The aim of our study is to determine the effectiveness of aspirin in redusing the prevention of preeclampsia in pregnant women with abnormal findings at uterine artery Doppler velocimetry perfume at 11-14 weeks.The design is randomized controlled clinical trial.All participants will attended the antenatal clinic in Emam hospital of Sari during the period from 1392-1393 years.In addition to the routine ultrasound will done in all participants to evaluate the pregnancy at the time of booking.All patients have Doppler velocimetry of the uterin artery either by transabdominal or transvaginal route.The outcome measures will the resistance index and palsatility index of the uterine artery.Patients show to have normal Doppler findings will excluded,wheras those with abnormal results(the presence of unilateral or bilateral uterin artery resistance index higher than 90th percentile for age)will explaired the whole procedure.The number of 100 patients agree to sign consent and they will randomly dividing in two groups.Group1(50 patients)will treated with acetylsalicylic oral tablets and the control group(50 patients)will not give any treatment.All women will followup until delivery to assess maternal perinatal outcoms.They will also monitor for blood pressure and proteinuria on regular basis.The primery outcome criteria will the development preeclampsia,time of onset,criteria of severity.The second outcome criteria will intrauterine growth restriction,preterm delivery,still birth and maternal bleeding that need to transfusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072914198N1
Registration date:2013-09-14, 1392/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-14, 1392/06/23
Registrant information
Name
Zoleikha Atarod
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
zatarod@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2013-06-01, 1392/03/11
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Using of low dose aspirin in the prevention of preeclampsia in pregnant women with abnormal uterin Doppler at 11-14 weeks gestation
Public title
Using of aspirin in the prevention of preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Singleton pregnancies at 11-14 weeks and with riskfactors for preeclampsia such as;nulliparous women.
Exclusion criteria;Fetal chromosomal or structural abnormalities,allergy to acetylsalicylic tablets,medical conditions:renal,lupus and coronary artery heart disease,bleeding disorders.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Mazandaran University of Medical Sciences
Street address
Emam hospital, Sari
City
Sari
Postal code
Approval date
2013-02-27, 1391/12/09
Ethics committee reference number
1517
2
Ethics committee
Name of ethics committee
Mazandaran university of medical sciences
Street address
Emam hospital
City
sari
Postal code
Approval date
2013-02-27, 1391/12/09
Ethics committee reference number
1517
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
2
Description of health condition studied
preeclampsia
ICD-10 code
O14.0,O14.
ICD-10 code description
پره اکلامپسی خفیف-پره اکلامپسی شدید-پره اکلامپسی با علایم غیر اختصاصی
Primary outcomes
1
Description
Diagnosis of preeclampsia
Timepoint
2 month after onset-every 4 week-End of treatment
Method of measurement
Monitor of blood pressure and proteinuria
2
Description
Time of onset of preeclampsia
Timepoint
2 month after onset-every 4 week-End of treatment
Method of measurement
LMP and ultrasound at time of booking
3
Description
Criteria of severity of preeclampsia
Timepoint
2 month after onset-every 4 week-End of treatment
Method of measurement
Monitor for blood pressure and proteinuria and symptoms and signs
Secondary outcomes
1
Description
Maternal bleeding that need to transfusion
Timepoint
From delivery for 24 hours after
Method of measurement
Signe and symptoms-decreasing of Hb after delivery-nu
2
Description
Intrauterine growth restriction
Timepoint
2ماه بعد از شروع مطالعه-هر 4 هفته-پایان مطالعه
Method of measurement
When the fetal weight will below the 10th percentile for gestational in ultrasound and also when the neonatal birth weight will fill bellow the 10th percentile
3
Description
Preterm delivery
Timepoint
2 month after onset-every 4 week-End of treatment
Method of measurement
LMP and ultrasound at time of booking
4
Description
Still birth
Timepoint
2 month after onset-every 4 week-End of treatment
Method of measurement
With FHR monitoring and ultrasound
Intervention groups
1
Description
Intrvention description:Tab ASA 80 mg daily after lunch
Category
Treatment - Drugs
2
Description
Controlled trial:No treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Mohamadreza Shiran
Street address
Juibar forked road, Emam square, Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Zoleikha Atarod
Position
Obstetrician
Other areas of specialty/work
Street address
Emam hospital
City
Sari
Postal code
Phone
+98 15 1226 1700
Fax
Email
zatarod@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Zoleikha Atarod
Position
Obstetrician
Other areas of specialty/work
Street address
Emam hospital
City
Sari
Postal code
Phone
+98 15 1226 1700
Fax
Email
zatarod@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Lale Ahari Kiani
Position
Rezident
Other areas of specialty/work
Street address
Emam hospital
City
Sari
Postal code
Phone
00
Fax
Email
l_kiani_59@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)