Gestational Diabetes Mellitus in PregnancyNCT03266133
Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
A study testing Sleep Education for Pregnancy in people with Gestational Diabetes Mellitus in Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Sleep Education for Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 30 Jun 2019
- Phase
- Interventional
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant female
- Ages 18-50
- Gestational age between 16 0/7 weeks and 31 6/7 weeks
- New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment
Who cannot join
- Children less than 18 years of age
- Non-English speaking
- Multiple gestations (twins, triplets, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.
Read the detailed description
Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual care vs. sleep education program).
- Being tested
- Sleep Education for Pregnancy
- Keywords
- Gestational Diabetes Mellitus, Sleep education
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Education for PregnancyBehavioural
Sleep education specific to pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education Intervention | Experimental | This is a two-session program designed to educate patients about healthy sleep in respect to timing, regularity, efficiency, and duration in order to promote sleep during pregnancy. Receives: Behavioral: Sleep Education for Pregnancy |
| Routine Care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Proportion of participants achieving glycemic control at study end. Glycemic control defined as greater than 75% of weeks with average fasting blood glucose < 95 mg/dL and 1-hr postprandial blood glucose <140 mg/dL.
Measured: 3-6 months during pregnancy
Self-reported sleep duration
Proportion of patients who report sleeping between 7-9 hours per night
Measured: 3-6 months during pregnancy
Secondary outcomes (7)
Average fasting glucose values
Measured: 3-6 months during pregnancy
Average postprandial glucose values
Measured: 3-6 months during pregnancy
Gestational age at delivery
Measured: Time of delivery
Neonatal birth weight
Measured: Time of delivery
Indication for delivery
Medical records will be used to determine whether a patient when into spontaneous labor, had an induction or labor or a recommended delivery by cesarean section. If the patient had an induction or labor or a recommended cesarean delivery, the indication for this recommendation will be recorded.
Measured: Time of delivery
Route of delivery
Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.
Measured: Time of delivery
Preeclampsia
Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.
Measured: Time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start27 Nov 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxanna Twedt, University of Pittsburgh
- Investigators
- Roxanna Twedt, MD, Principal investigator, Clinical Fellow, Division of Maternal-Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266133
- Sponsor's protocol ID
- PRO17050233
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2017
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Facco FL, Parker CB, Reddy UM, Silver RM, Koch MA, Louis JM, Basner RC, Chung JH, Nhan-Chang CL, Pien GW, Redline S, Grobman WA, Wing DA, Simhan HN, Haas DM, Mercer BM, Parry S, Mobley D, Hunter S, Saade GR, Schubert FP, Zee PC. Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus. Obstet Gynecol. 2017 Jan;129(1):31-41. doi: 10.1097/AOG.0000000000001805.
PubMed 27926645Twedt R, Bradley M, Deiseroth D, Althouse A, Facco F. Sleep Duration and Blood Glucose Control in Women With Gestational Diabetes Mellitus. Obstet Gynecol. 2015 Aug;126(2):326-331. doi: 10.1097/AOG.0000000000000959.
PubMed 26241422Facco FL, Grobman WA, Kramer J, Ho KH, Zee PC. Self-reported short sleep duration and frequent snoring in pregnancy: impact on glucose metabolism. Am J Obstet Gynecol. 2010 Aug;203(2):142.e1-5. doi: 10.1016/j.ajog.2010.03.041. Epub 2010 May 26.
PubMed 20510182Qiu C, Enquobahrie D, Frederick IO, Abetew D, Williams MA. Glucose intolerance and gestational diabetes risk in relation to sleep duration and snoring during pregnancy: a pilot study. BMC Womens Health. 2010 May 14;10:17. doi: 10.1186/1472-6874-10-17.
PubMed 20470416
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03266133
- Acronym / sponsor ID
- PRO17050233
- Keywords
- Gestational Diabetes Mellitus, Sleep education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.
Detailed description
Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual care vs. sleep education program).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Education Intervention | Experimental | Behavioral: Sleep Education for PregnancyThis is a two-session program designed to educate patients about healthy sleep in respect to timing, regularity, efficiency, and duration in order to promote sleep during pregnancy. |
| Routine Care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant female
- Ages 18-50
- Gestational age between 16 0/7 weeks and 31 6/7 weeks
- New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment
Key exclusion criteria (3 listed)
- Children less than 18 years of age
- Non-English speaking
- Multiple gestations (twins, triplets, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Education for PregnancySleep education specific to pregnancy | Behavioural | Sleep Education Intervention |
Primary outcome
Glycemic control
Time frame: 3-6 months during pregnancy
Proportion of participants achieving glycemic control at study end. Glycemic control defined as greater than 75% of weeks with average fasting blood glucose < 95 mg/dL and 1-hr postprandial blood glucose <140 mg/dL.
Self-reported sleep duration
Time frame: 3-6 months during pregnancy
Proportion of patients who report sleeping between 7-9 hours per night
7 secondary outcomes
Average fasting glucose values
Time frame: 3-6 months during pregnancy
Average postprandial glucose values
Time frame: 3-6 months during pregnancy
Gestational age at delivery
Time frame: Time of delivery
Neonatal birth weight
Time frame: Time of delivery
Indication for delivery
Time frame: Time of delivery
Route of delivery
Time frame: Time of delivery
Preeclampsia
Time frame: Time of delivery
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 12 Aug 2019.
- Background: PubMed 27926645Facco FL, Parker CB, Reddy UM, Silver RM, Koch MA, Louis JM, Basner RC, Chung JH, Nhan-Chang CL, Pien GW, Redline S, Grobman WA, Wing DA, Simhan HN, Haas DM, Mercer BM, Parry S, Mobley D, Hunter S, Saade GR, Schubert FP, Zee PC. Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus. Obstet Gynecol. 2017 Jan;129(1):31-41. doi: 10.1097/AOG.0000000000001805.
- Background: PubMed 26241422Twedt R, Bradley M, Deiseroth D, Althouse A, Facco F. Sleep Duration and Blood Glucose Control in Women With Gestational Diabetes Mellitus. Obstet Gynecol. 2015 Aug;126(2):326-331. doi: 10.1097/AOG.0000000000000959.
- Background: PubMed 20510182Facco FL, Grobman WA, Kramer J, Ho KH, Zee PC. Self-reported short sleep duration and frequent snoring in pregnancy: impact on glucose metabolism. Am J Obstet Gynecol. 2010 Aug;203(2):142.e1-5. doi: 10.1016/j.ajog.2010.03.041. Epub 2010 May 26.
- Background: PubMed 20470416Qiu C, Enquobahrie D, Frederick IO, Abetew D, Williams MA. Glucose intolerance and gestational diabetes risk in relation to sleep duration and snoring during pregnancy: a pilot study. BMC Womens Health. 2010 May 14;10:17. doi: 10.1186/1472-6874-10-17.
- Individual participant dataSharing planned: No
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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.
Roxanna Twedt, MD principal investigator
Clinical Fellow, Division of Maternal-Fetal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education for Pregnancy in people with Gestational Diabetes Mellitus in Pregnancy, run by University of Pittsburgh at 1 site 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 4 inclusion and 3 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Glycemic control (time frame: 3-6 months during pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266133, which also lists 4 linked publications.
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 12 Aug 2019.