Pregnant WomenNCT00673543
Corticosteroid Therapy on Glucose Control in Pregnant Women With Diabetes
An observational study of Pregnant Women, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who will receive corticosteroid therapy.
Who may be able to join
- The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.
Who cannot join
- Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson Hospital
Houston, Texas, 77026
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, 77030
About this study
Official title: The Effects of Corticosteroid Therapy on Glucose Control in Pregnant Women With Insulin Requiring Diabetes Mellitus
Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.
This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.
Read the detailed description
Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. Although corticosteroid therapy significantly decreases the risk for respiratory distress syndrome in the newborn, such therapy can lead to transient elevations in maternal glucose levels, potentially resulting in life-threatening maternal metabolic abnormalities, low oxygen levels in the fetus, and in extreme cases, stillbirth. Because the elevations in glucose levels may drastically increase over a short period of time, intense monitoring of maternal glucose levels to achieve strict glycemic control and treatment is preferred with the use of insulin. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.
This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.
The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.
Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.
- Conditions
- Pregnant Women
- Keywords
- Corticosteroids, Pregnancy, Glucose control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pregnant women with insulin requiring diabetes | |
| 2 | Pregnant women without insulin requiring diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time point at which glucose elevation occurs after glucocorticoid administration (greater than 50% increase in the patient's baseline blood) glucose level.
Measured: Within 7 days
Secondary outcomes (9)
Time at which glucose normalization occurs (ability to achieve glucose level within 20% of the patient's baseline blood glucose level)
Measured: 7 days
The change in glucose in incremental amounts (every 4, 6, and 8 hour intervals) over time.
Measured: 7 days
The amount of insulin needed to achieve targeted glucose levels over time
Measured: 7 days
Total amount of insulin as well as incremental amounts of insulin every (4, 6, and 8 hour intervals)
Measured: 7 days
Maternal age
Measured: 7 days
Maternal body mass index
Measured: 7 days
Gestational age
Measured: 7 days
Hemoglobin A1C
Measured: 7 days
Pre-corticosteroid insulin amount
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrie Refuerzo, The University of Texas Health Science Center, Houston
- Investigators
- Jerrie S Refuerzo, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673543
- Sponsor's protocol ID
- HSC-MS-08-0074
- Status last verified
- May 2017
- First submitted
- 5 May 2008
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Corticosteroid Therapy on Glucose Control in Pregnant Women With Insulin Requiring Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00673543
- Acronym / sponsor ID
- HSC-MS-08-0074
- Conditions
- Pregnant Women
- Keywords
- Corticosteroids, Pregnancy, Glucose control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.
This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.
Detailed description
Preterm birth occurs in 25% of women with insulin requiring diabetes in pregnancy. The administration of corticosteroid therapy to accelerate fetal lung maturation is indicated in women at risk for preterm birth. Although corticosteroid therapy significantly decreases the risk for respiratory distress syndrome in the newborn, such therapy can lead to transient elevations in maternal glucose levels, potentially resulting in life-threatening maternal metabolic abnormalities, low oxygen levels in the fetus, and in extreme cases, stillbirth. Because the elevations in glucose levels may drastically increase over a short period of time, intense monitoring of maternal glucose levels to achieve strict glycemic control and treatment is preferred with the use of insulin. The purpose of this study is to compare the timing, duration and severity of maternal hyperglycemia after corticosteroid administration in women with insulin-requiring diabetes compared to those without diabetes in pregnancy.
This is a prospective, observational study. Hourly glucose levels will be obtained for a total of 7 days after corticosteroid administration using the Dexcom Seven continuous glucose monitoring system. In addition, hemoglobin A1C will be obtained to assess the overall level of glycemic control of the participant prior to the corticosteroid therapy.
The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.
Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pregnant women with insulin requiring diabetes |
| 2 | – | –Pregnant women without insulin requiring diabetes |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women who will receive corticosteroid therapy.
Key inclusion criteria (1 listed)
- The study group will include pregnant women > 18 years of age with insulin-requiring diabetes who will receive corticosteroid therapy to accelerate fetal lung maturation between 24 and 34 weeks of pregnancy. Only those women not in active labor and with singleton gestations will be included. A control group will be comprised of pregnant women with singleton gestations without insulin-requiring diabetes who will receive corticosteroid therapy also to accelerate fetal lung maturation.
Key exclusion criteria (1 listed)
- Women will be excluded if they have diet controlled diabetes, twins or higher gestation, are in active labor and anticipate imminent delivery, were previously on any form of steroid therapy, or who have or will be receiving beta-adrenergic medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time point at which glucose elevation occurs after glucocorticoid administration (greater than 50% increase in the patient's baseline blood) glucose level.
Time frame: Within 7 days
9 secondary outcomes
Time at which glucose normalization occurs (ability to achieve glucose level within 20% of the patient's baseline blood glucose level)
Time frame: 7 days
The change in glucose in incremental amounts (every 4, 6, and 8 hour intervals) over time.
Time frame: 7 days
The amount of insulin needed to achieve targeted glucose levels over time
Time frame: 7 days
Total amount of insulin as well as incremental amounts of insulin every (4, 6, and 8 hour intervals)
Time frame: 7 days
Maternal age
Time frame: 7 days
Maternal body mass index
Time frame: 7 days
Gestational age
Time frame: 7 days
Hemoglobin A1C
Time frame: 7 days
Pre-corticosteroid insulin amount
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerrie S Refuerzo, M.D. principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time point at which glucose elevation occurs after glucocorticoid administration (greater than 50% increase in the patient's baseline blood) glucose level. (time frame: Within 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.