Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-14 @ 8:39 AM
Study NCT ID:
NCT02756403
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2016-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peggy.ye@medstar.net', 'phone': '202-877-7479', 'title': 'Principal Investigator', 'organization': 'MedStar Washington Hospital Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One week', 'description': 'Patients involved in study were called on telephone at one week to assess for any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Metronidazole', 'description': 'Patients receivingMetronidazole for preprocedure antibiotic', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Azithromycin', 'description': 'Patients receiving Azithromycin for preprocedure antibiotic', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Doxycycline', 'description': 'Patients receiving Doxycycline for preprocedure antibiotic', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Patients receiving Placebo preprocedure', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Inpatient Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nausea Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'OG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'OG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Inactive Ingredient\n\nPlacebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'None', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Before Procedure', 'categories': [{'title': 'None', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'After Procedure', 'categories': [{'title': 'None', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': 'Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Emesis Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'OG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'OG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Inactive Ingredient\n\nPlacebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Before Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Day', 'description': 'Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '4 Subjects failed to complete the entire post-procedure survey: 1 Azithromycin group, 2 in Metronidazole group, 1 in Placebo group'}, {'type': 'SECONDARY', 'title': 'Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'OG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'OG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Inactive Ingredient\n\nPlacebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.'}], 'classes': [{'title': 'Baseline Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Before Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'After Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}, {'title': 'Mild', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}, {'title': 'Moderate', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}, {'title': 'Severe', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Pain symptoms will be collected at different time points via surveys (None, Mild, Moderate, Severe)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients had incomplete post-procedure surveys: 1 in Azithromycin group, 2 in Metronidazole group, 1 in Placebo group'}, {'type': 'SECONDARY', 'title': 'Serum Antibiotic Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'OG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'OG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.41', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hours', 'description': 'Serum antibiotic levels drawn at time of endometrial sampling in subset of patients', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients who had serum antibiotic levels drawn'}, {'type': 'SECONDARY', 'title': 'Endometrial Growth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'OG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'OG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Inactive Ingredient\n\nPlacebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.'}], 'classes': [{'title': 'No Growth', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Trypic Soy Non-Selective Agar', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Mannitol Salt Agar (Staph selective)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Streptococcus Agar (Strep selective)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'MacConkey Agar (gram neg selective)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Days', 'description': 'Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with endometrial swab cultured'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'FG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'FG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Inactive Ingredient\n\nPlacebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Unable to swallow medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Did not complete Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Changed Mind About Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin', 'description': '500 mg of Azithromycin\n\nAzithromycin: 500 mg'}, {'id': 'BG001', 'title': 'Doxycycline', 'description': '200 mg of Doxycycline\n\nDoxycycline: 200 mg'}, {'id': 'BG002', 'title': 'Metronidazole', 'description': '500 mg of Metronidazole\n\nMetronidazole: 500 mg'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Inactive Ingredient\n\nPlacebo: Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '26.2', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '28.6', 'spread': '6.1', 'groupId': 'BG003'}, {'value': '26.6', 'spread': '5.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '27.8', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '27.0', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '29.0', 'spread': '7.0', 'groupId': 'BG003'}, {'value': '28.3', 'spread': '7.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow. Unable to measure height/weight for one immobilized patient (metronidazole group)'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Less than High School', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'HS Grad or Equivalent', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}, {'title': 'Some College', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}, {'title': 'College Grad', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Graduate School', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'Parous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Nulliparous', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'Parous', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'Marital Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Single', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'Married', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': 'Divorced', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Separated', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Cohabitating', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'Work Status', 'classes': [{'title': 'Full Time Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}, {'title': 'Part Time Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}, {'title': 'Full Time Student', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Unemployed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}, {'title': 'Homemaker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow.