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

Assiut University

Status: Not yet enrolling

Conditions: Placenta Accreta

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06575023

management of placenta accreta

Details and patient eligibility

About

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 .

Full 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(

Enrollment: 222 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

tamponade of lower uterine segmentin managment of placenta accreta spectrum cases

Active Comparator group

Description:

usage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases

Treatment:

Procedure: Tamponade of lower uterine segment in management of placenta accreta spectrum cases

partial myometrial resection of lower uterine segment in management of placenta accreta spectrum

Active Comparator group

Description:

partial resection of lower uterine segment myometrium

Treatment:

Procedure: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases