Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT07261956
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 202}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2025-08-24', 'studyFirstSubmitQcDate': '2025-11-29', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Ultrasound evaluation', 'timeFrame': 'One evaluation at admission, another one just before delivery and a final one 24 hours after delivery', 'description': 'Three or more B Lines in at least two lung zones using lung ultrasound'}], 'secondaryOutcomes': [{'measure': 'Dyspnea', 'timeFrame': 'Report of the symptom by the patient from admission for up to three days', 'description': 'Subjective sensation of difficulty breathing'}, {'measure': 'Tachypnea', 'timeFrame': 'Report of the symptom from admission for up to three days.', 'description': 'Respiratory rate above 20 breaths/min'}, {'measure': 'Oxygen saturation', 'timeFrame': 'Report of the value measured by a pulse oxymeter from admission for up to three days', 'description': 'Oxygen saturation measured by pulse oxymeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary edema', 'Severe preeclampsia', 'B lines', 'Lung ultrasound'], 'conditions': ['Pulmonary Edema - Acute', 'Preeclampsia']}, 'descriptionModule': {'briefSummary': 'This research aims to evaluate the usefulness of lung ultrasound (LUS) for detecting and monitoring fluid overload in patients with severe preeclampsia. Severe preeclampsia is a leading cause of maternal death and illness worldwide, often causing fluid buildup that can lead to a serious complication called pulmonary edema, especially after delivery.\n\nThe study will be a prospective, longitudinal observational study with a diagnostic validation component. It will involve patients with a diagnosis of severe preeclampsia who meet specific inclusion criteria. Each participant will undergo a clinical exam and a lung ultrasound, which will assess eight zones of the lungs. The total number of B-lines-a sign of interstitial edema-will be documented.\n\nData will be collected at three key times: upon admission, in the immediate postpartum period (within 24 hours of delivery), and 7-10 days postpartum. The results from the LUS will be compared to clinical signs like shortness of breath, rapid breathing, crackling sounds in the lungs, and oxygen saturation levels.\n\nThe expected impact of this research is to provide evidence that LUS is a valuable, non-invasive, and accessible tool for the early detection of pulmonary congestion in patients with severe preeclampsia. This could lead to improved clinical decision-making and a reduction in maternal respiratory complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preeclampsia with severe features.\n* Gestational age 24 weeks - 41 weeks.\n\nExclusion Criteria:\n\n* Chronic lung disease.\n* Known heart disease.\n* Diagnosis of lung edema at admission\n* Body mass index \\> 40\n* Need for immediate delivery'}, 'identificationModule': {'nctId': 'NCT07261956', 'briefTitle': 'Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Usefulness of Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia', 'orgStudyIdInfo': {'id': '4377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe preeclampsia', 'description': 'Pregnant subjects (24 weeks - 41 weeks) with severe preeclampsia', 'interventionNames': ['Diagnostic Test: Lung ultrasound']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Lung ultrasounf at three moments (at admission, before delivery and immediate post partum) to determine B Lines', 'armGroupLabels': ['Severe preeclampsia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'status': 'RECRUITING', 'country': 'Panama', 'contacts': [{'name': 'Osvaldo A Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es', 'phone': 'o11(507)65655041'}], 'facility': 'Saint Thomas Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Anna C Figueroa, MD', 'role': 'CONTACT', 'email': 'annacfigue@gmail.com', 'phone': '+507 69494250'}, {'name': 'Adriana Martinz, MD', 'role': 'CONTACT', 'email': 'amartinzmd@gmail.com'}], 'overallOfficials': [{'name': 'Osvaldo Reyes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saint Thomas Hospital, Panama'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research Department', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}