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RecruitingNCT06185894SPARTACUSUpdated Jun 4, 2024

Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery

An interventional study of Uterovesical tourniquet before uterine devascularization steps and Conventional conservative surgery in Placenta Accreta, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
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Study summary

Background: An optimal international standard for PAS surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in PAS management.

Objective: To assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum.

Patients and Methods: 40 pregnant women who underwent conservative management of placenta accrete at Kasr El-Aini hospital (Obstetrics and gynecology department - Faculty of medicine - Cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: Study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.Control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.

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Conditions studied

  • Placenta Accreta

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03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 67 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant females with previous CS deliveries (at least 1).
  • Patients with ultrasound criteria of placenta accerta spectrum.
  • Patients desiring fertility (uterine conservation).
  • Patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimester ultrasound scan.

Exclusion criteria

Exclusion Criteria:

  • Maternal age above 40 years.
  • Chronic medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
  • Patients presented with severe antepartum hemorrhage (unstable vital signs).
  • Patients requested radical management (caesarean hysterectomy).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Placebo comparator
    conservation without the use of a tourniquet

    surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet

    Procedure: Conventional conservative surgery

  • Active comparator
    conservation with the use of a tourniquet

    surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction

    Procedure: Uterovesical tourniquet before uterine devascularization steps

Interventions

  • ProcedureUterovesical tourniquet before uterine devascularization steps

    Insertion of a Foley catheter tourniquet through broad ligament apertures \& tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum

    Also known as: Uterine Pringles maneuver

  • ProcedureConventional conservative surgery

    Conventional conservative surgery

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What researchers measure

Primary outcomes

  1. Intraoperative quantified blood loss

    Quantified blood loss estimate with the tourniquet

    Time frame: during operation

Secondary outcomes

  1. amount of blood and blood product transfusion

    amount of blood and blood product transfusion

    Time frame: during operation and 48 hours post operative

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2024, 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
NCT06185894
Lead sponsor
Cairo University
Responsible party
Abdalla Mousa (Lecturer of obgyn Cairo university, Cairo University) — Principal investigator
First posted
Dec 29, 2023
Start date
Oct 1, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jun 4, 2024

Oversight

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

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