This study is a prospective and randomized single-blind clinical trial. The aim of this study is role of hemoglobin and the effect of it’s correction on pregnancy outcome in minor and intermedia thalassemia patients. Total of sample size is 36 patient with ages: 20-35 years old. Inclusion criteria are thalassemia minor and intermedia women and pregnant
With hemoglobin over 8.5. The patients with metabolic diseases such as cushing syndrome and chronic diseases such as rheumatic disease and age over 35 years will be excluded. The patients are randomly divided into two groups by blocked randomization. Assessor of study do not know about grouping patients. This study is 3 trial phase. First group receives One or several packed cells (Bag of packed red blood cells) based on hemoglobin of body. The second group as a control group does not receive anything. Both groups receives pharmaceutical plan such as folic acid and ferrous sulfate according to hematologists. Hemoglobin all patients and fetal health status is checked once every two weeks. Patients information such as age, BMI, spontaneous abortion and stillbirth, oligohydramnios, fetal anomalies, SGA, LBW, VLBW, baby delivery method, preterm delivery, the number of packet cell will be recorded in both groups during pregnancy and after baby delivery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010825903N1
Registration date:2016-02-18, 1394/11/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-18, 1394/11/29
Registrant information
Name
Mahin Bahadori
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
bahadori.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-01-25, 1394/11/05
Expected recruitment end date
2016-07-26, 1395/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of hemoglobin and the effect of it’s correction on pregnancy outcome in minor and intermedia thalasemia patients
Public title
Evaluation of hemoglobin in pregnant women with thalassemia minor and intermedia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: thalassemia minor and intermedia women and pregnant
With hemoglobin over 8.5; Bearing a singleton baby; Patient with ages: 20-35 years old.
Exclusion Criteria: Patients with metabolic diseases such as cushing syndrome, Hypothyroidism and hyperthyroidism; chronic diseases such as rheumatic disease, autoimmune and antiphospholipid syndrome.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
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
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.AJUMS.REC.1394.562
Health conditions studied
1
Description of health condition studied
thalassaemia
ICD-10 code
D56.1
ICD-10 code description
Cooley anaemia, Severe beta thalassaemia, Thalassaemia: Intermedia, major
2
Description of health condition studied
Pregnancy
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Stillbirth
Timepoint
Once each month, during pregnancy
Method of measurement
Patient appointments
2
Description
spontaneous abortion
Timepoint
Once each month, during pregnancy
Method of measurement
Patient appointments
3
Description
The amount of hemoglobin
Timepoint
Before intervention and once each month
Method of measurement
Venous sampling and sent to the laboratory
4
Description
oligohydramnios
Timepoint
Once each month, during pregnancy
Method of measurement
sonography
5
Description
Fetal anomaly
Timepoint
Once each month, during pregnancy
Method of measurement
sonography
6
Description
baby delivery method
Timepoint
during baby delivery
Method of measurement
Patient appointments and record baby's birth
7
Description
SGA (small for gestational age
Timepoint
Once each month, during pregnancy
Method of measurement
sonography
8
Description
VLBW (Very low birth weight)
Timepoint
during baby delivery
Method of measurement
Patient appointments and record uterine contractions
9
Description
The number of pack cell required for injection
Timepoint
Once each month, during pregnancy
Method of measurement
Patient appointments and record
Secondary outcomes
1
Description
Blood transfusion complication (nausea, vomiting, fever and chills)
Timepoint
During the transfusion and 2 hours after blood transfusion
Method of measurement
Oral questionnaire and patient response
Intervention groups
1
Description
Intervention group: Prescription One or several packed cells (Bag of packed red blood cells) ) based on hemoglobin of body during surgery
Category
Treatment - Drugs
2
Description
Control group 2:
The second group as a control group does not receive anything
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khomeini Hospital
Full name of responsible person
Ahmad Ahmadzadeh asl
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
2
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Mozhgan Barati
Street address
Shafa Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahin Bahadori
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Bahadori.md10@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mahin Najafian
Position
Obstetrician and Gynaecology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Dr.m1377@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
-
Phone
+32 222922
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)