NCT04162782

Brief Summary

Iatrogenic urinary tract injuries are more common during obstetric and gynaecological procedures averaging 2.6 per 1000 surgeries . The objective of the study is to estimate the incidence of iatrogenic urinary tract injuries and risk factors during obstetric and gynaecological operations. Embryologically, the urinary system and genital system have a common origin, so anatomically they are so close that predisposes to iatrogenic trauma to it during obstetric and gynaecological operations. The bladder and distal ureters are the most commonly involved organs. The bladder is a retroperitoneal structure, its trigone rests over the anterior vaginal fornix and the base rests on lower uterine segment and cervix.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Status
unknown

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

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 12, 2019

Last Update Submit

November 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations.

    frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations.

    one month

Interventions

surgeries for gynecologic and obstetric diseases

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women undergo obstetric or gynecological surgery complicated by urinary tract injury .

You may qualify if:

  • Women that undergo obstetric or gynecological surgery complicated by urinary tract injury
  • Aged 15 years or older
  • Elective surgeries
  • Good performance status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tarney CM. Bladder Injury During Cesarean Delivery. Curr Womens Health Rev. 2013 May;9(2):70-76. doi: 10.2174/157340480902140102151729.

    PMID: 24876830BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

November 14, 2019

Record last verified: 2019-11