Placenta Accreta Spectrum Disorders: A. Chohan Continuous Squeezing Suture (ACCSS)

NCT05070689 | Unknown

• 1 other identifier: SMDC/SMRC/209-21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta Accreta Spectrum (PAS) disorders are rising in incidence due to increased rate of repeat caesarean sections. Peripartum hysterectomy remains the only definitive treatment of massive postpartum haemorrhage related to this condition. Researchers have described conservative treatments in the form of pelvic devascularization under radiological control, myometrial resection with placenta in situ, and various suturing techniques some involving inversion of cervix. Variable success rates are described, but search continues for a simple, safe and effective treatment. The objective of this study is to assess the simplicity, safety and efficacy of A. Chohan Continuous Squeezing Suture (ACCSS) in the management of PAS.

Conditions

Placenta Accreta

Keywords

Peripartum Hystrectomy; Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Peripartum Hysterectomy

  Absolute number of peripartum hysterectomies within the study group

  24 hours

Secondary Outcomes (9)

• Application time of suture in minutes

  within 20 minutes

• Estimated blood loss

  First 24 hours

• Number of units of blood transfusions

  First 24 hours

• Intensive care unit admissions

  7 days

• Duration of stay in hospital

  7 days

Study Arms (1)

Single Group

EXPERIMENTAL

A. Chohan Continuous squeezing Suture (ACCSS): An obstetrical procedure using half circle 40mm round body polyglactin 910 suture # 1 (Vicryl plus by Ethicon ®) for control of haemorrhage from the lower segment, in patients with Placenta Accreta for the prevention of hysterectomy at caesarean section

Procedure: ACCSS

Interventions

ACCSS PROCEDURE

A. Chohan Continuous Squeezing Suture (ACCSS)

Single Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The women at 32 weeks' gestation with central (anterior dominant, posterior) placenta praevia.
• The women with Placenta Accreta Spectrum disorders having myometrial invasion limited to the uterine serosa (Grade 1, 2, and 3a) without involvement of urinary bladder and other pelvic organs.
• The women wishing to conserve the uterus at the time of caesarean section.

You may not qualify if:

• The patients with placenta accreta spectrum disorder with bladder and other organs involvement (Grade 3b, 3c) diagnosed prenatally and during caesarean section.
• The patients with laterally situated right and left placentae.
• The recruited patients who required emergency caesarean section.

Sponsors & Collaborators

• Sharif Medical Research Center: lead

Study Sites (1)

Sharif Medical and Dental college

Lahore, Pakistan/Punjab, 54000, Pakistan

RECRUITING

Related Publications (5)

• Ngwenya S. Postpartum hemorrhage: incidence, risk factors, and outcomes in a low-resource setting. Int J Womens Health. 2016 Nov 2;8:647-650. doi: 10.2147/IJWH.S119232. eCollection 2016.

  PMID: 27843354 RESULT

• Jauniaux E, Gronbeck L, Bunce C, Langhoff-Roos J, Collins SL. Epidemiology of placenta previa accreta: a systematic review and meta-analysis. BMJ Open. 2019 Nov 12;9(11):e031193. doi: 10.1136/bmjopen-2019-031193.

  PMID: 31722942 RESULT

• Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761.

  PMID: 31173360 RESULT

• Huque S, Roberts I, Fawole B, Chaudhri R, Arulkumaran S, Shakur-Still H. Risk factors for peripartum hysterectomy among women with postpartum haemorrhage: analysis of data from the WOMAN trial. BMC Pregnancy Childbirth. 2018 May 29;18(1):186. doi: 10.1186/s12884-018-1829-7.

  PMID: 29843627 RESULT

• Palacios-Jaraquemada JM, Fiorillo A, Hamer J, Martinez M, Bruno C. Placenta accreta spectrum: a hysterectomy can be prevented in almost 80% of cases using a resective-reconstructive technique. J Matern Fetal Neonatal Med. 2022 Jan;35(2):275-282. doi: 10.1080/14767058.2020.1716715. Epub 2020 Jan 26.

  PMID: 31984808 RESULT

MeSH Terms

Conditions

Placenta Accreta; Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Muhammad Arshad Chohan, FRCOG

  Sharif Medical And Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Arshad Chohan, FRCOG

CONTACT

+923004027250; marshadchohan@hotmail.com

Fauzia Butt

CONTACT

+923009427094; drfauziabutt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: November 15, 2021
• Primary Completion: April 14, 2022
• Study Completion: May 31, 2022
• Last Updated: January 19, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)