Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-05 @ 5:12 PM
Study NCT ID:
NCT02199756
Status:
UNKNOWN
Last Update Posted:
2018-11-02
First Post:
2014-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanovectors to Prevent Placental Passage of Tocolytic Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Uterine biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2014-07-23', 'studyFirstSubmitQcDate': '2014-07-23', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine contractions', 'timeFrame': '3 hours', 'description': 'Uterine biopsies obtained from subjects will be placed in a specimen chamber that measures uterine contractility. Mean contractile intensity will be determined before and after exposure to oxytocin, indomethacin, liposomes and liposome indomethacin.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine contractions', 'Indomethacin', 'Nanovectors'], 'conditions': ['Preterm Labor']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.', 'detailedDescription': 'This is a prospective observational study.\n\nSubjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean section after delivery of the baby. Once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. This biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. Once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who will undergo elective cesarean section at term', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women undergoing elective cesarean section who are greater than 37 weeks\n\nExclusion Criteria:\n\n* Known infection'}, 'identificationModule': {'nctId': 'NCT02199756', 'briefTitle': 'Nanovectors to Prevent Placental Passage of Tocolytic Agents', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent', 'orgStudyIdInfo': {'id': 'HSC-MS-14-0370'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cesarean section', 'description': 'Women with cesarean section'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Hutchinson, M.S.', 'role': 'CONTACT', 'email': 'maria.keefer@uth.tmc.edu', 'phone': '713-500-6421'}, {'name': 'Jerrie S Refuerzo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Hermann Hospital Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Jerrie S Refuerzo, M.D.', 'role': 'CONTACT', 'email': 'jerrie.s.refuerzo@uth.tmc.edu', 'phone': '713-500-6416'}], 'overallOfficials': [{'name': 'Jerrie S Refuerzo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jerrie Refuerzo', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}