Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-27 @ 12:06 PM
Study NCT ID:
NCT06898034
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1725}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound exam: uterine measurements', 'timeFrame': 'From enrollment to 1.5-2 hours post partum', 'description': '* Uterine length (cm)\n* Uterine width (cm)\n* Uterine height (cm)\n\nThese will be correlated with subsequent clinical outcomes, including bleeding events.'}, {'measure': 'Ultrasound exam: endometrial stripe', 'timeFrame': 'From enrollment to 1.5-2 hours post partum', 'description': 'Width (cm) of the endometrial stripe (measuring displacement of the uterine walls by intrauterine contents (blood, clots, retained placental fragments or other) to include Doppler study) at 3 levels:\n\n* Fundal\n* Lower uterine segment\n* Cervix\n\nThese will be correlated with subsequent clinical outcomes, including bleeding events.'}, {'measure': 'Ultrasound exam:fibroids', 'timeFrame': 'From enrollment to 1.5-2 hours post partum', 'description': 'Presence of uterine fibroids (number and size in cm of each)\n\nThese will be correlated with subsequent clinical outcomes, including bleeding events.'}, {'measure': 'Ultrasound exam: Vagina', 'timeFrame': 'From enrollment to 1.5-2 hours post partum', 'description': 'Caliber of the vagina (cm) (to assess distension by clot)\n\nThese will be correlated with subsequent clinical outcomes, including bleeding events.'}, {'measure': 'Ultrasound exam: Bladder', 'timeFrame': 'From enrollment to 1.5-2 hours post partum', 'description': '* Bladder length (cm)\n* Bladder height (cm)\n* Bladder width (cm)\n\nAll other aspects of clinical management will be left to the discretion of the clinical team.\n\nThese will be correlated with subsequent clinical outcomes, including bleeding events.'}], 'secondaryOutcomes': [{'measure': 'Chart review', 'timeFrame': 'From enrollment to 6 weeks post partum', 'description': 'Outcome measures for this study will include details about the postpartum course up to 6 weeks postpartum. This will allow correlation with the results of the ultrasound exam. If patients are re-admitted to the hospital after the delivery discharge, investigators will also collect relevant information about those admissions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Post Partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Up to 5% of patients in the United States have a postpartum hemorrhage. "Postpartum hemorrhage" means excessive bleeding after delivery. The majority of these bleeds occur immediately with delivery.\n\nThe current study focuses on hemorrhages that occur in the "medium-term" (1.5-24 hours after delivery). Investigators are examining whether ultrasound exams performed at the beginning of this period 1.5 to 2 hours after birth can identify markers that predict a medium-term bleed. Data collected for this study will include medical and obstetrical history, details about the course and outcomes of patients\' labor and delivery, and particulars about postpartum bleeding. This information will be collected through the end of the patients\' delivery admission and will allow correlation with the results of the ultrasound exam. If patients are re-admitted to the hospital after the delivery discharge, investigators may also collect relevant information about those admissions up to 6 weeks postpartum.\n\nAll patients after term delivery (≥ 37 weeks\' gestation) will be eligible to participate. Patients will be approached to provide consent for participation as early as feasible during a prenatal visit (≥ 36 weeks\' gestation) or during the delivery admission. No subjects will be consented while in significant pain, \\>6cm dilated without an epidural, or \\>8cm dilatated with an epidural.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients admitted to Labor and Delivery for term delivery at Evanston, Highland Park or Swedish Hospitals (≥ 37 weeks' gestation at any maternal age, not decisionally impaired) will be eligible to participate.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently pregnant and planning to deliver at Endeavor Health \\>37 weeks gestational age\n* English speaking\n* Labor \\<6cm dilated at time of consent without epidural\n* Labor \\<8cm dilated at time of consent with epidural\n\nExclusion Criteria:\n\n* Preterm delivery\n* Non-English speaking\n* Any conditions that impairs potential participants decision making'}, 'identificationModule': {'nctId': 'NCT06898034', 'briefTitle': 'Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Endeavor Health'}, 'officialTitle': 'Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage', 'orgStudyIdInfo': {'id': 'STUDY00000080'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound', 'type': 'OTHER', 'description': 'Postpartum ultrasound exam'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emmet Hirsch, MD', 'role': 'CONTACT', 'email': 'EHirsch@northshore.org', 'phoneExt': '(847)570-2222'}], 'facility': 'Endeavor Health', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}], 'centralContacts': [{'name': 'Kate Honeyfield', 'role': 'CONTACT', 'email': 'KHoneyfield@northshore.org', 'phone': '847-570-2243'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endeavor Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emmet Hirsch', 'investigatorAffiliation': 'Endeavor Health'}}}}