Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 12:00 PM
Study NCT ID:
NCT05345457
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D047928', 'term': 'Premature Birth'}], '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': 'D007752', 'term': 'Obstetric Labor, Premature'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery within 28 days', 'timeFrame': '28 days from date of rupture', 'description': 'The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)'}], 'secondaryOutcomes': [{'measure': 'Severe maternal morbidity composite', 'timeFrame': 'From diagnosis of membrane rupture to 6 weeks following delivery', 'description': 'The proportion of patient\'s "positive" for severe maternal morbidity composite. A patient will be termed "positive" for severe maternal morbidity composite if any one of the following is diagnosed: maternal sepsis, postpartum hemorrhage, maternal ICU admission, maternal death.'}, {'measure': 'Severe neonatal morbidity composite', 'timeFrame': 'From date of delivery to date of hospital discharge (up to 6 months)', 'description': 'The proportion of patient\'s "positive" for severe neonatal morbidity composite. A neonate will be termed "positive" for severe neonatal morbidity composite if any one of the following is diagnosis: bronchopulmonary dysplasia (BPD), pulmonary hypoplasia, intraventricular hemorrhage (IVH) grade III/IV, necrotizing enterocolitis (NEC) Bell\'s Stage II or greater, neonatal sepsis with positive blood cultures, neonatal pneumonia with positive blood cultures, neonatal death.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Preterm', 'Pregnancy Prom', 'PROM, Preterm (Pregnancy)', 'PROM (Pregnancy)', 'Premat Rupture Membranes Preterm Unspec to Length of Time Between Rupture/Labor', 'Premature Birth']}, 'referencesModule': {'references': [{'pmid': '24974589', 'type': 'BACKGROUND', 'citation': 'Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. 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Am J Obstet Gynecol. 2000 Jun;182(6):1638-44. doi: 10.1067/mob.2000.107435.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking\n* Pregnant\n* Live, singleton gestation\n* Patient able to provide informed consent\n* Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture\n* Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm\n\nExclusion Criteria:\n\n* Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age\n* Patient desires pregnancy interruption or induction of labor\n* Known major fetal anomaly or aneuploidy\n* Amniocentesis ≤ 7 days of diagnosis of rupture of membranes\n* Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes\n* Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics\n* Current antibiotic use at the time of membrane rupture diagnosis\n* Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis\n* Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis\n* Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis\n* Cervical dilation of ≥ 4 cm\n* Prolapse of fetal parts beyond the level of the internal cervical os\n* Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation'}, 'identificationModule': {'nctId': 'NCT05345457', 'briefTitle': 'Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age', 'orgStudyIdInfo': {'id': 'STUDY20220251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotics', 'description': 'Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days). Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.', 'interventionNames': ['Drug: Azithromycin Pill', 'Drug: Amoxicillin Pill']}, {'type': 'NO_INTERVENTION', 'label': 'No antibiotics', 'description': 'Patients randomized into the control (i.e., no antibiotics arm) will be managed according to standard of care practices for previable PPROM desiring of expectant management.'}], 'interventions': [{'name': 'Azithromycin Pill', 'type': 'DRUG', 'description': 'Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days).', 'armGroupLabels': ['Antibiotics']}, {'name': 'Amoxicillin Pill', 'type': 'DRUG', 'description': 'Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.', 'armGroupLabels': ['Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Felicia LeMoine, MD', 'role': 'CONTACT', 'email': 'felicia.lemoine@uhhosptials.org', 'phone': '(216) 983-6606'}], 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Felicia LeMoine, MD', 'role': 'CONTACT', 'email': 'felicia.lemoine@uhhospitals.org', 'phone': '(216) 983-6606'}], 'facility': 'MetroHealth', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44111', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Felicia LeMoine, MD', 'role': 'CONTACT', 'email': 'felicia.lemoine@uhhospitals.org', 'phone': '(216) 983-6606'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'centralContacts': [{'name': 'Felicia LeMoine, MD', 'role': 'CONTACT', 'email': 'felicia.lemoine@uhhospitals.org', 'phone': '(216) 983-6606'}, {'name': 'David Hackney, MD', 'role': 'CONTACT', 'email': 'david.hackney@uhhospitals.org', 'phone': '(216) 844-3787'}], 'overallOfficials': [{'name': 'David Hackney, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}, {'name': 'Justin Lappen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Brian Mercer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MetroHealth Hospitals'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will become available upon publication of study results and remain available for 2 years upon study completion.', 'ipdSharing': 'YES', 'description': 'Once data collection and primary analysis has been completed. A de-identified data set will be provided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'MetroHealth Medical Center', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Director, Maternal-Fetal Medicine', 'investigatorFullName': 'David Hackney MD, MS', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}