Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 6:17 PM
Study NCT ID:
NCT02145767
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2014-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2014-05-20', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Miscarriage', 'timeFrame': 'From 6-8 weeks of pregnancy until miscarriage', 'description': 'Occurrence of a miscarriage (\\<20 weeks)'}, {'measure': 'Preterm birth', 'timeFrame': 'From 6-8 weeks of pregnancy until delivery', 'description': 'Occurrence of preterm birth (\\<37 weeks)'}], 'secondaryOutcomes': [{'measure': 'Maternal outcomes', 'timeFrame': 'From 6-8 weeks of pregnancy until 6 weeks post delivery', 'description': 'Antenatal admissions, treatment of preterm labor etc.'}, {'measure': 'Neonatal outcomes', 'timeFrame': '2 days to 6 weeks post delivery', 'description': 'Malformations, growth restriction, prematurity associated morbidity, etc.'}, {'measure': 'Healthcare outcomes', 'timeFrame': 'From 6-8 weeks of pregnancy until 6 weeks post delivery', 'description': 'Hospital costs, etc'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Miscarriage', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Miscarriages and preterm births are common and serious events affecting women, families, and healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key role during pregnancy, has been proposed as a possible medication to be used in pregnancy to prevent miscarriage and preterm birth among women who have bleeding in their first trimester of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The purpose of our study is to evaluate the effect of progesterone for the prevention of miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a clinical trial in which 850 women will be randomized to receive either progesterone supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of their pregnancy will be compared.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Live intrauterine singleton pregnancy of \\<14 weeks by crown-rump length on ultrasound with documented fetal cardiac activity\n* Presence of a perigestational (subchorionic) hemorrhage on ultrasound\n\nExclusion Criteria:\n\n* Contraindication to Progesterone\n* Any indication for progesterone'}, 'identificationModule': {'nctId': 'NCT02145767', 'briefTitle': 'Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sir Mortimer B. Davis - Jewish General Hospital'}, 'officialTitle': 'Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial', 'orgStudyIdInfo': {'id': 'PRMT15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progesterone', 'description': 'Progesterone 200mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy.', 'interventionNames': ['Drug: Progesterone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Similar appearing suppository containing vehicle alone administered vaginally at bedtime until 34 completed weeks of pregnancy.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'armGroupLabels': ['Progesterone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2H 5Z8', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Karma Medical Clinic', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North York General Hospital'}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'MUHC Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Fleurimont', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Haim Abenhaim, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Mortimer B. Davis - Jewish General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Obstetrician & Gynecologist, Maternal Fetal Medicine Specialist, Director of Perinatal Research', 'investigatorFullName': 'Haim Abenhaim', 'investigatorAffiliation': 'Sir Mortimer B. Davis - Jewish General Hospital'}}}}