Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases
1 other identifier
interventional
222
0 countries
N/A
Brief Summary
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 28, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
August 28, 2024
August 1, 2024
2 years
August 19, 2024
August 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
amount of intraopertive blood loss.
compare of amount of blood loss between two methods by adding collected blood in suction apparatus in milliliters to amount of biood in the soaked towels
2 years
Secondary Outcomes (4)
ICU admission
2 years
Re exploration
2 years
drop of HB level postoperative
2 years
blood transfusion
2 years
Study Arms (2)
tamponade of lower uterine segmentin managment of placenta accreta spectrum cases
ACTIVE COMPARATORusage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases
partial myometrial resection of lower uterine segment in management of placenta accreta spectrum
ACTIVE COMPARATORpartial resection of lower uterine segment myometrium
Interventions
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum
tamponade vs partial myomertial resection of lower uterine segment in managment of placenta accreta spectrum cases
Eligibility Criteria
You may qualify if:
- Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .
- Gestational age starting from 28 weeks onwards. 3- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy) 4- Elective or emergent Caesarean deliveries
You may not qualify if:
- A pre-existing decision of performing intrapartum hysterectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.
PMID: 23869630RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
August 19, 2024
First Posted
August 28, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
August 30, 2027
Last Updated
August 28, 2024
Record last verified: 2024-08