The Efficacy of a Temporary Sub-Placental Uterine Tourniquet in Minimizing Intraoperative Blood Loss in Management of Placenta Accreta Spectrum Disorder by a Retrograde Cesarean Hysterectomy (Bladder Last)

NCT05936645 | Unknown

• 1 other identifier: MD-429-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will study the role of a temporary tourniquet around the uterus to reduce blood loss in management of patients with abnormally implanted placenta who will undergo removal of the uterus.

Conditions

Placenta Accreta

Keywords

Placenta Accreta Spectrum; Tourniquet; Cesarean Hysterectomy; Bladder Last; Blood loss

Outcome Measures

Primary Outcomes (1)

• The estimated total blood loss.

  ml

  24 hours

Secondary Outcomes (6)

• Operative time

  From the start of the procedure till the end.

• Need for blood transfusion

  before, during and immediately after the procedure

• Internal organ injury (Bladder, intestine, ureter)

  during the operative procedure

• Inadvertent injury to the pelvic vessels (eg. Injury to the ovarian vessels while inserting the tourniquet)

  during the operative procedure

• ICU admission

  immediately after the procedure

Study Arms (2)

Tourniquet Group

EXPERIMENTAL

A temporary sub-placental uterine tourniquet will be temporarily applied before fetal extraction.

Procedure: A temporary sub-placental Uterine Tourniquet in management of Placenta Accreta Spectrum disorder by a retrograde cesarean hysterectomy (Bladder Last)

Non-Tourniquet Group

EXPERIMENTAL

No tourniquet will be used in this arm.

Procedure: Retrograde cesarean hysterectomy (Bladder Last) for management of Placenta Accreta Spectrum disorder

Interventions

A temporary sub-placental Uterine Tourniquet in management of Placenta Accreta Spectrum disorder by a retrograde cesarean hysterectomy (Bladder Last) PROCEDURE

Comparing the use of a temporary sub-placental uterine tourniquet versus no tourniquet in reducing blood loss in patients with Placenta Accreta Spectrum disorder undergoing cesarean hysterectomy.

Tourniquet Group

Retrograde cesarean hysterectomy (Bladder Last) for management of Placenta Accreta Spectrum disorder PROCEDURE

Comparing the use of a temporary sub-placental uterine tourniquet versus no tourniquet in reducing blood loss in patients with Placenta Accreta Spectrum disorder undergoing cesarean hysterectomy.

Non-Tourniquet Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age: pregnancy completing 35 weeks or more.
• Previous one or more cesarean delivery.
• Current pregnancy complicated by Placenta Accreta Spectrum Disorder candidate for cesarean hysterectomy either total or partial Placenta Accreta. (i.e. Total: Most of the placenta is adherent to the myometrium with no plane of cleavage. Partial: 2-3 cotyledons are only adherent to the myometrium with no plane of cleavage at these cotyledons)
• Elective termination of pregnancy.
• Preoperative Hemoglobin ≥ 10 g/dl

You may not qualify if:

• Patients who refuse to participate in the study.
• Women with history of a concomitant chronic or a pregnancy associated medical disorder eg. Gestational diabetes, hypertension, cardiac or renal disease.
• Presence of a concomitant uterine pathology (eg. Uterine fibroid)
• Premature rupture of membranes.
• Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative or as total/partial accreta and found to be focal accreta intraoperative.
• Cases requiring preoperative blood transfusion.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Research Ethics Committee, Faculty of Medicine, Cairo University

Cairo, Egypt

RECRUITING

Related Publications (9)

• Alves ALL, Silva LBD, Costa FDS, Rezende GC. Management of placenta accreta spectrum. Rev Bras Ginecol Obstet. 2021 Sep;43(9):713-723. doi: 10.1055/s-0041-1736371. Epub 2021 Oct 20. No abstract available.

  PMID: 34670307 BACKGROUND

• Altal OF, Qudsieh S, Ben-Sadon A, Hatamleh A, Bataineh A, Halalsheh O, Amarin Z. Cervical tourniquet during cesarean section to reduce bleeding in morbidly adherent placenta: a pilot study. Future Sci OA. 2022 Mar 8;8(4):FSO789. doi: 10.2144/fsoa-2021-0087. eCollection 2022 Apr.

  PMID: 35369280 BACKGROUND

• Bartels HC, Postle JD, Downey P, Brennan DJ. Placenta Accreta Spectrum: A Review of Pathology, Molecular Biology, and Biomarkers. Dis Markers. 2018 Jul 3;2018:1507674. doi: 10.1155/2018/1507674. eCollection 2018.

  PMID: 30057649 BACKGROUND

• Donovan BM, Shainker SA. Placenta Accreta Spectrum. Neoreviews. 2021 Nov;22(11):e722-e733. doi: 10.1542/neo.22-11-e722.

  PMID: 34725137 BACKGROUND

• Huang J, Zhang X, Liu L, Duan S, Pei C, Zhao Y, Liu R, Wang W, Jian Y, Liu Y, Liu H, Wu X, Zhang W. Placenta Accreta Spectrum Outcomes Using Tourniquet and Forceps for Vascular Control. Front Med (Lausanne). 2021 Oct 18;8:557678. doi: 10.3389/fmed.2021.557678. eCollection 2021.

  PMID: 34733857 BACKGROUND

• Hussein AM, Elbarmelgy RA, Elbarmelgy RM, Thabet MM, Jauniaux E. Prospective evaluation of impact of post-Cesarean section uterine scarring in perinatal diagnosis of placenta accreta spectrum disorder. Ultrasound Obstet Gynecol. 2022 Apr;59(4):474-482. doi: 10.1002/uog.23732. Epub 2022 Mar 8.

  PMID: 34225385 BACKGROUND

• Jauniaux E, Hussein AM, Elbarmelgy RM, Elbarmelgy RA, Burton GJ. Failure of placental detachment in accreta placentation is associated with excessive fibrinoid deposition at the utero-placental interface. Am J Obstet Gynecol. 2022 Feb;226(2):243.e1-243.e10. doi: 10.1016/j.ajog.2021.08.026. Epub 2021 Aug 28.

  PMID: 34461077 BACKGROUND

• Morlando M, Collins S. Placenta Accreta Spectrum Disorders: Challenges, Risks, and Management Strategies. Int J Womens Health. 2020 Nov 10;12:1033-1045. doi: 10.2147/IJWH.S224191. eCollection 2020.

  PMID: 33204176 BACKGROUND

• Stafford I, Dildy GA, Clark SL, Belfort MA. Visually estimated and calculated blood loss in vaginal and cesarean delivery. Am J Obstet Gynecol. 2008 Nov;199(5):519.e1-7. doi: 10.1016/j.ajog.2008.04.049. Epub 2008 Jul 17.

  PMID: 18639209 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta; Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Moutaz M Elsherbini, MD

  Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt

  STUDY DIRECTOR

Central Study Contacts

Ahmed Eltawil, MSc

CONTACT

+201100009781; ahmed.eltawil512@gmail.com

Abdalla Mousa, MD

CONTACT

+201277664430; dr_abdallamousa@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 10, 2023
• Study Start: August 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication and no end date
• Access Criteria: anyone who wishes to access the data

Locations

EG (1)