Protocol summary
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Study aim
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Urologic complication in morbid adherent placenta spectrum hysterectomy after hydrodisection
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Design
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In this research 69 patients with diagnosis of placenta accreta spectrum were chosen purposefully and a code was allocated to each one of them. Then patients were divided into two control (46 patients) and intervention (23 patients) groups by non-random sampling technique
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Settings and conduct
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About 69 patients with diagnosis of placenta accrete spectrum whom are candidate for cesarean hysterectomy in Namazi hospital in Shiraz are chosen and divided to 2 groups. The first one will be managed by simple abdominal hysterectomy while the other will be managed by hydrodissection of bladder before hysterectomy.
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Participants/Inclusion and exclusion criteria
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All pregnant women with diagnosis of placenta accrete spectrum who are candidate for cesarean hysterectomy in Namazi hospital are chosen and women with focal accrete will be excluded
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Intervention groups
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The surgical approach in control group will be simple abdominal hysterectomy while in case group we will use hydrodisection before hystrectomy
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Main outcome variables
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Bladder injury , Ureter injury
General information
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Reason for update
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The sample size should be corrected
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160130026260N3
Registration date:
2022-03-08, 1400/12/17
Registration timing:
prospective
Last update:
2024-03-23, 1403/01/04
Update count:
1
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Registration date
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2022-03-08, 1400/12/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-16, 1400/12/25
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Expected recruitment end date
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2024-02-20, 1402/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Urologic complication in morbid adherent placenta spectrum hysterectomy after hydrodisection
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Public title
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Urologic complication of hysterectomy in morbid placenta accreta after hydrodisection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Pregnant women with aged between 20-45 years
Gestational aged between 12 and 40 weeks
All cases had histology-confirmed placenta accrete spectrum
Exclusion criteria:
Patient with focal accreta
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
69
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-01-10, 1400/10/20
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Ethics committee reference number
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IR.SUMS.REC.1400.721
Health conditions studied
1
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Description of health condition studied
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Placenta accrete spectrum refers to the range of pathologic adherence of the placenta including placenta increta , percreta and accrete can cause maternal morbidity and mortality because of severe hemorrhage
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ICD-10 code
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O43.21
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ICD-10 code description
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Placenta accreta
Primary outcomes
1
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Description
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Bladder injury
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Timepoint
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during operation
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Method of measurement
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Methylene blue test
2
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Description
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Ureter injury
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Timepoint
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during operation
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Method of measurement
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Intraoperative clinical examination
Secondary outcomes
1
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Description
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Determination of bladder hydrodisection role in reducing blood loss during surgery
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Timepoint
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During surgery
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Method of measurement
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Minutes
2
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Description
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Determination of bladder hydrodisection role in reducing blood loss during surgery
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Timepoint
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During surgery
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Method of measurement
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Cc of blood lost
Intervention groups
1
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Description
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Intervention group: The intervention group is women who underwent bladder hydrodisection with diluted epinephrine 1 in 10,000 with normal saline 0.9 injection in a bladder filled with 200 cc normal saline after the baby is born and before the hysterectomy begins.
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Category
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Treatment - Surgery
2
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Description
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Control group: case group we will use hydrodisection before hystrectomy
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Surgery results
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When the data will become available and for how long
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End of august 2022
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To whom data/document is available
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healthcare professional- َacademic members of universities
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Under which criteria data/document could be used
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An official request from the organization
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From where data/document is obtainable
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To researchers responsible for responding to this plan Address: Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran Tel: +98-71-36128257,+98-36122285 Fax: 07136479830 postal code: 7193635899
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What processes are involved for a request to access data/document
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Request to Vice-Chancellor for Research and Technology Affairsو Written request Coordinated by the ethics committee 2 months
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Comments
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