Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy
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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 |
- Episodes of hyperglycemia [ Time Frame: 7 days from insertion of device ] [ Designated as safety issue: No ]
- Neonatal hypoglycemia [ Time Frame: 2 da ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | June 2012 (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.
|
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 |
Pregnant women receiving betamethasone
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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: | March 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pregnancy Complications Betamethasone-17,21-dipropionate Betamethasone Betamethasone sodium phosphate Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013