Clinical trial NCT02409602: Influence of BIIAL Following PPH on Dorsal Clitoral Artery Blood Flow and FSFI
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bilateral Iliac Artery Ligation
Postpartum Hemorrhage
Keywords: Ultrasonography, Doppler, Color
Postpartum hemorrhage
Bilateral iliac artery ligation
Dorsal clitoral artery
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-35 year old women with postpartum hemorrhage who did and did not undergo bilateral internal iliac artery ligation (BIIAL)

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Near East University, Obstetrics and Gynecology
state: Trnc
Study officials:
References:
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.