Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-06 @ 10:31 AM
Study NCT ID:
NCT02409602
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2015-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of BIIAL Following PPH on Dorsal Clitoral Artery Blood Flow and FSFI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], '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'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-20', 'studyFirstSubmitDate': '2015-04-01', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak systolic velocity (PSV)', 'timeFrame': '6 months'}, {'measure': 'Peak diastolic velocity (PDV)', 'timeFrame': '6 months'}, {'measure': 'Resistive index (RI)', 'timeFrame': '6 months'}, {'measure': 'End diastolic velocity (EDV)', 'timeFrame': '6 Months'}, {'measure': 'Pulsatile index (PI)', 'timeFrame': '6 months'}, {'measure': 'Systolic/diastolic (S/D) ratio', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ultrasonography, Doppler, Color', 'Postpartum hemorrhage', 'Bilateral iliac artery ligation', 'Dorsal clitoral artery'], 'conditions': ['Bilateral Iliac Artery Ligation', 'Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '29102811', 'type': 'DERIVED', 'citation': 'Kaya B, Usluogullari B, Yurttutan N, Sahan MH, Guralp O, Malik E. Does ligation of internal iliac artery for postpartum hemorrhage affect clitoral artery blood flow and postpartum sexual functions? Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:124-128. doi: 10.1016/j.ejogrb.2017.10.029. Epub 2017 Oct 31.'}]}, 'descriptionModule': {'briefSummary': 'Dorsal clitoral artery Doppler examinations in women with bilateral internal iliac artery ligation due to postpartum hemorrhage (study group) and age-matched healthy puerperal women were performed regularly in the postoperative period, in order to evaluate possible effects of BIIAL on clitoral blood flow.', 'detailedDescription': 'Women who underwent bilateral internal iliac artery ligation due to postpartum hemorrhage in Gaziantep Cengiz Gokcek Maternity Hospital, Gaziantep Turkey and Near East University, Department of Obstetrics and Gynecology, Mersin, Turkey comprise the study group. The control group consists of age-matched healthy women who delivered in last 2 months.\n\nDorsal clitoral artery Doppler examinations will be performed in both case and control groups regularly in the postoperative period in 3rd and 6th months, in order to evaluate the possible effects of BIIAL on clitoral blood flow. Ultrasound is performed using a Mindray DC-7 Ultrasound System (China) equipped with linear 7.5 MHz probe. Each woman was scanned in the gynecological position. The translabial probe is placed on the clitoris sagittally and transversely without applying any pressure force. After identifying the clitoral artery using colour flow mapping, the Doppler probe is positioned over the vessel and at least three sequential Doppler wave forms are obtained. The following parameters are analysed: peak systolic velocity (PSV), end diastolic velocity (EDV), resistive index (RI), pulsatile index (PI) and systolic/diastolic (S/D) ratio. The measurements are performed by the same radiologist.\n\nFinally a Female Sexual Fantasy Questionnaire (FSFQ) is performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18-35 year old women with postpartum hemorrhage who did and did not undergo bilateral internal iliac artery ligation (BIIAL)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-35 year-old women who underwent bilateral internal iliac artery ligation (BIIAL) due to postpartum hemorrhage\n* Age-matched healthy puerperal women\n\nExclusion Criteria:\n\n* Known Diabetes Melitus or cardiovascular disease\n* Known affection disorder before or during pregnancy\n* B-lynch procedure, ligation of uterine or ovarian artery, hysterectomy and salphingooophorectomy following postpartum hemorrhage\n* Known functional sexual disorder before pregnancy\n* Postoperative endometritis or other puerperal infections\n* Postoperative thromboembolic incidence\n* Cessation of breastfeeding in puerperal period'}, 'identificationModule': {'nctId': 'NCT02409602', 'briefTitle': 'Influence of BIIAL Following PPH on Dorsal Clitoral Artery Blood Flow and FSFI', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'Comparison of the Dorsal Clitoral Artery Doppler Examination Results and the Female Sexual Function Index in Women With Postpartum Hemorrhage Who Underwent Bilateral Internal Iliac Artery Ligation and Age-matched Healthy Postpartum Women', 'orgStudyIdInfo': {'id': 'CLITDOP-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with BIIAL', 'description': 'Women who underwent bilateral internal iliac artery ligation due to postpartum hemorrhage within last 2 months', 'interventionNames': ['Other: Doppler ultrasonographic examination']}, {'label': 'Healthy puerperal women', 'description': 'Age-matched healthy puerperal women who delivered within last 2 months', 'interventionNames': ['Other: Doppler ultrasonographic examination']}], 'interventions': [{'name': 'Doppler ultrasonographic examination', 'type': 'OTHER', 'description': 'Dorsal clitoral artery Doppler ultrasonographic examinations will be performed regularly in 3rd and 6th months after delivery, in order to evaluate the possible effects of BIIAL on clitoral blood flow.', 'armGroupLabels': ['Healthy puerperal women', 'Women with BIIAL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10', 'city': 'Mersin', 'state': 'Trnc', 'country': 'Turkey (Türkiye)', 'facility': 'Near East University, Obstetrics and Gynecology', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, MD', 'investigatorFullName': 'Baris KAYA', 'investigatorAffiliation': 'Near East University, Turkey'}}}}