<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03266133</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17050233</org_study_id>
    <nct_id>NCT03266133</nct_id>
  </id_info>
  <brief_title>Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes</brief_title>
  <official_title>Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot randomized controlled trial involving a sleep education intervention in women&#xD;
      with gestational diabetes to study whether sleep education during pregnancy leads to&#xD;
      improvement in glycemic control in women with gestational diabetes and improvement in sleep&#xD;
      duration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal&#xD;
      Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients&#xD;
      with gestational diabetes will be recruited following general education regarding gestational&#xD;
      diabetes in pregnancy which is universally done for all patients at the time of their&#xD;
      diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual&#xD;
      care vs. sleep education program).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>3-6 months during pregnancy</time_frame>
    <description>Proportion of participants achieving glycemic control at study end. Glycemic control defined as greater than 75% of weeks with average fasting blood glucose &lt; 95 mg/dL and 1-hr postprandial blood glucose &lt;140 mg/dL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported sleep duration</measure>
    <time_frame>3-6 months during pregnancy</time_frame>
    <description>Proportion of patients who report sleeping between 7-9 hours per night</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average fasting glucose values</measure>
    <time_frame>3-6 months during pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average postprandial glucose values</measure>
    <time_frame>3-6 months during pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational age at delivery</measure>
    <time_frame>Time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal birth weight</measure>
    <time_frame>Time of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication for delivery</measure>
    <time_frame>Time of delivery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Route of delivery</measure>
    <time_frame>Time of delivery</time_frame>
    <description>Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preeclampsia</measure>
    <time_frame>Time of delivery</time_frame>
    <description>Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Sleep Education Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Education for Pregnancy</intervention_name>
    <description>Sleep education specific to pregnancy</description>
    <arm_group_label>Sleep Education Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant female&#xD;
&#xD;
          2. Ages 18-50&#xD;
&#xD;
          3. Gestational age between 16 0/7 weeks and 31 6/7 weeks&#xD;
&#xD;
          4. New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the&#xD;
             time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children less than 18 years of age&#xD;
&#xD;
          2. Non-English speaking&#xD;
&#xD;
          3. Multiple gestations (twins, triplets, etc)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roxanna Twedt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Fellow, Division of Maternal-Fetal Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27926645</PMID>
  </reference>
  <reference>
    <citation>Twedt 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.</citation>
    <PMID>26241422</PMID>
  </reference>
  <reference>
    <citation>Facco 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.</citation>
    <PMID>20510182</PMID>
  </reference>
  <reference>
    <citation>Qiu 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.</citation>
    <PMID>20470416</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Roxanna Twedt</investigator_full_name>
    <investigator_title>Graduate Medical Fellow</investigator_title>
  </responsible_party>
  <keyword>Gestational Diabetes Mellitus</keyword>
  <keyword>Sleep education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03266133
org study id: PRO17050233
nct id: NCT03266133
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic control
time frame: 3-6 months during pregnancy
description: 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.
measure: Self-reported sleep duration
time frame: 3-6 months during pregnancy
description: Proportion of patients who report sleeping between 7-9 hours per night
measure: Average fasting glucose values
time frame: 3-6 months during pregnancy
measure: Average postprandial glucose values
time frame: 3-6 months during pregnancy
measure: Gestational age at delivery
time frame: Time of delivery
measure: Neonatal birth weight
time frame: Time of delivery
measure: Indication for delivery
time frame: Time of delivery
description: 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.
measure: Route of delivery
time frame: Time of delivery
description: Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.
measure: Preeclampsia
time frame: Time of delivery
description: Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.
arm group label: Sleep Education Intervention
arm group type: Experimental
description: 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.
arm group label: Routine Care
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Sleep Education for Pregnancy
description: Sleep education specific to pregnancy
arm group label: Sleep Education Intervention
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Roxanna Twedt, MD
role: Principal Investigator
affiliation: Clinical Fellow, Division of Maternal-Fetal Medicine
facility: 
country: United States
citation: 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.
PMID: 27926645
citation: Twedt 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.
PMID: 26241422
citation: Facco 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.
PMID: 20510182
citation: Qiu 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.
PMID: 20470416
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Roxanna Twedt
investigator title: Graduate Medical Fellow
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No