NCT04944355

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 29, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

June 22, 2021

Last Update Submit

June 22, 2021

Conditions

Outcome Measures

Primary Outcomes (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)

    • 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

Interventions

diagnosis of morbid adherent placenta and incidence of urinary tract injuries during surgery

Also known as: doppler

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asyut university women health hospital

Asyut, Egypt

Location

Related Publications (13)

  • Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.

    PMID: 28599899BACKGROUND
  • Chantraine F, Braun T, Gonser M, Henrich W, Tutschek B. Prenatal diagnosis of abnormally invasive placenta reduces maternal peripartum hemorrhage and morbidity. Acta Obstet Gynecol Scand. 2013 Apr;92(4):439-44. doi: 10.1111/aogs.12081.

    PMID: 23331024BACKGROUND
  • Jauniaux E, Chantraine F, Silver RM, Langhoff-Roos J; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Epidemiology. Int J Gynaecol Obstet. 2018 Mar;140(3):265-273. doi: 10.1002/ijgo.12407. No abstract available.

    PMID: 29405321BACKGROUND
  • Fitzpatrick KE, Sellers S, Spark P, Kurinczuk JJ, Brocklehurst P, Knight M. The management and outcomes of placenta accreta, increta, and percreta in the UK: a population-based descriptive study. BJOG. 2014 Jan;121(1):62-70; discussion 70-1. doi: 10.1111/1471-0528.12405. Epub 2013 Aug 7.

    PMID: 23924326BACKGROUND
  • Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.

    PMID: 29669225BACKGROUND
  • Baldwin HJ, Patterson JA, Nippita TA, Torvaldsen S, Ibiebele I, Simpson JM, Ford JB. Antecedents of Abnormally Invasive Placenta in Primiparous Women: Risk Associated With Gynecologic Procedures. Obstet Gynecol. 2018 Feb;131(2):227-233. doi: 10.1097/AOG.0000000000002434.

    PMID: 29324602BACKGROUND
  • Jauniaux E, Bhide A. Prenatal ultrasound diagnosis and outcome of placenta previa accreta after cesarean delivery: a systematic review and meta-analysis. Am J Obstet Gynecol. 2017 Jul;217(1):27-36. doi: 10.1016/j.ajog.2017.02.050. Epub 2017 Mar 6.

    PMID: 28268196BACKGROUND
  • Familiari A, Liberati M, Lim P, Pagani G, Cali G, Buca D, Manzoli L, Flacco ME, Scambia G, D'antonio F. Diagnostic accuracy of magnetic resonance imaging in detecting the severity of abnormal invasive placenta: a systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2018 May;97(5):507-520. doi: 10.1111/aogs.13258. Epub 2017 Dec 13.

    PMID: 29136274BACKGROUND
  • Morel O, Collins SL, Uzan-Augui J, Masselli G, Duan J, Chabot-Lecoanet AC, Braun T, Langhoff-Roos J, Soyer P, Chantraine F; International Society for Abnormally Invasive Placenta (IS-AIP). A proposal for standardized magnetic resonance imaging (MRI) descriptors of abnormally invasive placenta (AIP) - From the International Society for AIP. Diagn Interv Imaging. 2019 Jun;100(6):319-325. doi: 10.1016/j.diii.2019.02.004. Epub 2019 Mar 8.

    PMID: 30853416BACKGROUND
  • Korniluk A, Kosinski P, Wielgos M. Intraoperative damage to the urinary bladder during cesarean section - literature review. Ginekol Pol. 2017;88(3):161-165. doi: 10.5603/GP.a2017.0031. No abstract available.

    PMID: 28397207BACKGROUND
  • Salman L, Aharony S, Shmueli A, Wiznitzer A, Chen R, Gabbay-Benziv R. Urinary bladder injury during cesarean delivery: Maternal outcome from a contemporary large case series. Eur J Obstet Gynecol Reprod Biol. 2017 Jun;213:26-30. doi: 10.1016/j.ejogrb.2017.04.007. Epub 2017 Apr 5.

    PMID: 28411456BACKGROUND
  • Alanwar A, Al-Sayed HM, Ibrahim AM, Elkotb AM, Abdelshafy A, Abdelhadi R, Abbas AM, Abdelmenam HS, Fares T, Nossair W, Abdallah AA, Sabaa H, Nawara M. Urinary tract injuries during cesarean section in patients with morbid placental adherence: retrospective cohort study. J Matern Fetal Neonatal Med. 2019 May;32(9):1461-1467. doi: 10.1080/14767058.2017.1408069. Epub 2017 Dec 3.

    PMID: 29157027BACKGROUND
  • Ozcan HC, Balat O, Ugur MG, Sucu S, Tepe NB, Kazaz TG. Use of Bladder Filling to Prevent Urinary System Complications in the Management of Placenta Percreta: a Randomized Prospective Study. Geburtshilfe Frauenheilkd. 2018 Feb;78(2):173-178. doi: 10.1055/s-0044-100039. Epub 2018 Feb 19.

    PMID: 29479114BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urinary tract injuries during caesarean section for morbidly adherent placenta: prospective and retrospective study

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 29, 2021

Study Start

June 1, 2021

Primary Completion

October 30, 2021

Study Completion

December 1, 2021

Last Updated

June 29, 2021

Record last verified: 2021-04

Locations