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Not yet recruiting NCT06575023

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

No phase Interventional Placenta Accreta

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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 cases.
Who it may be relevant to
Registry conditions: Placenta Accreta. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Procedure Tamponade 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
  • Procedure partial 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

Primary outcome measures

  • amount of intraopertive blood loss. [Time frame: 2 years]
Secondary outcome measures (4)
  • ICU admission [Time frame: 2 years]
  • Re exploration [Time frame: 2 years]
  • drop of HB level postoperative [Time frame: 2 years]
  • blood transfusion [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 23869630

Identifiers

NCT: NCT06575023 · management of placenta accreta

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