Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding (Niche)

April 25, 2017 updated by: Ahmed Elsayed Hassan Elbohoty, Ain Shams University
Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal sonography in women With Unexplained Abnormal Uterine Bleeding

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria :

  • Normal complete blood count apart from paramaters of anemia
  • Not using drugs affecting coagulation profile
  • Bleeding is not related to pregnancy
  • Not using intrauterine contraceptive devices or hormonal contraceptives
  • By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors
  • No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears

Exclusion Criteria:

  • Any patient not fulfilling the inclusion criteria
  • If the patient refused the technique ( office hysteroscopy )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Office hysteroscopy
Examinatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section
Device: Office Hysteroscope
Diagnosis of C.S niche in patients wit AUB by office hysteroscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of cisarean section niche
Time Frame: 1 year
Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

April 20, 2017

Study Registration Dates

First Submitted

April 22, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEldawa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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