Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT03028194
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003475', 'term': 'Curettage'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '6 hours', 'description': 'Arterial blood pressure'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '12 hours', 'description': 'Arterial blood pressure'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '24 hours', 'description': 'Arterial blood pressure'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '48 hours', 'description': 'Arterial Blood pressure'}], 'secondaryOutcomes': [{'measure': 'Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).', 'timeFrame': '6 hours', 'description': 'Number of patients with an abnormal laboratory value'}, {'measure': 'Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).', 'timeFrame': '12 hours', 'description': 'Number of patients with an abnormal laboratory value'}, {'measure': 'Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).', 'timeFrame': '24 hours', 'description': 'Number of patients with an abnormal laboratory value'}, {'measure': 'Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).', 'timeFrame': '48 hours', 'description': 'Number of patients with an abnormal laboratory value'}, {'measure': 'Seizures', 'timeFrame': '48 hours', 'description': 'Number of participants with the development of seizures after birth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pre-eclampsia', 'Eclampsia', 'Postpartum uterine curettage'], 'conditions': ['Pre-Eclampsia', 'Eclampsia']}, 'descriptionModule': {'briefSummary': 'Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.', 'detailedDescription': 'To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.\n\nA total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 24 weeks or more.\n* Preeclampsia/eclampsia\n\nExclusion Criteria:\n\n* Epilepsy or seizures previous to pregnancy.\n* Renal disease\n* Heart disease\n* Liver disease'}, 'identificationModule': {'nctId': 'NCT03028194', 'briefTitle': 'Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'MHST2014-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curettage', 'description': 'Postpartum uterine curettage performed immediately after delivery of the placenta.', 'interventionNames': ['Procedure: Curettage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'No procedure performed after delivery of the placenta.', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Curettage', 'type': 'PROCEDURE', 'description': 'Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.', 'armGroupLabels': ['Curettage']}, {'name': 'Placebo', 'type': 'PROCEDURE', 'description': 'No procedure after delivery of the placenta', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas H', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas Maternity Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Osvaldo Reyes, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Saint Thomas Hospital, Panama'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Research Department', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}