Placenta AccretaSPARTACUSNCT06185894
Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery
A study testing Uterovesical tourniquet before uterine devascularization steps and Conventional conservative surgery in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Uterovesical tourniquet before uterine devascularization steps and Conventional conservative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 30 Jun 2024
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Abdalla Mousa, +201277664430, Dr_abdallamousa@yahoo.com
About this study
Official title: Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study
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.
- Conditions
- Placenta Accreta
- Being tested
- Uterovesical tourniquet before uterine devascularization steps, Conventional conservative surgery
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterovesical tourniquet before uterine devascularization stepsProcedure or surgery
Also called Uterine Pringles maneuver
Insertion of a Foley catheter tourniquet through broad ligament apertures \& tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum
Conventional conservative surgeryProcedure or surgery
Conventional conservative surgery
| Study group | Role | What they receive |
|---|---|---|
| conservation without the use of a tourniquet | Placebo comparator | surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet Receives: Procedure: Conventional conservative surgery |
| conservation with the use of a tourniquet | Active comparator | surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction Receives: Procedure: Uterovesical tourniquet before uterine devascularization steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative quantified blood loss
Quantified blood loss estimate with the tourniquet
Measured: during operation
Secondary outcomes (1)
amount of blood and blood product transfusion
amount of blood and blood product transfusion
Measured: during operation and 48 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185894
- Sponsor's protocol ID
- Ms-105-2023
- Acronym
- SPARTACUS
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mousa A, Gaafar HM, Abdullah M, Elsherbini MM, Abdel-Rasheed M, Rida D, Saysaneh A, Collins SL, Abdelbar A. Uterovesical tourniquet for conservative management of placenta accreta spectrum: a prospective cohort study in a low-resource setting. BMC Pregnancy Childbirth. 2025 Dec 12;26(1):57. doi: 10.1186/s12884-025-08381-7.
PubMed 41387818
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study
- ClinicalTrials.gov ID
- NCT06185894
- Acronym / sponsor ID
- SPARTACUS / Ms-105-2023
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservation without the use of a tourniquet | Placebo comparator | Procedure: Conventional conservative surgerysurgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet |
| conservation with the use of a tourniquet | Active comparator | Procedure: Uterovesical tourniquet before uterine devascularization stepssurgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterovesical tourniquet before uterine devascularization stepsAlso: Uterine Pringles maneuverInsertion of a Foley catheter tourniquet through broad ligament apertures \& tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum | Procedure or surgery | conservation with the use of a tourniquet |
| Conventional conservative surgeryConventional conservative surgery | Procedure or surgery | conservation without the use of a tourniquet |
Primary outcome
Intraoperative quantified blood loss
Time frame: during operation
Quantified blood loss estimate with the tourniquet
1 secondary outcome
amount of blood and blood product transfusion
Time frame: during operation and 48 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 41387818Mousa A, Gaafar HM, Abdullah M, Elsherbini MM, Abdel-Rasheed M, Rida D, Saysaneh A, Collins SL, Abdelbar A. Uterovesical tourniquet for conservative management of placenta accreta spectrum: a prospective cohort study in a low-resource setting. BMC Pregnancy Childbirth. 2025 Dec 12;26(1):57. doi: 10.1186/s12884-025-08381-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterovesical tourniquet before uterine devascularization steps and Conventional conservative surgery in people with Placenta Accreta, run by Cairo 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 4 inclusion and 4 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 4 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative quantified blood loss (time frame: during operation). 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 NCT06185894, which also lists 1 linked publication.
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 4 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.