Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03907735
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin Receptor Expression in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D004420', 'term': 'Dystocia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'Blood Uterine biopsy tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxytocin receptor expression', 'timeFrame': '30 minutes', 'description': 'Measure of oxytocin receptor expression. Perform quantitative RT-PCR on mRNA extracted from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).'}], 'secondaryOutcomes': [{'measure': 'Function of myometrial oxytocin receptor', 'timeFrame': '30 minutes', 'description': 'Assessment of the function of the myometrial oxytocin receptor. Measure intracellular calcium in cultured myometrial cells after activating the receptor with oxytocin from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-abortion hemorrhage', 'Obstetric hemorrhage', 'Preterm labor', 'Abnormal labor', 'Oxytocin', 'Oxytocin receptor'], 'conditions': ['Post-Abortion', 'Hemorrhage, Obstetric']}, 'descriptionModule': {'briefSummary': 'This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.', 'detailedDescription': 'In this descriptive study, we will obtain myometrial tissue samples by core needle biopsy under ultrasound guidance in anesthetized women immediately following surgical abortion and from controls, all of whom are undergoing a separate planned obstetric/gynecologic surgery. Tissue studies will be performed on these biopsy samples to examine oxytocin receptor expression and function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "This is a study of reproductive age women over 18 years of age being performed at Oregon Health \\& Science University (OHSU) in Portland, OR. It will include subjects who present for pre-operative appointments in our outpatient Center for Women's Health Family Planning Clinic and OHSU Labor and Delivery.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women age 18-50\n* Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)\n* Undergoing another planned surgical procedure with anesthesia (suction D\\&C, D\\&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)\n* Able to give informed consent in English or Spanish\n\nExclusion Criteria:\n\nTo optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.\n\nIncreased risk of hemorrhage:\n\n* Anemia (Hgb \\< 9)\n* Anticoagulation, bleeding disorder, or coagulopathy\n* Multiple gestation\n* Infection or sepsis\n\nFor ultrasound-guided procedures:\n\n* Obese, BMI ≥ 40\n* History of ≥2 cesarean sections\n* Large fibroids or uterine anomalies obstructing view\n* Other poor visualization\n* Thin myometrium \\< 1cm'}, 'identificationModule': {'nctId': 'NCT03907735', 'briefTitle': 'Oxytocin Receptor Expression in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Oxytocin Receptor Expression in Pregnancy: When Does it Turn on', 'orgStudyIdInfo': {'id': 'OHSU IRB 19417'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2nd trimester', 'description': 'Second trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained primarily after second trimester surgical abortions or Dilation and Evacuation (D\\&E) procedures as well as after rare gravid hysterectomies or after late second trimester cesarean deliveries.', 'interventionNames': ['Other: Myometrial tissue sample collection']}, {'label': 'Non-pregnant', 'description': 'Myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in non-pregnant women undergoing gynecologic surgery under anesthesia for laparoscopic tubal ligation.', 'interventionNames': ['Other: Myometrial tissue sample collection']}, {'label': '1st trimester', 'description': 'First trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained after first trimester surgical abortions or suction dilation and curettage (D\\&C).', 'interventionNames': ['Other: Myometrial tissue sample collection']}, {'label': 'After term pregnancy (3rd trimester)', 'description': 'Third trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained at the time of cesarean delivery.', 'interventionNames': ['Other: Myometrial tissue sample collection']}], 'interventions': [{'name': 'Myometrial tissue sample collection', 'type': 'OTHER', 'description': 'Myometrial tissue samples by core needle biopsy under ultrasound guidance', 'armGroupLabels': ['1st trimester', '2nd trimester', 'After term pregnancy (3rd trimester)', 'Non-pregnant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Jessica Reid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Jessica Reid', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}