NCT04660578

Brief Summary

Placenta praevia and accreta spectrum 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. A multitude of conservative treatments is described in literature, which includes 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. Such a surgical technique i.e. A. Chohan Continuous Squeezing Suture (ACCSS) is described in this study for controlling haemorrhage from the lower uterine segment at caesarean section for placenta praevia and accrete spectrum disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

November 29, 2020

Last Update Submit

May 2, 2021

Conditions

Placenta Previa With Hemorrhage - DeliveredPlacenta Accreta

Keywords

Postpartum hemorrhagePeripartum hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Peripartum hysterectomy

    Number of peripartum hysterectomies within the study group

    24 hours

Secondary Outcomes (8)

  • Application time of suture in minutes

    within 20 minutes

  • Estimated blood loss

    duration of surgery in minutes

  • Number of units of blood transfusions

    First 24 hours

  • Duration of stay of the participants in hospital in days

    7 days

  • Number of patients requiring other conservative medical and surgical treatments

    Duration of surgery in minutes

  • +3 more secondary outcomes

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 controlling hemorrhage from the lower uterine segment, in patients with placenta previa / accreta for the prevention of hysterectomy at cesarean section.

Procedure: ACCSS

Interventions

ACCSSPROCEDURE

A. Chohan Continuous Squeezing Suture (ACCSS)

Single Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All consenting patients at 32 weeks of gestation, with the diagnosis of placenta previa and placenta accreta spectrum without involvement of bladder and other pelvic organs.
  • Woman who wished to conserve the uterus.

You may not qualify if:

  • Patients were excluded from the study if an emergency cesarean section was done due to severe antepartum hemorrhage before the plan of surgery.
  • Patients with Placenta accreta spectrum with bladder and/or other pelvic organ involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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: 27843354BACKGROUND

  • Mousa HA, Blum J, Abou El Senoun G, Shakur H, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev. 2014 Feb 13;2014(2):CD003249. doi: 10.1002/14651858.CD003249.pub3.

    PMID: 24523225BACKGROUND

  • Dohbit JS, Foumane P, Nkwabong E, Kamouko CO, Tochie JN, Otabela B, Mboudou E. Uterus preserving surgery versus hysterectomy in the treatment of refractory postpartum haemorrhage in two tertiary maternity units in Cameroon: a cohort analysis of perioperative outcomes. BMC Pregnancy Childbirth. 2017 May 30;17(1):158. doi: 10.1186/s12884-017-1346-0.

    PMID: 28558661BACKGROUND

  • Yong S, Pradhan M. Intrauterine Gauze Packing in Primary Post Partum Hemorrhage following Caesarean section: A Clinical study. Nepal J Obstet Gynaecol. 2013;7(1):33-6.

    BACKGROUND

  • D D, Reginald P. Internal uterine tamponade. A Textb Postpartum Hemorrhage. 2006;263-7.

    BACKGROUND

  • B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. Br J Obstet Gynaecol. 1997 Mar;104(3):372-5. doi: 10.1111/j.1471-0528.1997.tb11471.x.

    PMID: 9091019BACKGROUND

  • Selcuk I, Uzuner B, Boduc E, Baykus Y, Akar B, Gungor T. Step-by-step ligation of the internal iliac artery. J Turk Ger Gynecol Assoc. 2019 May 28;20(2):123-128. doi: 10.4274/jtgga.galenos.2018.2018.0124. Epub 2018 Nov 30.

    PMID: 30499283BACKGROUND

  • Wang CY, Pan HH, Chang CC, Lin CK. Outcomes of hypogastric artery ligation and transcatheter uterine artery embolization in women with postpartum hemorrhage. Taiwan J Obstet Gynecol. 2019 Jan;58(1):72-76. doi: 10.1016/j.tjog.2018.11.014.

    PMID: 30638485BACKGROUND

  • Lee HY, Shin JH, Kim J, Yoon HK, Ko GY, Won HS, Gwon DI, Kim JH, Cho KS, Sung KB. Primary postpartum hemorrhage: outcome of pelvic arterial embolization in 251 patients at a single institution. Radiology. 2012 Sep;264(3):903-9. doi: 10.1148/radiol.12111383. Epub 2012 Jul 24.

    PMID: 22829685BACKGROUND

  • Matsubara S, Yano H, Ohkuchi A, Kuwata T, Usui R, Suzuki M. Uterine compression sutures for postpartum hemorrhage: an overview. Acta Obstet Gynecol Scand. 2013 Apr;92(4):378-85. doi: 10.1111/aogs.12077. Epub 2013 Feb 9.

    PMID: 23330882BACKGROUND

MeSH Terms

Conditions

Placenta AccretaPostpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad A Chohan, FRCOG, FCPS

    King Edward Medical University, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 9, 2020

Study Start

February 12, 2019

Primary Completion

August 31, 2020

Study Completion

October 15, 2020

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)