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临床试验/NCT02409602
NCT02409602已完成不适用

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

Near East University, Turkey1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Pulsatile index (PI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

结局指标

主要结局

Pulsatile index (PI)

时间窗: 6 months

Peak diastolic velocity (PDV)

时间窗: 6 months

Resistive index (RI)

时间窗: 6 months

Peak systolic velocity (PSV)

时间窗: 6 months

End diastolic velocity (EDV)

时间窗: 6 Months

Systolic/diastolic (S/D) ratio

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Near East University, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Baris KAYA

Assistant Professor, MD

Near East University, Turkey

研究点 (1)

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