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

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage; Bilateral Iliac Artery Ligation
• Intervention / Treatment: Other: Doppler ultrasonographic examination

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Turkey
  • Trnc
    • Mersin, Trnc, Turkey, 10
      • Near East University, Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with BIIAL; Women who underwent bilateral internal iliac artery ligation due to postpartum hemorrhage within last 2 months	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.
Healthy puerperal women; Age-matched healthy puerperal women who delivered within last 2 months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peak systolic velocity (PSV)	6 months
Peak diastolic velocity (PDV)	6 months
Resistive index (RI)	6 months
End diastolic velocity (EDV)	6 Months
Pulsatile index (PI)	6 months
Systolic/diastolic (S/D) ratio	6 months

Collaborators and Investigators

• Sponsor: Near East University, Turkey

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 6, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Postpartum hemorrhage; Ultrasonography, Doppler, Color; Bilateral iliac artery ligation; Dorsal clitoral artery
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: CLITDOP-001