Assessing the clinical effects of a short-term course of Oral Furosemide in postpartum period in patients with preeclampsia during pregnancy : A Randomized Controlled Trial
Examining the prevalence of persistent hypertension on the 5th day after delivery or the day the patients were discharged from the hospital (whichever occurred earlier)
Design
A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial in 118 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The study was conducted in an academic hospital affiliated to Iran University of Medical Sciences. Blinding was performed on the patients. Patients will be randomized and one group will be prescribed only angiotensin inhibitor drugs and the other group will be prescribed furosemide drugs in addition to this drug. The groups will then be compared with each other in terms of specified clinical outcomes
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with recent pregnancy which was complicated with preeclampsia. patients under 18 and those with renal disease or history of hypertension or history of congenital heart defects will be excluded
Intervention groups
Women with recent pregnancy who had high blood pressure during pregnancy. In the intervention group, in addition to the usual treatment, which includes the administration of angiotensin receptor blockers, low-dose furosemide is prescribed. In the control group, only angiotensin receptor blocking drugs will be prescribed
Main outcome variables
Prevalence of persistent hypertension in day 5 post partum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230722058884N1
Registration date:2023-11-30, 1402/09/09
Registration timing:registered_while_recruiting
Last update:2023-11-30, 1402/09/09
Update count:0
Registration date
2023-11-30, 1402/09/09
Registrant information
Name
Maliheh Fakehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 6034
Email address
maryam.fakehi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the clinical effects of a short-term course of Oral Furosemide in postpartum period in patients with preeclampsia during pregnancy : A Randomized Controlled Trial
Public title
Effect of Oral Furosemide on patients with preeclampsia during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have had a recent pregnancy with preeclampsia
Exclusion criteria:
Age under 18
Patients with prior history of hypertension
Patients with renal disease
Patients with history of congenital heart defects
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization protocol for this clinical trial is designed to ensure the unbiased allocation of participants into different treatment groups. Prior to the start of the trial, a computer-generated randomization list will be created by an independent statistician who is not involved in the recruitment or allocation process. Using this list, participants will be assigned to one of two treatment arms in a random manner. The randomization process will not be stratified The allocation sequence will be concealed from the researchers, participants, and study personnel until the intervention is assigned. This rigorous randomization process reduces the likelihood of selection bias, increases internal validity, and allows for a more accurate assessment of the treatment effects in the subsequent analysis.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study only the patients will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University if Medical Sciences
Street address
Beside Milad Tower, Hemmat highway,
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-07-13, 1401/04/22
Ethics committee reference number
IR.IUMS.FMD.REC.1401.224
Health conditions studied
1
Description of health condition studied
Unspecified pre-eclampsia
ICD-10 code
O14.9
ICD-10 code description
Unspecified pre-eclampsia
Primary outcomes
1
Description
Prevalence of persistent hypertension in day 5 post partum
Timepoint
Day 5 post partum
Method of measurement
Manual sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with preeclampsia who are treated with ARB plus low does Furosemide
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Parisa Hajari
Street address
Beside Molavi Subway Station, Molavi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
parisa.hajari72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Mousavizadeh
Street address
Beside Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86710
Email
mousavizadeh.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parisa Hajari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No.57, Shahrivar Avenue, North Karegar Street
City
Tehran
Province
Tehran
Postal code
1457713611
Phone
+98 21 6604 4657
Email
parisa.hajari72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hajari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 57, Shahrivar Street, North Karegar Aveneu
City
Tehran
Province
Tehran
Postal code
1457713611
Phone
+98 21 6604 4657
Email
parisa.hajari72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Hajari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 57, Shahrivar Street, North Karegar Avenue
City
Tehran
Province
Tehran
Postal code
1457713611
Phone
+98 21 6604 4657
Email
parisa.hajari72@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