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OpenTrials
Completed

NCT Number: NCT01165775

Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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)

Secondary outcomes

  1. Neonatal Hypoglycemia

    Time frame: birth to discharge

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2010
Registry last updated
Sep 16, 2016

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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