Influence of BIIAL Following PPH on Dorsal Clitoral Artery Blood Flow and FSFI

Postpartum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409602
• Other study ID #: CLITDOP-001
• Status: Completed
• Phase: N/A
• First received: April 1, 2015
• Last updated: March 20, 2016
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Near East University, Turkey
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 18-35 year-old women who underwent bilateral internal iliac artery ligation (BIIAL) due to postpartum hemorrhage

• Age-matched healthy puerperal women

Exclusion Criteria:

• Known Diabetes Melitus or cardiovascular disease

• Known affection disorder before or during pregnancy

• B-lynch procedure, ligation of uterine or ovarian artery, hysterectomy and salphingooophorectomy following postpartum hemorrhage

• Known functional sexual disorder before pregnancy

• Postoperative endometritis or other puerperal infections

• Postoperative thromboembolic incidence

• Cessation of breastfeeding in puerperal period

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bilateral Iliac Artery Ligation
• Hemorrhage
• Postpartum Hemorrhage

Intervention

Other:
• Doppler ultrasonographic examination
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.

Locations

Country	Name	City	State
Turkey	Near East University, Obstetrics and Gynecology	Mersin	Trnc

Sponsors (1)

Lead Sponsor	Collaborator
Near East University, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak systolic velocity (PSV)		6 months	No
Primary	Peak diastolic velocity (PDV)		6 months	No
Primary	Resistive index (RI)		6 months	No
Primary	End diastolic velocity (EDV)		6 Months	No
Primary	Pulsatile index (PI)		6 months	No
Primary	Systolic/diastolic (S/D) ratio		6 months	No