Pregnancy Complications
Conditions
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.
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.
Interventions
DEVICEDexcom 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.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | 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
| Measure | Time frame |
|---|---|
| Neonatal Hypoglycemia | birth to discharge |
Countries
United States
Participant flow
Recruitment details
Women receiving clinically indicated betamethasone between 24 and 34 weeks of pregnancy were recruited from the labor and delivery setting.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Data are available for 15 of 17 participants. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Threatened Pre Term Labor Patients |
|---|---|
| Age, Continuous | 30 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gestational age at enrollment | 29.29 weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
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)
Time frame: 24-48 hours post betamethasone treatment
Population: Seventeen women were enrolled at the time of betamethasone administration and data were available for 15 patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Non-Diabetic Threatened Pre Term Labor Patients | Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | mean (SD)% time with blood glucose > 110 | 73 percentage time | Standard Deviation 6 |
| Non-Diabetic Threatened Pre Term Labor Patients | Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | mean (SD)% time with blood glucose > 144 | 40 percentage time | Standard Deviation 17 |
| Non-Diabetic Threatened Pre Term Labor Patients | Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | mean (SD)% time with blood glucose > 180 | 17 percentage time | Standard Deviation 13 |
| Diabetic Threatened Pre Term Labor Patients | Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | mean (SD)% time with blood glucose > 110 | 79 percentage time | Standard Deviation 20 |
| Diabetic Threatened Pre Term Labor Patients | Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | mean (SD)% time with blood glucose > 144 | 58 percentage time | Standard Deviation 26 |
| Diabetic Threatened Pre Term Labor Patients | Percentage Time Spent Above Glucose Thresholds (>110;>144;>180) 24-48 Hours Post Betamethasone Treatment | mean (SD)% time with blood glucose > 180 | 24 percentage time | Standard Deviation 13 |
Secondary
Neonatal Hypoglycemia
Time frame: birth to discharge
Population: Neonates from birth to discharge. The maternal patients received betamethasone to minimize the complications of prematurity. Maternal blood glucose levels were monitored using the Dexcom Seven Plus Continuous Glucose Monitoring System.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-Diabetic Threatened Pre Term Labor Patients | Neonatal Hypoglycemia | Maternal Diabetes | 2 participants |
| Non-Diabetic Threatened Pre Term Labor Patients | Neonatal Hypoglycemia | No Maternal Diabetes | 2 participants |
| Diabetic Threatened Pre Term Labor Patients | Neonatal Hypoglycemia | Maternal Diabetes | 2 participants |
| Diabetic Threatened Pre Term Labor Patients | Neonatal Hypoglycemia | No Maternal Diabetes | 4 participants |
| Neonates With Unknown Hypoglycemia Status | Neonatal Hypoglycemia | Maternal Diabetes | 0 participants |
| Neonates With Unknown Hypoglycemia Status | Neonatal Hypoglycemia | No Maternal Diabetes | 5 participants |
p-value: 0.2155Chi-squared