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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06575023
Enrollment
222
Registered
2024-08-28
Start date
2024-09-01
Completion date
2027-08-30
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

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(

Interventions

PROCEDURETamponade of lower uterine segment in management of placenta accreta spectrum cases

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

PROCEDUREpartial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases

tamponade vs partial myomertial resection of lower uterine segment in managment of placenta accreta spectrum cases

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
amount of intraopertive blood loss.2 yearscompare 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

MeasureTime frameDescription
ICU admission2 yearsyes or no admission number of days if there is ICU admission cause of admission
Re exploration2 yearsif there is exploration or no cause of re-exploration outcome of re-exploration
drop of HB level postoperative2 yearsresult of substitution of HB level postoperative from preoperative in gmldl
blood transfusion2 yearsamount of transfused blood units

Contacts

Primary ContactAbdelrahman Nabil, master degree
nabilabdelrahman722@gmail.comnabilabdelrahman722@gmail.com
Backup ContactEsraa Badran, assistant professor
esrabdran@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026