Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00376493
Status:
TERMINATED
Last Update Posted:
2008-03-13
First Post:
2006-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prolonged Treatment for Infected Abortion After Hospital Discharge.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000031', 'term': 'Abortion, Septic'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D011251', 'term': 'Pregnancy Complications, Infectious'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'The rate of cure in both arms was higher than expected', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-10', 'studyFirstSubmitDate': '2006-09-14', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital re-admission', 'timeFrame': '7 days after hospital discharge'}], 'secondaryOutcomes': [{'measure': 'minimal or absent vaginal bleeding', 'timeFrame': '7 days after hospital discharge'}, {'measure': 'walking normally', 'timeFrame': '7 days after hospital discharge'}, {'measure': 'important decrease of pain', 'timeFrame': '7 days after hospital discharge'}, {'measure': 'no fever', 'timeFrame': '7 days after hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abortion', 'Infection', 'Antibiotics', 'Treatment', 'Pregnancy complications'], 'conditions': ['Septic Abortion']}, 'referencesModule': {'references': [{'pmid': '8022443', 'type': 'BACKGROUND', 'citation': 'Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.'}, {'pmid': '12048413', 'type': 'BACKGROUND', 'citation': 'Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. No abstract available.'}, {'pmid': '9822512', 'type': 'BACKGROUND', 'citation': "Turnquest MA, How HY, Cook CR, O'Rourke TP, Cureton AC, Spinnato JA, Brown HL. Chorioamnionitis: is continuation of antibiotic therapy necessary after cesarean section? Am J Obstet Gynecol. 1998 Nov;179(5):1261-6. doi: 10.1016/s0002-9378(98)70143-7."}, {'pmid': '16085035', 'type': 'BACKGROUND', 'citation': 'Faro S. Postpartum endometritis. Clin Perinatol. 2005 Sep;32(3):803-14. doi: 10.1016/j.clp.2005.04.005.'}, {'pmid': '15495005', 'type': 'BACKGROUND', 'citation': 'French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. doi: 10.1002/14651858.CD001067.pub2.'}, {'pmid': '11304107', 'type': 'BACKGROUND', 'citation': 'Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.'}, {'pmid': '10480822', 'type': 'BACKGROUND', 'citation': 'Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670.'}]}, 'descriptionModule': {'briefSummary': 'Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge.', 'detailedDescription': 'The use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. A recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. The objective of this study is to verify if this finding also applies to infected abortions.\n\nAfter in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. Active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment.\n\nCure will be defined as the absence of fever, pain and bleeding. Failure of treatment will be considered as the need for hospitalization or additional antibiotics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of intrauterine manipulation with contaminated objects.\n* Vaginal secretion with fetid odor\n* Presence of pus flowing through the cervical uterine\n* Presence of peritonitis\n* Leucocytosis (\\> 14,000 leucocytes/mL)\n* Vasodilatation, bounding pulse and paradoxically warm periphery with tachycardia (Heart rate\\> 110 bpm)\n* Cyanosis and/or paleness\n* tachypnea(\\> 30mpm)\n* Arterial hypotension (SAP\\< 90mmHg)\n* Oliguria\n* Fever (\\> or = than 37,8°C)\n\nExclusion Criteria:\n\n* Refusal to participate in the project\n* Prior use of antibiotics within one week\n* Known allergy to Doxycycline or Metronidazole\n* Presence of tubo-ovarian abscess'}, 'identificationModule': {'nctId': 'NCT00376493', 'acronym': 'APA', 'briefTitle': 'Prolonged Treatment for Infected Abortion After Hospital Discharge.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Prolonged Treatment for Infected Abortion After Hospital Discharge.', 'orgStudyIdInfo': {'id': 'APA 05-452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Use of antibiotics after hospital discharge', 'interventionNames': ['Drug: metronidazole and doxycycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Use of placebo', 'interventionNames': ['Drug: metronidazole and doxycycline']}], 'interventions': [{'name': 'metronidazole and doxycycline', 'type': 'DRUG', 'description': 'use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Ricardo F Savaris, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}, {'name': 'Adriani O Galão, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ricardo Francalacci Savaris', 'oldOrganization': 'Hospital de Clínicas de Porto Alegre'}}}}