Actively Recruiting
Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With Placenta Accreta Spectrum Disorders Undergoing Cesarean Hysterectomy
Led by Cairo University · Updated on 2024-07-10
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of oxytocin in reducing blood loss during surgery for patients with Placenta Accreta Spectrum (PAS) disorders who are scheduled for cesarean hysterectomy. This study aims to compare the impact of uterotonics, specifically oxytocin, against a placebo to understand their role in managing blood loss in these patients. Participants will be randomly assigned to one of two groups: one receiving an intravenous bolus of 10 units of oxytocin immediately with the uterine incision, and the other receiving an intravenous bolus of normal saline as a placebo at the same time. The study uses a triple-blind design to ensure unbiased results and includes patients aged 20 to 40 years undergoing cesarean hysterectomy due to PAS. During the study, researchers will monitor the amount of blood lost during the operation and measure the operative time. The study involves patients with specific ultrasound markers and preoperative hemoglobin levels over 10 gm/dl. Participants will be observed closely during surgery to assess these outcomes, and safety and effectiveness will be evaluated throughout the process.
CONDITIONS
Brief Title
Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnancy of singleton living fetus
- Previous one or more cesarean sections
- Gestational age greater than 32 weeks
- Presence of specific ultrasound markers: loss of clear retroplacental translucency, myometrial thinning, abnormal lacunae, irregular bladder wall, utero-vesical hypervascularity
- Preoperative hemoglobin more than 10 gm/dl
- Diagnosed with PAS and scheduled for cesarean hysterectomy
You will not qualify if you...
- Presence of maternal medical disorders such as coagulation defects or cardiac diseases
- Known or reported hypersensitivity to the medications used in the study
- Cases with spontaneous placental separation at laparotomy
- Patients undergoing conservative management of PAS
- Cases requiring emergency termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During the operation
Participants receive either uterotonics or a placebo intravenously immediately with the uterine incision during cesarean hysterectomy.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
A
Abdalla Mousa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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