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Status unknownNCT05510076Updated Aug 22, 2022

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

An observational study in Placenta Accreta Spectrum, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to female participants aged Up to 51 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
Up to 51 Years
Sex
Female
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Study 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.

Read the detailed 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.

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Conditions studied

  • Placenta Accreta Spectrum

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03

In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 79 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Sohag University is the lead sponsor of 1,182 studies on the registry; 611 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 51 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

community sample, any suspected case of PAS disorders.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A

    in which full-thickness vertical compression suture combined with inflated intrauterine balloon are used to control bleeding

  • Group B

    in this group, a resective-reconstructive technique is used, which involves resecting the invasive accreta area followed by immediate uterine reconstruction and bladder reinforcement

  • Group C

    In this group, bilateral uterine artery ligations combined with cervical tamponade which is performed by elevating the cervix into the uterine cavity with Allis forceps, then suturing the anterior and/ or posterior cervical lip(s) into the anterior and/ or posterior uterine segment(s) depending on the site of bleeding with two or three simple interrupted stitches, with the patency of the cervical canal confirmed, followed by closure of the uterine incision

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What researchers measure

Primary outcomes

  1. successful intervention procedure

    Preservation of the uterus

    Time frame: 1 day

  2. 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

    Time frame: 6 weeks

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05510076
Lead sponsor
Sohag University
Responsible party
Abdallah Ahmed Refaat (mr., Sohag University) — Principal investigator
First posted
Aug 22, 2022
Start date
Aug 1, 2022
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Aug 22, 2022

Study contacts

AbdAllah Refaat
Contact
abdallah.refaat@med.sohag.edu.eg
+201141519467
AbdAllah Refaat
Contact
abdoscopy@gmail.com
+01555518179

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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