Comparing the effect of progesterone and two different doses of aspirin in reducing uterine artery resistance
Design
This pre-intervention and post-intervention clinical trial study will be performed by using permuted randomization using shuffling cards.
Settings and conduct
In this study, 200 pregnant women between the ages of 18 and 40 who refer to the Dr. Mahzad hospital in Urmia for first-trimester screening, by considering the inclusion criteria, will be included in the study. Then, the participants will be subjected to vaginal color Doppler ultrasound of the uterine arteries by a single perinatologist to determine the mean PI and RI of the uterine arteries and will enter the study by increasing the resistance of the uterine arteries. They will be given aspirin and progesterone for 2 weeks. At the end of two weeks, the cervical artery vaginal ultrasound will be performed again and the mean changes in the PI and RI of the uterine arteries after taking the medication will be evaluated.
Participants/Inclusion and exclusion criteria
Mothers who are in the first 3 months of their pregnancy, do not have a history of abortion and are not emergency patients, and also are not pregnant with multiples will be included in the study. Furthermore, individuals with a body mass index greater than 30 kg/m2, are allergic to aspirin and progesterone, or have taken aspirin or progesterone in the last week, or have a uterine abnormality or a history of gastrointestinal disease will be excluded from the study.
Intervention groups
The first group will consist of patients who will take progesterone suppositories, the second group will consist of people who will take 80 mg aspirin tablets and the third group will consist of people who will take160 mg aspirin tablets.
Main outcome variables
Uterine artery resistance indices (RI and PI) and pregnant outcome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160308026962N5
Registration date:2021-12-23, 1400/10/02
Registration timing:prospective
Last update:2021-12-23, 1400/10/02
Update count:0
Registration date
2021-12-23, 1400/10/02
Registrant information
Name
Tahereh Behroozi Lak
Name of organization / entity
Educational and Treatment Kowsar Center
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 7077
Email address
behroozilak.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of progesterone and two different doses of aspirin effect on refusing uterine artery resistance and pregnancy outcome
Public title
Effect of progesterone and aspirin on refusing uterine artery resistance and pregnancy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is in the first 3 months of pregnancy.
The women who do not have history of abortion.
The women who are not emergency patients.
The women who are not pregnant with multiples.
Exclusion criteria:
Having a body mass index greater than 30 kg/m2.
Having high blood pressure
Disagreeing to participate in the study
Taking Aspirin in the last week
Having Aspirin sensitivity
Having Progesterone sensitivity
Taking Progesterone in the last week
Having a uterine abnormality
Having a history of gastrointestinal disease
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed using permuted randomization using shuffling cards. In this study, 200 cards with equal ratios (50 cards for each group) will be selected. After merging the cards, a card will be taken out and its allocation will be recorded. After re-merging the cards, another card will be removed. This process continued until a random sequence according to the sample size will be reached.
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 Urmia University of Medical Sciences
Street address
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.UMSU.REC1399.402
Health conditions studied
1
Description of health condition studied
Effect of Progesterone and Aspirin on reducing uterine artery resistance and pregnancy outcome
ICD-10 code
ICD-10 code description
Aspirin, Progesterone, uterine artery resistance
Primary outcomes
1
Description
Uterine artery resistance
Timepoint
At the beginning of the study, patients undergoing color Doppler vaginal ultrasounds of the uterine arteries will be placed by a single perinatologist to determine the average PI and RI of the uterine arteries, then they will be given aspirin and progesterone for 2 weeks. At the end of two weeks, the cervical artery vaginal ultrasound will be performed again. The mean changes in the PI and RI of the uterine arteries after taking the medication will be evaluated.
Method of measurement
Checklist before and after intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Progesterone suppository recipient once a day for two weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: 80 mg Aspirin recipient once a day for two weeks
Category
Treatment - Drugs
3
Description
Intervention group 3: 160 mg Aspirin recipient once a day for two weeks
Category
Treatment - Drugs
4
Description
Control group: Patients did not receive any drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mahzad Hospital
Full name of responsible person
Dr. Tahereh Behroozilak
Street address
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3346 5079
Email
behroozila.t@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Golizadeh
Street address
Jahad St., Resalat Blvd., Urmai University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3346 5079
Email
behroozilak.t@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Tahereh Behroozilak
Position
associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3346 5079
Email
behroozilak.t@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Tahereh Behroozilak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3346 5079
Email
behroozilak.t@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Tahereh Behroozilak
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jahad St., Resalat Blvd., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3346 5079
Email
behroozilak.t@umsu.ac.ir
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
There is no more information.
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
Undecided - It is not yet known if there will be a plan to make this available