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NCT Number: NCT06575023

Tamponade vs Partial Myometrial Resection 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 .

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Key information

About this study

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(

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

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

Procedure

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

Primary outcomes

  1. amount of intraopertive blood loss.

    Time frame: 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 outcomes

  1. ICU admission

    Time frame: 2 years

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

  2. Re exploration

    Time frame: 2 years

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

  3. drop of HB level postoperative

    Time frame: 2 years

    result of substitution of HB level postoperative from preoperative in gmldl

  4. blood transfusion

    Time frame: 2 years

    amount of transfused blood units

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Nabil, master degree

CONTACT

[email protected]

[email protected]

Esraa Badran, assistant professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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