Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital

Placenta Accreta Spectrum Clinical Trial

Official title:

Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510076
• Other study ID #: Soh-Med-22-08-03
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Sohag University
• Contact: AbdAllah Refaat
• Phone: +201141519467
• Email: abdallah.refaat[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate different intra-operative procedures to control bleeding in cases of PAS disorders aiming to determine the best procedure regarding maternal morbidity and mortality post-operatively, and to evaluate the long-term effects of conservative management of PAS disorders.

Description:

The term "placenta accreta spectrum" (PAS), formerly known as "morbidly adherent placenta" or "abnormally invasive placenta," refers to the aberrant trophoblast invasion of all or a portion of the placenta into the myometrium of the uterus. according to the depth of the villous invasion into the myometrium, the spectrum is assorted into three groups: placenta accreta (villi attach to the myometrium without invading it), placenta increta (villi infiltrate the myometrium), and placenta percreta (villi pierce through the uterine serosa and may infiltrate the surrounding tissues). The optimal strategy for managing PAS disorders remains debatable. Conservative management of PAS disorders includes all techniques aimed at preserving the uterus. Because intraoperative bleeding from PAS disorders is frequently massive and dramatic, causing severe maternal morbidity and mortality, it is essential to have a well-planned, effective, and rapid approach to this surgical challenge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 51 Years

Eligibility

Inclusion Criteria:

• Women with at least one previous caesarean section and suspected PAS disorders by imaging studies

Exclusion Criteria:

• Patients with intraoperative spontaneous placental separation.
• Patients with a preoperative diagnosis of placenta percreta who chose to have an elective hysterectomy.
• Any other associated uterine pathology requiring hysterectomy.
• Coagulation disorders.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful intervention procedure	Preservation of the uterus	1 day
Primary	maternal mortality and morbidity	ICU admission, need of re-exploration, drop of hemoglobin and hematocrit values, massive blood transfusion, bladder and/ or ureteric injury, coagulopathy, infection and hospital re-admission within 6 weeks	6 weeks