Office Hysteroscopy and 3D Power Doppler Vaginal Ultrasound in Assessment of Postmenopausal Bleeding

NCT02488798 | Completed

• 1 other identifier: 62014
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

100 patients with postmenopausal bleeding were assessed with 2D vaginal ultrasound and 3D power Doppler ultrasound using the international endometrial tumor analysis group and office hysteroscopy with taking samples for histopathological analysis.

Conditions

Postmenopausal Bleeding

Outcome Measures

Primary Outcomes (1)

• Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding

  Efficacy of 3D power Doppler ultrasound with the IETA group criteria in diagnosing the cause of postmenopausal bleeding

  1 week

Study Arms (1)

postmenopausal bleeding group

100 women with postmenopausal bleeding undergoing 2D greyscale vaginal ultrasound and 3D Endometrial power Doppler and the features were classified using six different vascular patterns described by IETA group including the following patterns; single dominant vessel without branching, with branching, multiple vessels with focal origin, with multifocal origin at the myometrium-endometrium junction, scattered vessels or circular flow (Kucur et al., 2013 ). All patients then had Office hysteroscopy carried out in the outpatient clinic using vaginoscopic approach (Cooper et al., 2010). With endometrial samples from lesions or from the cavity for histopathological analysis.

Procedure: 2D grey scale vaginal ultrasound; Procedure: 3D power Doppler vaginal ultrasound; Procedure: Office hysteroscopy

Interventions

2D grey scale vaginal ultrasound PROCEDURE

To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).

postmenopausal bleeding group

3D power Doppler vaginal ultrasound PROCEDURE

To assess the endometrium using the IETA group criteria.

postmenopausal bleeding group

Office hysteroscopy PROCEDURE

using the vaginoscopic approach to assess the uterine cavity and take sample.

postmenopausal bleeding group

Eligibility Criteria

• Age: 47 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with postmenopausal bleeding

You may qualify if:

• patients complaining of postmenopausal bleeding. Postmenopausal bleeding was defined as vaginal bleeding that occurred after at least 12 months of amenorrhea.

Sponsors & Collaborators

• Cairo University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sample from the uterine endometrium for histopathological analysis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 2, 2015

Record last verified: 2015-06