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Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases

Not Applicable
Not yet recruiting
Conditions
Placenta Accreta
Interventions
Procedure: Tamponade of lower uterine segment in management of placenta accreta spectrum cases
Procedure: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases
Registration Number
NCT06575023
Lead Sponsor
Assiut University
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 suture,insertion 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(

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
Female
Target Recruitment
222
Inclusion Criteria
  • 1-Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .

    2 - 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

Exclusion Criteria
  • A pre-existing decision of performing intrapartum hysterectomy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
tamponade of lower uterine segmentin managment of placenta accreta spectrum casesTamponade of lower uterine segment in management of placenta accreta spectrum casesusage 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 spectrumpartial myometrial resection of lower uterine segment in management of placenta accreta spectrum casespartial resection of lower uterine segment myometrium
Primary Outcome Measures
NameTimeMethod
amount of intraopertive blood loss.2 years

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

Secondary Outcome Measures
NameTimeMethod
blood transfusion2 years

amount of transfused blood units

drop of HB level postoperative2 years

result of substitution of HB level postoperative from preoperative in gmldl

ICU admission2 years

yes or no admission number of days if there is ICU admission cause of admission

Re exploration2 years

if there is exploration or no cause of re-exploration outcome of re-exploration

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