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Evaluation of bilateral hypogastric artery occlusion on the volume of bleeding in patients with abnormal placental adhesions

Protocol summary

Study aim
Determining the effect of bilateral hypogastric artery occlusion on the bleeding rate of patients with abnormal placental adhesion referred to Imam Sajjad Hospital, Yasuj, Iran
Design
A randomised clinical trial with two intervention groups, with parallel groups, without blinding, on 40 patients, and kitset.ir website was used for randomization.
Settings and conduct
40 patients who referred to the Women's Clinic of Imam Sajjad Hospital in Yasuj, were randomly divided into two groups without blinding: hysterectomy with bilateral hypo-gastric artery ligation and hysterectomy alone (20 patients in each group). The duration of surgery, total amount of blood loss during surgery, duration of hospitalization, need to blood products transfusion during surgery, and visceral trauma were investigated between the two groups.
Participants/Inclusion and exclusion criteria
Patients with abnormal placental adhesion in the form of: 1) Multiple lacunae, 2) Loss of the retro placental area, 3) Abnormalities of the serous connection of the bladder and uterus, which will be identified through trans-abdominal and trans-vaginal ultrasound by referring to a sonographist.
Intervention groups
The selected samples were divided into two groups of people with abnormal placental adhesion who used hypogastric artery ligation during surgery (group 1) and the group who underwent caesarean section and hysterectomy without hypogastric artery ligation (group 2).
Main outcome variables
The amount of bleeding during the operation; the amount of blood received; The duration of hospitalization after the operation; the duration of the operation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230101057014N1
Registration date: 2023-02-04, 1401/11/15
Registration timing: retrospective

Last update: 2023-02-04, 1401/11/15
Update count: 0
Registration date
2023-02-04, 1401/11/15
Registrant information
Name
mehrnaz kherad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3837 0829
Email address
dr.mehrnaz.kherad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2021-11-06, 1400/08/15
Actual recruitment end date
2022-08-05, 1401/05/14
Trial completion date
2022-08-05, 1401/05/14
Scientific title
Evaluation of bilateral hypogastric artery occlusion on the volume of bleeding in patients with abnormal placental adhesions
Public title
Bilateral hypogastric artery occlusion on the volume of bleeding in patients with abnormal placental adhesion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with abnormal placental adhesion with Multiple Lacuna Patients with abnormal placental adhesion due to loss of the retroplacental region Patients with abnormal placental adhesion that abnormalities of the serous connection of the bladder and uterus, which will be identified through trans-abdominal and trans-vaginal ultrasonography by referring to the sonographist.
Exclusion criteria:
Cases that have a high risk for bleeding during surgery include bleeding disorders (such as hemoglobinopathies, and thrombocytopenia) Cases receiving anticoagulant treatment, etc Cases of abnormal invasive placenta that require quick termination of pregnancy, such as heavy bleeding in the emergency department of people who have underlying diseases such as diabetes, blood pressure disorders, heart diseases, etc. Those who refused to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly select the treatment method using the kitset.ir website patients were divided into two groups and placed in their own group at the beginning of the study. In this way, first a number is considered for each patient and the first and last number and the desired number of numbers are entered in the relevant part of the mentioned site and by clicking on the number generation option, the numbers are given to us selectively and randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Deputy of research and technology of Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.YUMS.REC.1400.127

Health conditions studied

1

Description of health condition studied
Abnormal placental adhesion
ICD-10 code
O00.0
ICD-10 code description
Abdominal pregnancy

Primary outcomes

1

Description
The amount of bleeding volume during the surgery
Timepoint
During the surgery
Method of measurement
In order to estimate the volume of blood lost during the surgery, the volume of liquid collected in the suction device, the difference in the weight of clean and soaked in blood gauze and lung gauze and the number of towels used to control the bleeding were used.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the hypo-gastric artery ligation group, first 10 units of oxytocin are used to eutronicize the uterus, and in case of high suspicion of placental adhesion, the patient's bleeding is controlled by bilateral hypogastric artery ligation. An oncologist starts the surgery by opening the posterior peritoneum that covers the bifurcation of the common iliac vessels. Then, bilateral hypo-gastric artery ligation steps are carefully performed. Before performing this surgery and also after closing the hypogastric artery, checking the femoral pulse on both sides is done.
Category
Treatment - Surgery

2

Description
Intervention group: In the hypo-gastric artery group without ligation, cesarean surgery and hysterectomy are performed. The cesarean surgery starts by cutting the skin from the mid-line until exposing the uterus, and the fetus is delivered through the classical upper section. The umbilical cord is cut and closed by using a Kokher clip.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Sajad Hospital
Full name of responsible person
Parvin Ghaffari
Street address
Next to Azadi hotel, Yasuj city, Kohgiluyrh and Boyer-Ahmad province.Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3222 0163
Email
Emamsajad@gmail.com
Web page address
https://emamsajad.yums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyyed Amin Hosseini
Street address
Deputy of research and technology of Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
en@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghaffari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 71 3837 0829
Email
pari.ghaffari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Parvin Ghaffari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 71 3837 0829
Email
pari.ghaffari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shekoofeh Nikooei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Yasuj University of Medical Sciences, Shahid Motahari boulvared, Yasuj city, Kohgiluyeh and Boyer-Ahmad Province, Iran.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 71 4452 6867
Email
shekoofeh.nikooei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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