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:
Near East University, Turkey
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Dorsal 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.
Finally a Female Sexual Fantasy Questionnaire (FSFQ) is performed.
Dorsal 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.
Finally a Female Sexual Fantasy Questionnaire (FSFQ) is performed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: