Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT00646802
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, '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': 265}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-26', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of deliveries before week 34 of gestation', 'timeFrame': 'week 34 of gestation'}], 'secondaryOutcomes': [{'measure': 'Median time from randomization to delivery', 'timeFrame': 'delivery'}, {'measure': 'Ultrasound cervical length', 'timeFrame': 'week +5'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Threatened Premature Labor']}, 'descriptionModule': {'briefSummary': 'Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women aged between 18 - 45 years\n* Gestational age between 24.0 and before 33.6 gestational weeks\n* Singleton pregnancy\n* Patients admitted because of preterm labor who have been successfully treated of any tocolytic drugs (β-mimetics drugs, nifedipine, atosiban)\n* Ultrasound cervical length at discharge \\< 25 mm\n* Signed patient consent form (CI)\n\nExclusion Criteria:\n\n* Known or suspected infection, premature rupture of membranes or any other pathological gravid maternal or fetal condition coexisting at hospital admission (Pre-eclampsia, RCIU) which may induce iatrogenic labor.\n* Present or previous liver disease, present or previous cholestasis gravidarum, abnormal hepatic blood tests.\n* With known allergy to progesterone or peanuts (excipient).\n* Grade 2 (or upper) renal or liver laboratory abnormalities\n* Treated from dependent-hormone malignant cancer (i.e., breast carcinoma...)\n* With Diabetes mellitus or insulinized gestational diabetes\n* Treated with heparin\n* Drug abuse\n* Inadequate treatment compliance'}, 'identificationModule': {'nctId': 'NCT00646802', 'acronym': 'PROMISE', 'briefTitle': 'Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'PROMISE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Progesterone 200 mg', 'interventionNames': ['Drug: Progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'description': '1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '08028', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant joan de Déu de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitària Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'zip': '08227', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Terrassa. CST', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '11009', 'city': 'Cadiz', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '35016', 'city': 'Las Palmas de Gran Canaria', 'state': 'Gran Canaria', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Insular-Materno Infantil', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital U Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41009', 'city': 'Seville', 'state': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen de la Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '50009', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Clinico U. Lozano Blesa', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Montse Palacio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Montse Palacio', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}