Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT03689166
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2018-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded RCT'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Definition and design. Prospective, double-blind randomised study.\n\nPopulation Pregnant women admitted for TPL between weeks 24.0 and 34.6 of gestation at the participating centre.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2018-02-11', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preterm birth rate <37 weeks', 'timeFrame': 'From 24 to 37 weeks', 'description': 'To evaluate the percentage of preterm birth in each group (in days of gestation)'}], 'secondaryOutcomes': [{'measure': 'Preterm birth rate <34 weeks', 'timeFrame': 'From 24 to 34 weeks', 'description': 'To evaluate the percentage of preterm birth in each group (in days of gestation)'}, {'measure': 'Preterm birth rate <32 weeks', 'timeFrame': 'From 24 to 32 weeks', 'description': 'To evaluate the percentage of preterm birth in each group (in days of gestation)'}, {'measure': 'Preterm birth rate <30 weeks', 'timeFrame': 'From 24 to 30 weeks', 'description': 'To evaluate the percentage of preterm birth in each group (in days of gestation)'}, {'measure': 'Preterm birth rate <28 weeks', 'timeFrame': 'From 24 to 38 weeks', 'description': 'To evaluate the percentage of preterm birth in each group (in days of gestation)'}, {'measure': 'Intergroup neonatal morbidity', 'timeFrame': 'First year of life of newborns', 'description': 'To assess neonatal morbidity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Preterm birth', 'Threatened preterm labour'], 'conditions': ['Preterm Birth']}, 'referencesModule': {'references': [{'pmid': '40426968', 'type': 'DERIVED', 'citation': 'Del Barco E, Molano LG, Vargas M, Miserachs M, Puerto L, Garrido-Gimenez C, Soler Z, Munoz B, Pratcorona L, Rimbaut S, Vidal M, Dalmau M, Casellas A, Carreras E, Manichanh C, Goya M. The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial). Biomedicines. 2025 May 8;13(5):1141. doi: 10.3390/biomedicines13051141.'}]}, 'descriptionModule': {'briefSummary': 'Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (\\> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.', 'detailedDescription': 'Hypothesis\n\n* Pregnant women with threatened preterm labour (TPL) will present vaginal microbiome different from those without TPL.\n* Treatment with probiotics will modify the vaginal microbioma of pregnant women with TPL.\n* The PB rate before 37 weeks in pregnant women with TPL who have received probiotics since their diagnosis will be reduced by at least 30%.\n\nGoals\n\n* To correlate the use of probiotics of pregnant women with TPL with the PB rate before 37 weeks.\n* To ascertain the PB rate before 28, 30, 32 and 34 weeks in both groups.\n* To assess neonatal morbidity between both groups.\n\nMethods\n\nProspective, randomised, longitudinal, prospective, double-blind study.\n\nRelevance\n\nThis study will determine whether the use of probiotics in pregnant women with TPL is associated with a lower risk of PB before 37 weeks. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. It will also facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Threatened preterm labour: regular clinical and cardiotography-registered uterine dynamics, and cervical modifications (cervical shortening ≤ 25 mm between 24 and 29 weeks, and ≤ 15 mm between 30 and 34 weeks) according to our care protocol.\n* Single gestation.\n* Echographically-normal foetal morphology.\n* Minimum age 18 years.\n* Ability to understand informed consent.\n* Signed informed consent.\n\nExclusion criteria\n\n* Multiple gestations.\n* Pregnant women with diagnosis of chorioamnionitis.\n* Cervical dilation.'}, 'identificationModule': {'nctId': 'NCT03689166', 'acronym': 'PROPEV', 'briefTitle': 'Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Maternal-Infantil Vall d´Hebron Hospital'}, 'officialTitle': 'Effect of Probiotics on the Preterm Delivery Rate (< 37 Weeks) in Pregnant Women at High Risk for Preterm Birth (Pregnant Women With Threatened Preterm Labour): PROPEV TRIAL Protocol', 'orgStudyIdInfo': {'id': 'PR(AMI)236/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics group', 'description': 'Probiotic drug', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'This group will receive placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Reduce preterm birth with this dietary supplement', 'armGroupLabels': ['Probiotics group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Herbron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study will allow us to determine whether the use of probiotics in pregnant women with TPL is associated with an increased risk of PB. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. Similarly, it will facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maternal-Infantil Vall d´Hebron Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}