Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-09 @ 2:28 PM
Study NCT ID:
NCT03266133
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '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', 'timeFrame': '3-6 months during pregnancy', 'description': 'Proportion of patients who report sleeping between 7-9 hours per night'}], 'secondaryOutcomes': [{'measure': 'Average fasting glucose values', 'timeFrame': '3-6 months during pregnancy'}, {'measure': 'Average postprandial glucose values', 'timeFrame': '3-6 months during pregnancy'}, {'measure': 'Gestational age at delivery', 'timeFrame': 'Time of delivery'}, {'measure': 'Neonatal birth weight', 'timeFrame': 'Time of delivery'}, {'measure': 'Indication for delivery', 'timeFrame': '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', 'timeFrame': 'Time of delivery', 'description': 'Medical records will be reviewed to determine if the patient had a vaginal delivery or cesarean delivery.'}, {'measure': 'Preeclampsia', 'timeFrame': 'Time of delivery', 'description': 'Medical records will be reviewed to determine whether a patient had a diagnosis of preeclampsia prior to delivery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gestational Diabetes Mellitus', 'Sleep education'], 'conditions': ['Gestational Diabetes Mellitus in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '27926645', 'type': 'BACKGROUND', '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': '26241422', 'type': 'BACKGROUND', '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': '20510182', 'type': 'BACKGROUND', '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': '20470416', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant female\n2. Ages 18-50\n3. Gestational age between 16 0/7 weeks and 31 6/7 weeks\n4. New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment\n\nExclusion Criteria:\n\n1. Children less than 18 years of age\n2. Non-English speaking\n3. Multiple gestations (twins, triplets, etc)'}, 'identificationModule': {'nctId': 'NCT03266133', 'briefTitle': 'Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes', 'orgStudyIdInfo': {'id': 'PRO17050233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Education Intervention', '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.', 'interventionNames': ['Behavioral: Sleep Education for Pregnancy']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Care', 'description': 'Usual care'}], 'interventions': [{'name': 'Sleep Education for Pregnancy', 'type': 'BEHAVIORAL', 'description': 'Sleep education specific to pregnancy', 'armGroupLabels': ['Sleep Education Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Roxanna Twedt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Fellow, Division of Maternal-Fetal Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Medical Fellow', 'investigatorFullName': 'Roxanna Twedt', 'investigatorAffiliation': 'University of Pittsburgh'}}}}