Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective Study

June 22, 2021 updated by: Beshoy Kedes Roshdy Said, Assiut University
M1- evaluates the cases of lower urinary tract injuries during caesarean section with or without hysterectomy in cases with morbid placental adherence in the period between years 2018 and 2021. This study was carried out in assiut university women health hospital M 2- Clarification of the risk factors and outcome of urinary tract injuries.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Placenta accreta spectrum disorder (PAS), also called abnormally invasive placenta (AIP), describes a clinical situation where the placenta does not detach spontaneously after delivery and cannot be forcibly removed without causing massive and potentially life-threatening bleeding(1-2) The incidence of PAS is rising worldwide(3) PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality.(4) PAS may occur after any kind of procedure that causes damage to the endometrium, including curettage, manual removal of the placenta, uterine-artery embolization, or myomectomy(5-6) a full thickness surgical scar is associated with both the absence of endometrial re-epithelialization and vascular remodelling around the scar area, and this may lead to abnormally invasive placentation (increta/percreta).(7) Ultrasound is the first-line imaging tool for the screening and diagnosis of PAS. However, it is now well-established that magnetic resonance imaging (MRI) has a role in the diagnosis of PAS, with high sensitivity and specificity(8-9) Urinary bladder injury is one of the operative morbidities of cesarean section. It occurs in 0.08% - 0.94% of cesarean sections(10) Repeated cesarean section and type of morbidly adherent placenta (MAP) are considered the major risk factors for urinary tract injuries during cesarean delivery(11) Urinary bladder injury complicates about 11.7% of cesarean sections in women with placenta accreta spectrum (PAS)(12) The presence of tough adhesions between the bladder and the lower uterine segment carries the risk of urinary bladder injury. Trial of separation of the bladder in such circumstances may result in bladder injury. Filling of the bladder will delineate the contour of the bladder and clarify the proper plane of dissection (13)

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Asyut university women health hospital
        • Contact:

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

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

  1. This cross-sectional study will be conducted in Assiut University Hospital by analysis of records of cesarian section with or without hysterectomy in patient with morbid adherent placenta will be conducted and the cases complicated by urinary tract injuries from october2018 to october 2021.
  2. The occurrence of urinary tract injuries will be estimated and the records of those with injuries will be analysed prospectively from October 2018 to october 2021and retrospectively in terms of site and characteristics of injury, difference in management by different specialists, requirement of urologist for management, type of suturing, need for cystoscopy and catheter in situ placement.

Study design:

This study is a prospective and retrospective study

Description

Inclusion Criteria:

  • All cases in the 3rd trimester admitted to Asyut university women health hospital and diagnosed antenatally as having morbidly adherent placenta

    • Confirmed diagnosis of MAP.
    • Peri partum hysterectomy for MAP.
    • Complicated CS without hysterectomy
    • Maternal age between 18 and 45 yrs
    • No other medical diseases

Exclusion Criteria:

  • associated other uterine pathology
  • Refusal of the patient
  • Emergency CS before confirming MAP diagnosis.
  • Urinary tract injuries due to other causes than MAP
  • Presence of major medical disorders e.g. DM, PE, Cardiac lesion, Coagulopathy, liver diseases or kidney diseases
  • Postpartum depression.

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Evaluate the incidence of different types of lower urinary tract injuries during caesarean section with or without hysterectomy in cases with morbid placental adherence(bladder-ureteric-bladder and ureteric injuries)
Time Frame: BASELINE
• Evaluate the incidence of different types of lower urinary tract injuries during caesarean section with or without hysterectomy in cases with morbid placental adherence(bladder-ureteric-bladder and ureteric injuries)
BASELINE

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Urinary tract injuries at MAP

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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