The aim of this study is determining the effect of aspirin in pregnancy outcome in pregnant women with abnormal screen tests of Down syndrome and normal karyotype. This is a randomized clinical trial on 85 patients referred to prenatal clinic of Afzalipoor Hospital of Kerman.
Inclusion criteria: pregnant women with abnormal biochemical tests in second trimester which have normal karyotype; agreement of the patients.
Exclusion criteria: history of sensitivity to aspirin; asthma; Peptic ulcer; renal failure; gout; multifetal pregnancy; gestational diabetes; hemorrhage in first half of pregnancy; maternal disorders; congenital anomalies.
In intervention group, 80 mg aspirin (daily) is administered until week 34 of pregnancy. In both groups bilateral uterine artery Doppler is performed by a gynecologist who is blind to groups.
Finally the outcomes of pregnancy in all patients is evaluated and collected in data sheet record. The abnormal outcomes of pregnancy are: preterm labor, intrauterine death, intrauterine restricted growth, preeclampsia, Placental abruption, and oligohydramnios.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120620218N1
Registration date:2015-01-03, 1393/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-03, 1393/10/13
Registrant information
Name
Fatemeh Mirzaee
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 342322250
Email address
s_mirzai@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Aspirin in pregnancy outcomes in patients with abnormal down syndrome biochemical tests and with normal karyotype
Public title
The effect of Aspirin in pregnancy outcome in patients with abnormal down syndrome blood tests and normal karyotype
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with abnormal biochemical tests in second trimester which have normal karyotype; consent of the patients.
Exclusion criteria: history of sensitivity to aspirin; asthma; Peptic ulcer; renal failure; gout; multifetal pregnancy; gestational diabetes; hemorrhage in first half of pregnancy; maternal disorders; congenital anomalies.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Kerman University of Medical sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2014-11-29, 1393/09/08
Ethics committee reference number
k/93/299
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
P00-P96
ICD-10 code description
Fetus and newborn affected by maternal factors and by complications of pregnancy, labour and delivery
Primary outcomes
1
Description
preterm labor
Timepoint
at birthday
Method of measurement
calculated from the number of completed weeks since the first day of the mother's last menstrual period to the date of birth.
2
Description
fetal death
Timepoint
during pregnancy
Method of measurement
examination of fetus
3
Description
Intra uterine Growth Restriction
Timepoint
after delivery
Method of measurement
based on age and weight
4
Description
preeclampsia
Timepoint
every two weeks
Method of measurement
patient visit and blood pressure checking
5
Description
Placental abruption
Timepoint
at birthday
Method of measurement
examination of fetus
Secondary outcomes
1
Description
oligohydramnios
Timepoint
during pregnancy
Method of measurement
examination of fetus
Intervention groups
1
Description
In intervention group: Administration of 80 mg Aspirin tablet daily until 34th week of gestation.
Category
Treatment - Drugs
2
Description
control group: no aspirin administration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Manijeh Assaran
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Manijeh Assaran
Position
Assistant of gynecology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
00
Fax
Email
m.assaran1356@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Mirzai
Position
gynecologist
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 43 1322 2250
Fax
Email
s_mirzai@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Manijeh Assaran
Position
Assistant of gynecology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
00
Fax
Email
m.assaran1356@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)