Does phenobarbital administration to the mothers undergoing IUT, reduce the need for phototherapy and transfusion in their infants.
Design
This phase 3 clinical trial with a control group, with parallel groups, single-blind, randomized using the Random allocation rule is performed on 38 pregnant women.
Settings and conduct
This randomized clinical trial study, which is performed on 38 pregnant women who are candidates for intrauterine transfusion in Yas Hospital from 2021 to 2022. The sampling method is a convenience method.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all pregnant women with 17 to 35 gestational age and negative RH, Fetus with positive RH and alloimmunization and anemia diagnosis, Perinatal indication for intrauterine transfusion.
Criteria for not entering: Existence of any kind of anomaly in the fetus.
Intervention groups
Intervention group: 30 mg phenobarbital is prescribed three times a day, in 10 days till delivery
Main outcome variables
Neonatal jaundice and phototherapy indication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049169N2
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Elham Feizabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8608 9092
Email address
elhamfeizabad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of phenobarbital on the need for blood transfusion and neonatal phototherapy in mothers with IUT
Public title
Comparison of the effect of phenobarbital on the need for blood transfusion and neonatal phototherapy in mothers with IUT
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with 17 to 35 gestational age and negative RH
Fetus with positive RH and alloimmunization and anemia diagnosis
Perinatal indication for intra uterine transfusion
Exclusion criteria:
Existence of any kind of anomaly in the fetus
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 19 letters A and 19 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is performed as single-blind, the pediatric (who assess neonatal jaundice and phototherapy indication), do not know the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2020-12-05, 1399/09/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.850
Health conditions studied
1
Description of health condition studied
Fetal anemia
ICD-10 code
O36.8291
ICD-10 code description
Fetal anemia and thrombocytopenia, unspecified trimester, fetus 1
Primary outcomes
1
Description
Neonatal jaundice
Timepoint
Once
Method of measurement
Pediatric examination and Transcutaneous bilirubinometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the interventional group, 30 mg phenobarbital produced with Marham Daru pharmaceutical co. (two 15 milligram tabs every 8 hours) is prescribed for ten days. According to the time of delivery that is forecasted by the gynecologist, in 10 days till delivery, this drug is prescribed for the pregnant woman.
Category
Treatment - Drugs
2
Description
Control group: In the control group, no additional measures are done and the placebo is not applied.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Rahimi Sharbaf
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Fax
Email
rahimish@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research ofTehran University of Medical Sciences, Dr. Sahraiyan
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi Sharbaf
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
rahimish@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi Sharbaf
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
rahimish@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi Sharbaf
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
rahimish@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Fatemeh Rahimi Sharbaf, and any analysis must be done with her opinion.
From where data/document is obtainable
Fatemeh Rahimi Sharbaf
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Fatemeh Rahimi Sharbaf.