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Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective StudyNCT04944355

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

An observational study of Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective Study, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
ultrasound
How many people
110 participants
Where
1 siteEgypt
Study dates
Jun 2021to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

beshoy kedes contact

01025244686

beshoyroshdy667@gmail.com

Ahmed Alaa El-Din contact

01006184921

AHMEDALAA11282@gmail.com

Egypt1 site

  • Asyut university women health hospital

    Asyut

    Ahmed Mohamed Alaa El-Din Mahmoud Youssef, 01006184921, AHMEDALAA11282@gmail.com

Other trials in Egypt

About this study

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.

Read the 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)

Being tested
ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasoundOther

    Also called doppler

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: BASELINE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study startJun 2021 (estimated)
  3. Primary completion30 Oct 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944355
Sponsor's protocol ID
Urinary tract injuries at MAP
Status last verified
Apr 2021
First submitted
22 Jun 2021
Last updated
29 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28599899

  • 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.

    PubMed 23331024

  • 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.

    PubMed 29405321

  • 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.

    PubMed 23924326

  • 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.

    PubMed 29669225

  • 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.

    PubMed 29324602

  • 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.

    PubMed 28268196

  • 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.

    PubMed 29136274

  • 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.

    PubMed 30853416

  • 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.

    PubMed 28397207

  • 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.

    PubMed 28411456

  • 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.

    PubMed 29157027

  • 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.

    PubMed 29479114

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective Study, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact beshoy kedes (01025244686, beshoyroshdy667@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944355, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.

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