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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04944355
Collaborator
(none)
110
1
6
18.3

Study Details

Study Description

Brief Summary

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.

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 Design

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective Study
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. • 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]

    • 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asyut university women health hospital Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Beshoy Kedes Roshdy Said, Urinary tract injuries during caesarean section for morbidly adherent placenta: prospective and retrospective study, Assiut University
ClinicalTrials.gov Identifier:
NCT04944355
Other Study ID Numbers:
  • Urinary tract injuries at MAP
First Posted:
Jun 29, 2021
Last Update Posted:
Jun 29, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2021