\n\nSeveral patients indicated multiple answers'}, {'title': 'Prior Abortion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}, {'title': 'Gestational age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '60.9', 'spread': '16.8', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '65', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '67.5', 'spread': '15.8', 'groupId': 'BG003'}, {'value': '64.3', 'spread': '15.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'at time of procedure, by ultrasound criteria', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Excluded protocol violations and patients unable to complete study, see Patient Flow'}], 'populationDescription': '2 Patients excluded for protocol violations, 2 withdrawn due to cancelled Abortion procedures, 3 withdrawn as unable to tolerate study medications.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-26', 'size': 209122, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-16T23:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2016-03-20', 'resultsFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2016-04-27', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-10', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nausea Scale', 'timeFrame': '1 Day', 'description': 'Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)'}, {'measure': 'Emesis Severity', 'timeFrame': '1 Day', 'description': 'Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)'}], 'secondaryOutcomes': [{'measure': 'Pain Scale', 'timeFrame': 'Day 1', 'description': 'Pain symptoms will be collected at different time points via surveys (None, Mild, Moderate, Severe)'}, {'measure': 'Serum Antibiotic Levels', 'timeFrame': '3 hours', 'description': 'Serum antibiotic levels drawn at time of endometrial sampling in subset of patients'}, {'measure': 'Endometrial Growth', 'timeFrame': '3 Days', 'description': 'Endometrial Growth on non-selective, Staph Selective, Strep Selective, and Gram negative selective Agar'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['First Trimester Abortion']}, 'descriptionModule': {'briefSummary': 'This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures.\n\nIn total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three commonly used antibiotics (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior to their abortion procedure. Approximately, 30-60 mins after study drug administration, the procedure will be performed.\n\nA sub-study will be completed on 40 women who consent to endometrial sampling and to have their blood drawn.', 'detailedDescription': 'Main Study:\n\nWomen will be randomized to receive single oral doses of azithromycin 500 mg, doxycycline 200 mg, metronidazole 500 mg, or placebo. Computer-generated randomization will be used to assign participants to one of the four treatment arms. Women receiving placebo will receive antibiotic prophylaxis after completion of the study.\n\nBoth the participants and the investigators will be blinded as to the treatment group. This will be accomplished by placing the study medication inside opaque gelatin capsules. We will randomize participants by assigning them to the next of the sequentially numbered sealed opaque study packets, containing the gelatin capsules with study medication inside. A second envelope will be opened after completion of all study procedure and will only say if the participant received placebo, so that additional antibiotics can be given.\n\nParticipants will swallow the appropriate medication approximately 30-60 minutes prior to the surgical abortion (15-90 minutes range is acceptable). Study population will be all eligible patients undergoing surgical abortion in the first trimester at Washington Hospital Center and Planned Parenthood Metropolitan Washington. We will assess pain and side effects via written questionnaire at three different time points throughout the day, once at time of consent, before and after the procedure. Patients will be contacted within 1-2 weeks for follow-up and again pain and side effects will be assessed, as well.\n\nSub-study:\n\nForty (n=40) women will be recruited to undergo immediate post-procedure endometrial sampling. Sub-study patients will have a blood sample collected via venipuncture before leaving the procedure room, as well. No testing will be performed for participants receiving placebo.\n\nThe primary objective is to determine if the side effects associated with individual medications are more similar to placebo than the others.\n\nThe sub-study aims to explore our ability to identify bacteria within the uterine cavity. The objective is to assess the feasibility of identifying bacteria within the uterus after abortion.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women in good general health.\n* English speaking.\n* Age 18 or over.\n* Seeking non-urgent surgical termination of pregnancy.\n* Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.\n\nExclusion Criteria:\n\n* Less than 18 years of age.\n* Early pregnancy failure or fetal demise.\n* Poor general health that would prevent one from tolerating the medication or surgical procedure.\n* Intolerance, allergy, or contraindication to any of the study medications.\n* Inability to tolerate oral intake due to current nausea or vomiting.\n* Diagnosis of hyperemesis gravidarum with current pregnancy.\n* Need of an urgent surgical abortion.\n* Gestational age outside of 5-13 6/7 weeks by sonogram.'}, 'identificationModule': {'nctId': 'NCT02756403', 'briefTitle': 'A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'A Randomized Controlled Trial of Three Prophylactic Antibiotic Regimens for First Trimester Surgical Abortion', 'orgStudyIdInfo': {'id': '2015-159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Azithromycin', 'description': '500 mg of Azithromycin', 'interventionNames': ['Drug: Azithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': '200 mg of Doxycycline', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metronidazole', 'description': '500 mg of Metronidazole', 'interventionNames': ['Drug: Metronidazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inactive Ingredient', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Azithromycin', 'type': 'DRUG', 'description': '500 mg', 'armGroupLabels': ['Azithromycin']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': '200 mg', 'armGroupLabels': ['Doxycycline']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': '500 mg', 'armGroupLabels': ['Metronidazole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20910', 'city': 'Silver Spring', 'state': 'Maryland', 'country': 'United States', 'facility': 'Planned Parenthood Metropolitan Washington', 'geoPoint': {'lat': 38.99067, 'lon': -77.02609}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}