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

NCT ID: NCT02409602

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Bilateral Iliac Artery Ligation Postpartum Hemorrhage

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with BIIAL

Women who underwent bilateral internal iliac artery ligation due to postpartum hemorrhage within last 2 months

Doppler ultrasonographic examination

Intervention Type 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.

Healthy puerperal women

Age-matched healthy puerperal women who delivered within last 2 months

Doppler ultrasonographic examination

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Near East University, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Baris KAYA

Assistant Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Near East University, Obstetrics and Gynecology

Mersin, Trnc, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 29102811 (View on PubMed)

Other Identifiers

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CLITDOP-001

Identifier Type: -

Identifier Source: org_study_id

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