Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-02-21 @ 5:25 PM
Study NCT ID:
NCT02277132
Status:
TERMINATED
Last Update Posted:
2018-07-26
First Post:
2014-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'whyStopped': 'Results of interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2014-09-29', 'studyFirstSubmitQcDate': '2014-10-26', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fetal ultrasound and Doppler studies: estimated fetal weight, abdominal circumference and Doppler of umbilical artery', 'timeFrame': 'At contact moments with the patients, up to 20 weeks after randomization', 'description': 'Umbilical artery, middle cerebral artery, ductus venosus and aortic isthmus Doppler indices; fetal biometry; amniotic fluid index; deepest vertical amniotic fluid pocket.'}, {'measure': 'PlGF (Placental Growth Factor) point-of-care assessment', 'timeFrame': 'At baseline', 'description': 'If possible in designated clinic'}], 'primaryOutcomes': [{'measure': 'Intact neonatal survival until term age', 'timeFrame': 'Term age, up to 20 weeks after randomization'}], 'secondaryOutcomes': [{'measure': 'Fetal growth velocity assessed by ultrasound: abdominal circumference measurements (AC)', 'timeFrame': 'At contact moments with the patient, up to 20 weeks after randomization', 'description': 'Average daily increase in ultrasound-estimated AC'}, {'measure': 'Age-adequate performance on the two-year Bayley scales of infant development (BSID)-III (composite cognitive score and composite motor score)', 'timeFrame': '2 years corrected age, up to 2 years and three months after randomization'}, {'measure': 'Co-incidence and severity of the maternal syndrome of pre-eclampsia / HELLP-syndrome (Hemolysis Elevated Liver enzymes Low Platelets)', 'timeFrame': 'At contact moments with the patient, up to 20 weeks after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fetal growth restriction', 'Sildenafil'], 'conditions': ['Fetal Growth Restriction']}, 'referencesModule': {'references': [{'pmid': '32585017', 'type': 'DERIVED', 'citation': 'Pels A, Derks J, Elvan-Taspinar A, van Drongelen J, de Boer M, Duvekot H, van Laar J, van Eyck J, Al-Nasiry S, Sueters M, Post M, Onland W, van Wassenaer-Leemhuis A, Naaktgeboren C, Jakobsen JC, Gluud C, Duijnhoven RG, Lely T, Gordijn S, Ganzevoort W; Dutch STRIDER Trial Group. Maternal Sildenafil vs Placebo in Pregnant Women With Severe Early-Onset Fetal Growth Restriction: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e205323. doi: 10.1001/jamanetworkopen.2020.5323.'}, {'pmid': '30635020', 'type': 'DERIVED', 'citation': 'Pels A, Jakobsen JC, Ganzevoort W, Naaktgeboren CA, Onland W, van Wassenaer-Leemhuis AG, Gluud C. Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction. Trials. 2019 Jan 11;20(1):42. doi: 10.1186/s13063-018-3136-z.'}, {'pmid': '29282009', 'type': 'DERIVED', 'citation': 'Pels A, Kenny LC, Alfirevic Z, Baker PN, von Dadelszen P, Gluud C, Kariya CT, Mol BW, Papageorghiou AT, van Wassenaer-Leemhuis AG, Ganzevoort W, Groom KM; international STRIDER Consortium. STRIDER (Sildenafil TheRapy in dismal prognosis early onset fetal growth restriction): an international consortium of randomised placebo-controlled trials. BMC Pregnancy Childbirth. 2017 Dec 28;17(1):440. doi: 10.1186/s12884-017-1594-z.'}]}, 'descriptionModule': {'briefSummary': "Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. Placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. There is currently no therapy available with demonstrated effectiveness. Evidence suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes.\n\nObjective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival.\n\nStudy design: Multicenter nationwide randomized placebo-controlled clinical trial.\n\nStudy population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death.\n\nIntervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected medication-associated risks can't be excluded on beforehand."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria ((I OR II) AND III):\n\n* At 20+0-27+6 weeks: an ultrasound measurement of the fetal abdominal circumference (AC) \\<3rd percentile for gestational age or an ultrasound estimate of fetal weight (EFW) \\<5th percentile OR\n* At 28+0-29+6 weeks: an ultrasound estimate of fetal weight (EFW) \\<700 grams using Hadlock C formula AND\n* Likely placental origin defined by (a AND/OR b AND/OR c AND/OR d)\n\n * The presence of uterine artery notching\n * Abnormal flow velocity patterns of the umbilical artery or middle cerebral artery\n * Maternal hypertensive disorders\n * Low PlGF in point-of-care assessment\n\nExclusion Criteria:\n\n* Plan to terminate pregnancy for maternal or fetal indication within days\n* Known multiple pregnancy\n* Identified congenital anomalies or congenital infection\n* Maternal age at eligibility \\<18 years\n* Cocaine use\n* Current use of sildenafil\n* Current use of cyp3A5 inhibitors: amiodaron, azitromycine, ciclosporine, claritromycine, diltiazem, erytromycine, fluconazol, itraconazol, ketoconazol, verapamil, voriconazol.\n* Recent myocardial infarction or stroke'}, 'identificationModule': {'nctId': 'NCT02277132', 'acronym': 'STRIDER', 'briefTitle': 'The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)', 'orgStudyIdInfo': {'id': '80-83600-98-20081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sildenafil', 'description': 'Sildenafil 25 mg tablets three times daily orally from randomization until delivery', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets three times daily orally from randomization until delivery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': 'Sildenafil 25 mg three times daily orally from randomization until delivery', 'armGroupLabels': ['Sildenafil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets three times daily orally from randomization until delivery', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud Medisch Centrum Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '6202AZ', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht Universitair Medisch Centrum', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '5504 DB', 'city': 'Veldhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '1081HV', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Vrije Universiteit Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '8025 AB', 'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'zip': '2333ZA', 'city': 'Leiden', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '3015CE', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus Medisch Centrum Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '9713GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3584CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'J.W. Ganzevoort, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'K Bloemenkamp, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leiden University Medical Center'}, {'name': 'P von Dadelszen, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University of British Columbia'}, {'name': 'C de Groot, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'VU Medisch Centrum'}, {'name': 'M.W. de Laat, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'B.W. Mol, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'M. Porath, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Perinataal Centrum MMC Veldhoven'}, {'name': 'J.A.M. van der Post, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, {'name': 'A. van Wassenaer, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'J.W. Ganzevoort MD PhD', 'investigatorFullName': 'Wessel Ganzevoort', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}