The goal of this study is the evaluation of the effect of low dose aspirin (80 milligram) administration, on pregnancy outcome in those complicated with unexplained increased Alpha-fetoprotein. Pregnant women with positive second trimester screening test for Neural Tube Defect (NTD) will included in study and will evaluated via targeted ultrasonography for fetal anomalies, Doppler of uterine arteries, vaginal ultrasonography for cervical incompetency and alpha-fetoprotein retest in maternal serum. Patients with single tone pregnancy and alpha-fetoprotein (AFP) value ≥ 2.50 MoM (multiples of the median) will divided into two groups respect of uterine arteries Doppler (One group with diastolic notch or increased uterine artery resistance (n=100), and another group with normal uterine arteries (n=100) ). Each groups will divided into Aspirin treated group (n=50) and control group (n=50) with Random Allocation software. Aspirin will continue until 34 weeks of pregnancy. The outcome of pregnancy on preterm birth, fetal death, preeclampsia, fetal growth restriction (IUGR) and neonatal admission will be considered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042017365N1
Registration date:2015-05-05, 1394/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-05, 1394/02/15
Registrant information
Name
Fatemeh Bahadori
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 7077
Email address
fbahadory27@yahoo.com
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-07-24, 1393/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low dose Aspirin in Prevention of Adverse Pregnancy Outcomes in Women with Unexplained Elevated alpha-protein in second trimester screening
Public title
Effect of administration low dose aspirin on pregnancy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with Second-trimester positive screening test for Neural Tube Defect and alpha-fetoprotein ≥ 2.5 MOM.
Exclusion criteria: Women with positive Thrombophili; Thrombocytopenia; Structural or Chromosomal anomalies of the fetus; Placental hematoma; Early severe IUGR; Multiple pregnancies; Ultrasonographic sign of cervical incompetency.
Age
From 18 years old to 45 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
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
Urmia, Urmia University of Medical Sciences
Street address
Urmia, Urmia University of Medical Sciences
City
Urmia
Postal code
Approval date
2013-08-20, 1392/05/29
Ethics committee reference number
Umsu.rec1390-50
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
014.9
ICD-10 code description
Gestationa l(pregnancy induced) hypertension with significant proteinuria
2
Description of health condition studied
Preterm Labar
ICD-10 code
060.1
ICD-10 code description
Preterm spontaneous labour with preterm delivery
3
Description of health condition studied
IUGR
ICD-10 code
P05.0
ICD-10 code description
Usually referred to as weight below but length above 10th centile for gestational age.
4
Description of health condition studied
Intra Uterine Fetal Death
ICD-10 code
036.4
ICD-10 code description
Intra Uterine Fetal Death
5
Description of health condition studied
Addmision in NICU or Neonatal Ward
ICD-10 code
P01.9
ICD-10 code description
Ernal complication of pregnancy, unspecified
Primary outcomes
1
Description
Neonatal weight respect of gestational age at delivery
Timepoint
Post delivery
Method of measurement
Wight of neonate less than 10 % percentile for gestational age and sign of IUGR
2
Description
Gestational age at delivery
Timepoint
Past delivery
Method of measurement
Birth of neonate before 37 complete weeks
3
Description
Neonatal admision time
Timepoint
Past delivery
Method of measurement
Days of neonatal admission in neonatal ward or neonatal intensive care unit
4
Description
Fetal daeth
Timepoint
Visits in pregnancy
Method of measurement
Non live fetus in uterine period after 20 weeks of gestational age
5
Description
Preeclampsia
Timepoint
Prenatal visits
Method of measurement
Maternal blood presure of>= 140/90 plus proteinuria (>300 milligram in 24 hours urine)
Secondary outcomes
empty
Intervention groups
1
Description
Low dose Aspirin (80 mg) administrated from study time until 34 weeks of pregnancy, compared with control group (no Aspirin)
Category
Treatment - Drugs
2
Description
No additional treatment for control group
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari Hospital
Full name of responsible person
Fatemeh Bahadori
Street address
Kowsar center, Motahhari Hospital, Kashani St., Urmia
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Ghafarzade Miss
Street address
Research Ward, Setad, Urmia Medical Sciences University
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Bahadori Fatemeh
Position
Associate Professore
Other areas of specialty/work
Street address
Motahhari Hospital
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
fbahadory27@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Bahadori Fatemeh
Position
Perinatology Fellowship
Other areas of specialty/work
Street address
Motahhhari Hospital
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
fbahadory27@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Bahadori Fatemeh
Position
Associate Professors
Other areas of specialty/work
Street address
Motahhari Hospital
City
Urmia
Postal code
Phone
+98 44 3223 7077
Fax
Email
fbahadory27@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)