A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study

NCT06957184 | Not Yet Recruiting

• 1 other identifier: bladder disection in PAS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018). caesarean hysterectomy is considered the gold standard for the treatment of placenta accreta. Also this radical approach is associated with high rates of severe maternal morbidity as hemorrhage and insult to surrounding organs during surgery (Hoffman et al., 2010). Surgeons should be able to dissect the bladder safely and confidently through minimally invasive techniques, to avoid surgical injury, it is important to use anatomic landmarks, minimize the use of cauterization (Farhat and Casale, 2018). All centers are encouraged to develop guidelines to manage the potential urologic complications of these cases tailored to their resources (Taneja and Shah, 2017). This study aims to evaluate the timing of bladder dissection in caesarean section in patient with placenta accreta spectrum.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• o Blood loss

  assessed by number of soaked towels and suction reservoir)

  1 year

Study Arms (2)

group A

ACTIVE COMPARATOR

40 patients will have bladder dissection at the start of caesarean section for patient with morbidly adherent placenta

Procedure: bladder dissection in placenta accreta spectrum

group b

ACTIVE COMPARATOR

40 patients will have bladder dissection after closing uterine incision and just before clamping uterine artery in case of caesarean hysterectomy

Procedure: bladder dissection in placenta accreta spectrum

Interventions

bladder dissection in placenta accreta spectrum PROCEDURE

All caesarean sections will be performed by a surgeon who has experience in performing caesarean hysterectomy in both groups. * Scrubbing the abdomen as usual. * Subumblical midline skin incision versus Pfannenstiel incision will be chosen according to site of the placenta and previous surgeries. * In group A careful bladder dissection will be done before uterine incision with ensuring hemostasis, uterine incision will be done above the placenta, after delivering the baby awaiting for placental separation if not proceeding for caesarean hysterectomy. * In group B uterine incision will be done above the placenta and after delivering the baby awaiting for placental separation if not proceeding to caesarean hysterectomy and dissecting bladder just before clamping uterine artery.

group A; group b

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with BMI at or under 35kg/m2
• Women with history of at least previous two caesarean section
• Gestational age more than 32 weeks with viable fetus.
• Women with any degree of placenta previa.
• Women with placenta falling in the PAS.
• Willing and able to provide informed consent.

You may not qualify if:

• o History of urinary bladder injury.
• History of urinary or renal disorders
• Women with coagulation disorders or on anticoagulation therapy.
• Patients who are hemodynamically unstable before skin incision

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (4)

• Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.

  PMID: 19191778 BACKGROUND

• Hoffman MS, Karlnoski RA, Mangar D, Whiteman VE, Zweibel BR, Lockhart JL, Camporesi EM. Morbidity associated with nonemergent hysterectomy for placenta accreta. Am J Obstet Gynecol. 2010 Jun;202(6):628.e1-5. doi: 10.1016/j.ajog.2010.03.021.

  PMID: 20510963 BACKGROUND

• 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: 28599899 BACKGROUND

• Marshall NE, Fu R, Guise JM. Impact of multiple cesarean deliveries on maternal morbidity: a systematic review. Am J Obstet Gynecol. 2011 Sep;205(3):262.e1-8. doi: 10.1016/j.ajog.2011.06.035. Epub 2011 Jun 15.

  PMID: 22071057 BACKGROUND

Related Links

• pubmed

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• khaled saed, professor

  direcror

  STUDY DIRECTOR

Central Study Contacts

salma M hussain, assistan lecturer

CONTACT

00201145895970; salmaa_mohd@hotmail.com

Hatem Elsayed, lecturer

CONTACT

00201009525878

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share