Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575023
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Placenta accreta spectrum PAS represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium 1-2 Over the last 40 years caesarean delivery rates around the world have risen from less than 10 to over 30 and almost simultaneously a 10-fold increase in the incidence of PAS 3 PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality 4
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally There is also wide variation globally on the management of PAS disorders with some centres opting for a radical approach whereas others have proposed a range of conservative approaches 5
The conservative approaches include one-step conservative surgery leaving the placenta in situ the Triple-P procedure and transverse B-Lynch suture 1 Several techniques have been described for controlling massive bleeding associated with placenta previa caesarean sections including uterine packing with gauze balloon tamponades the B-Lynch sutureinsertion of parallel vertical compression sutures a square suturing technique and embolization or ligation of the uterine and internal iliac arteries but there is awide variation in the success rate of these maneuvers Over-sewing of the bleeding site is the most common procedure used for PPH management but in many cases the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally There is also wide variation globally on the management of PAS disorders with some centres opting for a radical approach whereas others have proposed a range of conservative approaches 5
The conservative approaches include one-step conservative surgery leaving the placenta in situ the Triple-P procedure and transverse B-Lynch suture 1 Several techniques have been described for controlling massive bleeding associated with placenta previa caesarean sections including uterine packing with gauze balloon tamponades the B-Lynch sutureinsertion of parallel vertical compression sutures a square suturing technique and embolization or ligation of the uterine and internal iliac arteries but there is awide variation in the success rate of these maneuvers Over-sewing of the bleeding site is the most common procedure used for PPH management but in many cases the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None