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Completed

NCT Number: NCT02409602

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Near East University, Obstetrics and Gynecology

Mersin, Trnc, 10, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doppler ultrasonographic examination

Other

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.

Primary outcomes

  1. Peak systolic velocity (PSV)

    Time frame: 6 months

  2. Peak diastolic velocity (PDV)

    Time frame: 6 months

  3. Resistive index (RI)

    Time frame: 6 months

  4. End diastolic velocity (EDV)

    Time frame: 6 Months

  5. Pulsatile index (PI)

    Time frame: 6 months

  6. Systolic/diastolic (S/D) ratio

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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