Uterovesical tourniquet for conservative management of placenta accreta spectrum: a prospective cohort study in a low-resource setting.
Abdalla Mousa, Hassan M Gaafar, Mohamed Abdullah...
https://pubmed.ncbi.nlm.nih.gov/41387818Actively Recruiting
Phase Not Applicable
Age: 20Years - 40Years
FEMALE
ID06185894
Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study
Led by Cairo University · Updated on 2024-06-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a uterine tourniquet during conservative surgery for placenta accreta spectrum, a serious pregnancy condition where the placenta attaches too deeply to the uterus. This study aims to compare outcomes between using a tourniquet and not using one to find a safer and more effective surgical method. The trial is conducted at Cairo University and involves pregnant women with this condition who wish to preserve fertility. Participants will be randomly assigned to one of two groups: one group will receive a uterovesical tourniquet applied before fetal delivery during surgery, while the other group will undergo conventional conservative surgery without the tourniquet. The tourniquet is inserted via a Foley catheter through the broad ligament and tightened just before the uterine incision. Both groups receive the Kasr El-Aini conservative management technique for placenta accreta spectrum. During the surgery and up to 48 hours afterward, researchers will measure the amount of blood loss and any blood transfusions needed to assess safety and efficacy. Participants will be monitored closely during the operation and postoperatively to collect these data. The study includes women aged 20 to 40 years with confirmed placenta accreta spectrum and previous cesarean deliveries, aiming to gather evidence to improve surgical care for this condition.
CONDITIONS
Brief Title
Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery
Who Can Participate
Age: 20Years - 40Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Pregnant females with at least one previous cesarean delivery
- Diagnosed with placenta accreta spectrum by ultrasound
- Desire to preserve fertility (uterine conservation)
- Gestational age of 34 weeks or more confirmed by last menstrual period or early ultrasound
You will not qualify if you...
- Maternal age above 40 years
- Chronic medical disorders such as heart, kidney, diabetes, or liver diseases
- Severe antepartum hemorrhage with unstable vital signs
- Patients requesting radical management like cesarean hysterectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo surgical conservation of placenta accreta spectrum cases either with or without the use of a uterovesical tourniquet before fetal extraction.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - 48 hours post-operative
Participants are monitored for blood loss and transfusion requirements during the operation and up to 48 hours after surgery.
Approximately 2 visits (in-person) during hospitalization
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here