- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07706062
Surgical Management of Placenta Accreta Spectrum Disorders Using Total Lower Segmentectomy With Cervico-Corporeal Anastomosis and Adjunctive Mechanical Towel Compression
Surgical Management of Placenta Accreta Spectrum Disorders Using Total Lower Segmentectomy With Cervico-Corporeal Anastomosis and Adjunctive Mechanical Towel Compression: A Case Series
Study Overview
Status
Conditions
Detailed Description
Placenta accreta spectrum (PAS) disorders, characterized by abnormal trophoblastic invasion into the myometrium, have seen a global rise in incidence primarily driven by increasing cesarean delivery rates. Massive obstetric hemorrhage remains the leading cause of maternal morbidity and mortality in these cases.
While cesarean hysterectomy is the traditional gold standard for severe PAS, uteruspreserving procedures are increasingly preferred by patients desiring future fertility. Total lower uterine segmentectomy with cervico-corporeal anastomosis (TLS-CCA) is a recognized conservative technique that involves excising the invaded lower segment and reconstructing the uterus. Despite removing the primary placental implantation site, diffuse bleeding from the highly vascularized remaining myometrial bed, dissected bladder flap, and pelvic collateral vessels often persists. While traditional compression sutures or specialized devices are utilized for hemostasis, they can be costly or technically challenging in distorted anatomies. This study introduces a novel, simple, and cost-effective approach: the use of tightly rolled sterile surgical towelsapplied as direct mechanical compression against the lower uterine segment and bladder bed during dissection and reconstruction.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Maternal age 18-45 years
- Singleton pregnancy
- Antenatal diagnosis of PAS (ultrasound ± MRI)
- Planned elective cesarean delivery
- Candidate for uterine preservation via TLS-CCA
- Provided written informed consent
Exclusion Criteria:
- Hemodynamic instability necessitating emergency hysterectomy
- Placental invasion into adjacent pelvic organs requiring exenteration
- Pre-existing severe coagulation disorders
- Multiple gestation or major fetal anomalies
- Patient refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated intraoperative blood loss
Time Frame: at operation
|
Estimated intraoperative blood loss by (mL)
|
at operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood transfusion requirements
Time Frame: intraoperative
|
Blood transfusion requirements (units of packed RBCs and FFP)
|
intraoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nourhan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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