Evaluating the effect of aspirin on the occurrence of PLP, IUGR and preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancies in Khalije fars hospital Bandar abbas,Iran in 2016-2017
The effect of aspirin on the incidence of PLP, IUGR and preeclampsia in pregnant women with a history of preeclampsia in previous pregnancies.
Design
According to the table output of the Random Allocation software, the patients were randomly divided into two groups: an intervention group at the gestational age of 12 to 15 weeks treated with 80 mg of aspirin on a daily basis, and a control group that received routine medical treatment. In the former group, the treatment continued up until the 36th week of pregnancy
Settings and conduct
The present research was a randomized clinical trial conducted on 86 patients with a history of preeclampsia in previous pregnancies of those visiting Khalij Fars Hospital in Bandar Abbas in 2017. The patient participants were selected in a convenient and purposive sampling method.
Participants/Inclusion and exclusion criteria
The inclusion criteria includes all pregnant women with a history of preeclampsia in previous pregnancies. Exclusion criteria include a pregnant women with multiple pregnancy; gestational diabetic; history of previous PLP, and polyhydroaminosis; history of other systemic diseases (such as hypertension); history of coagulation disorders; use of anticoagulant drugs and aspirin susceptibility.
Intervention groups
The intervention group was treated with a daily amount of 80 mg of aspirin.
Main outcome variables
IUGR
PLP
Preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181218042033N1
Registration date:2019-01-20, 1397/10/30
Registration timing:retrospective
Last update:2019-01-20, 1397/10/30
Update count:0
Registration date
2019-01-20, 1397/10/30
Registrant information
Name
Nazanin Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 3280
Email address
abdinazanin834@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2018-08-21, 1397/05/30
Trial completion date
2018-08-21, 1397/05/30
Scientific title
Evaluating the effect of aspirin on the occurrence of PLP, IUGR and preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancies in Khalije fars hospital Bandar abbas,Iran in 2016-2017
Public title
Effect of aspirin on the occurrence of PLP, IUGR and preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women with a history of preeclampsia in previous pregnancies
Exclusion criteria:
Multiple Pregnancy
Gestational Diabet
History of previous PLP
Polyhydraminosis
History of other systemic diseases (such as hypertension),
History of coagulation disorders
Use of anticoagulant drugs
Aspirin susceptibility
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Actual sample size reached:
86
Randomization (investigator's opinion)
N/A
Randomization description
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 Homozgan University of medical sciences
Street address
HUMS, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
HUMS.REC.1396.89
Health conditions studied
1
Description of health condition studied
Intrauterine growth restriction
ICD-10 code
o36.5
ICD-10 code description
IUGR
2
Description of health condition studied
Preterm Labor Pain
ICD-10 code
o60
ICD-10 code description
Preterm labor
3
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Preterm delivery, IUGR, Preeclampsia
Timepoint
After completing the research
Method of measurement
Study the case
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: an intervention group at the gestational age of 12 to 15 weeks treated with 80 mg of aspirin on a daily basis
Category
Treatment - Drugs
2
Description
Control group: a control group that received routine medical treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hormozgan University of Medical Sciences
Full name of responsible person
Naznin Abdi
Street address
HUMS, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 71 3647 9830
Email
abdinazanin834@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abdolazim Nejati Zadeh
Street address
HUMS, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3647 9830
Email
azimnejate@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Afsaneh RozRokh
Position
Resedient
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
HUMS, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3647 9830
Email
afroozrokh1988@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nazanin Abdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
HUMS, Chamran Blvd, Bandar abbas
City
Banndar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 736479830
Email
abdinazanin834@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nazanin Abdi
Position
Assistatnt professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
HUMS, Chamran Blvd, Bandar abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 36479830
Email
nazanin.abdi57@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2018 Ethic form: 2018
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Hormozgan university of medical sciences Ethic form: OB & Gyn ward Hormozgan university of medical sciences
What processes are involved for a request to access data/document