent above glucose thresholds (\>110;\>144;\>180)

  24-48 hours post betamethasone treatment

Secondary Outcomes (1)

• Neonatal Hypoglycemia

  birth to discharge

Study Arms (1)

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

Interventions

Dexcom Seven Plus Continuous Glucose Monitoring System DEVICE

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.

Threatened pre term labor patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women receiving betamethasone

You may qualify if:

• Receiving betamethasone as part of routine clinical care.

You may not qualify if:

• Major fetal anomalies
• Use of steroid medications in the past 2 weeks.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Langen ES, Kuperstock JL, Sung JF, Taslimi M, Byrne J, El-Sayed YY. Maternal glucose response to betamethasone administration. Am J Perinatol. 2015 Feb;30(2):143-8. doi: 10.1055/s-0034-1376387. Epub 2014 Jun 10.

  PMID: 24915559 RESULT

Related Links

• Maternal glucose response to betamethasone administration

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Yasser El-Sayed, MD
• Organization: Stanford School of Medicine

Yasser.el-sayed@stanford.edu

(650) 723-3198

Study Officials

• Yasser Yehia El-Sayed

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 16, 2016
• Results First Posted: September 16, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)