Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-26 @ 12:05 PM
Study NCT ID:
NCT01698957
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2012-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Uterine Artery Doppler Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine Artery Doppler', 'timeFrame': 'at time of routine ultrasound', 'description': 'The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnant women', 'Uterine Artery Doppler Velocimetry'], 'conditions': ['Maternal-Fetal Exchange']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to detect if adding resistance to maternal blood flow from the arm will help increase the blood flow through the uterine arteries to the placenta and the baby.', 'detailedDescription': "In the setting of uteroplacental insufficiency, there is little that can be done to increase blood flow through the uterus and placenta. Historically, women with growth restricted fetuses or oligohydramnios have been placed on bed rest. Unfortunately, this treatment modality has met with only limited success. Cardiologists have long recognized the simple act of making a fist or otherwise occluding blood flow through a limb dramatically increases a person's peripheral vascular resistance. If maternal peripheral resistance can be increased, perhaps the increased differential between the maternal peripheral vascular resistance and that of the uteroplacental unit will increase flow through the uterus and placenta."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women greater than or equal to 18 weeks gestation and 18 years old eligible for an ultrasound without fetal or uterine anomalies', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women greater than or equal to 18 years old\n* Able to speak and read English\n* Have a singleton pregnancy greater than or equal to 18 weeks gestation\n\nExclusion Criteria:\n\n* Multiple gestation\n* Less than 18 weeks gestation\n* Uterine anomalies\n* Fetal anomalies\n* Preeclampsia\n* Hypertension\n* Inability to have BP cuff on left arm'}, 'identificationModule': {'nctId': 'NCT01698957', 'briefTitle': 'Maternal Uterine Artery Doppler Study', 'organization': {'class': 'OTHER', 'fullName': 'Pediatrix'}, 'officialTitle': 'A Simple Technique to Modify Maternal Uterine Artery Perfusion.', 'orgStudyIdInfo': {'id': 'UA Doppler 2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UA Doppler Velocimetry', 'description': 'Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.', 'interventionNames': ['Other: Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.']}], 'interventions': [{'name': 'Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.', 'type': 'OTHER', 'description': 'bilateral Uterine artery Doppler readings pre- and during blood pressure measurement', 'armGroupLabels': ['UA Doppler Velocimetry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Perinatal Associates', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Perinatal Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Thomas H Strong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Obstetrix Medical Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obstetrix Medical Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}