Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-12 @ 8:18 AM
Study NCT ID:
NCT02853656
Status:
TERMINATED
Last Update Posted:
2024-01-12
First Post:
2016-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time to Delivery of 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-07-29', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnosis of heightened risk of imminent delivery', 'timeFrame': '7 days', 'description': 'preterm birth at 7 days'}, {'measure': 'diagnosis of heightened risk of imminent delivery', 'timeFrame': '14 days', 'description': 'preterm birth at 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['preterm birth', 'gestation'], 'conditions': ['Pre Term Birth']}, 'descriptionModule': {'briefSummary': 'Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.\n\nWhen mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.\n\nThere are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).\n\nThe purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.', 'detailedDescription': 'Preterm birth (babies being born before 34 weeks pregnancy) occurs in approximately 11% of pregnancies; preterm birth can lead to complications for the baby.\n\nWhen mothers are identified as being at risk of going into preterm birth (giving birth within the next 14 days) there are several treatments available that may help reduce the likelihood of complications for the baby. These treatments usually need to be started within 24 hours so it is very important that diagnosing preterm labour in not only fast but accurate.\n\nThere are several methods commonly used within hospitals for diagnosing mothers who may be at risk of going into preterm labour. The two most common ones are foetal fibronectin (fFN) and phosphorylated insulin-like growth factor binding protein 1 (phIGFBP-1).\n\nThe purpose of this study is to compare the two tests to see which is more accurate at predicting preterm birth.\n\nThis is a prospective comparative study of fFN (control) and PhIGFBP-1 test (comparator) for women with singleton pregnancies between 22-34 weeks gestation presenting with self-reported signs, symptoms or complaints suggestive of preterm labour.\n\nBoth tests will be done on every participant - the tests will be sequenced so that every 5 participants the fFN test is undertaken first and then the next cohort of 5 will have the PhIGFBP-1 swab taken first. This is to remove any potential biases surrounding which test was undertaken first. Data collection (case report forms (CRFs)) will clearly document which test was performed 1st and 2nd.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with singleton pregnancy between 22-34 weeks gestation with signs and symptoms of pre term birth', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* aged ≥ 18 years\n* confirmed pregnancy\n* gestational age between 22 and 34 weeks\n* self-reported signs, symptoms or complaints suggestive of preterm labour;\n\n * abdominal pain\n * contractions\n * pelvic pressure\n\nExclusion criteria\n\n* unable to provide written informed consent\n* multiple pregnancy\n* participating in an interventional clinical trial\n* a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)\n* contraindicated to either fFN or PhIGFBP-1; e.g.\n\n * vaginal bleeding\n * cervical dilation ≥3cm dilated\n * evidence of rupture of membranes\n * had intercourse in last 24 hours\n * cervical cerclage in situ\n * placenta praevia'}, 'identificationModule': {'nctId': 'NCT02853656', 'briefTitle': 'Time to Delivery of Preterm Birth', 'organization': {'class': 'OTHER', 'fullName': 'Mid and South Essex NHS Foundation Trust'}, 'officialTitle': 'Time to Delivery of Preterm Birth', 'orgStudyIdInfo': {'id': 'B868'}, 'secondaryIdInfos': [{'id': '194502', 'type': 'OTHER', 'domain': 'IRAS ID'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Basildon Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}], 'overallOfficials': [{'name': 'Amaju Ikomi, MBBS FRCOG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Basildon and Thurrock University Hospitals NHS FT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mid and South Essex NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}