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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Placenta Accreta
• Intervention / Treatment: 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

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(

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdelrahman Nabil, master degree; Phone Number: nabilabdelrahman722@gmail.com; Email: nabilabdelrahman722@gmail.com
• Study Contact Backup: Name: Esraa Badran, assistant professor; Email: esrabdran@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tamponade of lower uterine segmentin managment of placenta accreta spectrum cases; usage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases	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
Active Comparator: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum; partial resection of lower uterine segment myometrium	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of intraopertive blood loss.	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU admission	yes or no admission number of days if there is ICU admission cause of admission	2 years
Re exploration	if there is exploration or no cause of re-exploration outcome of re-exploration	2 years
drop of HB level postoperative	result of substitution of HB level postoperative from preoperative in gmldl	2 years
blood transfusion	amount of transfused blood units	2 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta
• Other Study ID Numbers: management of placenta accreta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No