Determination the outcomes of hypo gastric arterial ligation before hysterectomy in patients with placenta accreta compare with control group
Design
controlled single blind clinical trial
Settings and conduct
In this study, 35 patients in each group (intervention and control groups) and a total of 70 patients with placenta accreta candidate for hysterectomy referring to Isfahan Alzahra Hospital include in the study. The intervention is hypogastric artery ligation prior to hysterectomy for intervention group. Then, the amount of bleeding, frequency of deep vein thrombosis, amount of used blood products during surgery, time of surgery and the duration of hospitalization between two groups will compare. Data analysis will perform using the software SPSS (version 25).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Diagnosis of placenta accreta disease by two experienced gynecologists by Color Doppler Ultrasonography
2. Awareness of the patient and her/his family from the study and signing the consent form
Exclusion criteria:
1. Patient's dissatisfaction for participant in the study
Intervention groups
Intervention group is consist of pregnant women with placenta accreta disorder candidate for hysterectomy that undergo hypo-gastric arterial ligation before hysterectomy. Control group is consist of pregnant women with placenta accreta disorder candidate for hysterectomy that do not undergo hypo-gastric arterial ligation before hysterectomy.
Main outcome variables
The amount of blood loss during operation, frequency of deep vein thrombosis, amount of used blood products during operation, time of operation and hospitalization time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190123042467N1
Registration date:2019-06-14, 1398/03/24
Registration timing:registered_while_recruiting
Last update:2019-06-14, 1398/03/24
Update count:0
Registration date
2019-06-14, 1398/03/24
Registrant information
Name
Minoo Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 8092
Email address
minoomovahedi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the outcomes of hypogastric arterial ligation before hysterectomy in patients with placenta accreta compare to healthy control
Public title
Investigation of hypo gastric arterial ligation in placenta accreta disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ِDiagnosis of placenta accreta disease by two experienced gynecologists by Color Doppler Ultrasonography
Awareness of the patient and her/his family from the study and signing the consent form
Exclusion criteria:
Patient's dissatisfaction for participating in the study
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study the patients were kept blind, which means they did not know which surgery was received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commite of Isfahan university of medical siences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.MUI.MED.REC.1397.156
Health conditions studied
1
Description of health condition studied
Placenta adherent disorder
ICD-10 code
O72.0
ICD-10 code description
Third-stage hemorrhage
Primary outcomes
1
Description
Amount of blood loss during operation
Timepoint
Immediately after intervention
Method of measurement
The amount of blood inside the aspirator
2
Description
Frequency of deep vein thrombosis
Timepoint
Seven days after operation
Method of measurement
Duplex ultrasonography
3
Description
Amount of used blood products during operation
Timepoint
End of operation
Method of measurement
Direct counting
4
Description
Operation time
Timepoint
End of operation
Method of measurement
Timer
5
Description
Time of hospitalization
Timepoint
Seven days after operation
Method of measurement
Investigation of medical record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group is consist of pregnant women with placenta accreta disorder who are candidate for hypo-gastric arterial ligation before hysterectomy.
Category
Treatment - Surgery
2
Description
Control group: Control group is consist of pregnant women with placenta accreta disorder who are not candidate for hypo-gastric arterial ligation before hysterectomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Minoo Movahedi
Street address
Soffeh Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0044
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo javanmardi
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Niakan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
niakanzahra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mino Movahedi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
minoomovahedi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Niakan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
niakanzahra@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"No more information"
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available