NCT02385747

Brief Summary

100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional curettage followed by histopathological examination and immunohistochemical analysis for estrogen and progesterone receptors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

March 3, 2015

Last Update Submit

March 18, 2017

Conditions

Vaginal Bleeding

Keywords

perimenopausal bleedingpostmenopausal bleedinghysteroscopySteroid receptors

Outcome Measures

Primary Outcomes (1)

  • detection of endometrial lesion

    2 days after curretage

Study Arms (1)

women with anbormal bleeding

EXPERIMENTAL

women with perimenopausal and postmenopausal bleeding who will be evaluated with transvaginal ultrasound, saline sonohysterography,hystroscopy and endometrial currettage

Procedure: hystroscopy

Interventions

hystroscopyPROCEDURE

Detailed hysteroscopic examination under general anesthesia Once the cavity entered, a panoramic view of the uterine cavity then systematic; first the fundus, then anterior, posterior and lateral walls of the uterus consecutively, ending by visualization of the uterine -tubal junctions, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity was observed and recorded. If there is any intrauterine pathology detected; the shape, size and site were estimated.

women with anbormal bleeding

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women older than 45 years with Abnormal uterine bleeding for more than 3 months duration

You may not qualify if:

  • history of hormonal treatment or hormonal contraception within the last 6 months. Women who had used IUD or those had hysteroscopy or fractional curettage done within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

EG(1)