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The delayed umbilical cord clamping effects on early outcome in Preterm neonates

Protocol summary

Study aim
The effect of delayed umbilical cord clamp on early complications in premature infants
Design
Mothers were divided into 2 clamper groups in seconds 30 and 180 seconds using simple randomization and in parallel groups.
Settings and conduct
After the approval of the plan and the necessary coordination, all pregnant mothers who are eligible criteria will be given written consent after full explanation. Demographic and pregnancy data are entered from the case and pregnancy booklet and interviewed in a pre-filled questionnaire. Mothers are divided into 2 groups of clamps in seconds 30 and 180 seconds. After delivery and clamping of the patients in terms of neonatal blood parameters, weaning from ventilator, NICU discharge time, need for surfactant and neonatal complications including Cerebral Palsy, Retinopathy Of Prematurity, Broncho Pulmonary Dysplasia, Respiratory Distress Syndrome, Intra Ventricular Hemorrhage will be evaluate. Finally, after collecting the data, we provide them with a statistical expert for analysis.
Participants/Inclusion and exclusion criteria
Pregnant women with preterm pregnancy (28 to 37 weeks) exclusion criteria: The presence of underlying maternal disease such as preeclampsia, diabetes, blood disorders, heart disease Hemoglobin less than 11 bleeding due to Premature separation of placenta more than one fetus
Intervention groups
Mothers are divided into 2 groups of clamps in seconds 30 and 180 seconds.
Main outcome variables
After delivery and clamping of the patients , blood parameters, weaning from ventilator, NICU discharge time, need for surfactant and neonatal complications including Cerebral Palsy, Retinopathy Of Prematurity, Broncho Pulmonary Dysplasia, Respiratory Distress Syndrome, Intra Ventricular Hemorrhage will be evaluate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141208020249N2
Registration date: 2018-07-01, 1397/04/10
Registration timing: retrospective

Last update: 2018-07-01, 1397/04/10
Update count: 0
Registration date
2018-07-01, 1397/04/10
Registrant information
Name
Behzad Khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 9697
Email address
khalafi.behzad70@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-03-06, 1395/12/16
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
empty
Scientific title
The delayed umbilical cord clamping effects on early outcome in Preterm neonates
Public title
early outcome effects in delayed umbilical cord clamping
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant womens with preterm labor
Exclusion criteria:
Preeclampsia Diabetes Blood and coagulation Disorder Heart Disease Hb under 11 mg/dl Bleeding due to Premature separation of placenta more than one fetus
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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
Ethics committee of Kurdistan University of Medical Sciences
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.MUK.REC.1395/386

Health conditions studied

1

Description of health condition studied
prematurity
ICD-10 code
P07
ICD-10 code description
Disorders of newborn related to short gestation and low birth weight, not elsewhere classified

Primary outcomes

1

Description
Umbilical cord Clamping
Timepoint
180 and 30 second after birth
Method of measurement
chronometer

2

Description
weaning from the ventilator
Timepoint
Until discharge or death
Method of measurement
Review the case file

3

Description
discharge from ICU
Timepoint
Until discharge or death
Method of measurement
Review the case file

4

Description
Neonatal complications
Timepoint
during the hospitalization
Method of measurement
Physical examination and paraclinical evaluations and case review

5

Description
Need for surfactants
Timepoint
During the hospitalization
Method of measurement
Review the case file

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Babies born to mothers with gestational age of 28 to 36 weeks of gestation
Category
Treatment - Other

2

Description
Control group: Babies born to mothers with gestational age of 28 to 36 weeks of gestation
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Nooshafarin Naderi
Street address
Vakil Crossroad, Besat Hospital, Department of Obstetrics and Gynecology
City
Sanandaj
Province
Kurdistan
Postal code
000000000000
Phone
+98 87 3328 2004
Email
naderi.nooshafarin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Sanandaj, Kurdistan University of Medical Sciences, opposite Shadi Hotel, Kurdistan University of Medical Science, POB 6617713446 Management of medical research and information
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
khalafi.behzad70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Research Associate / Researcher Soldier - General Physician of Kurdistan University of Medical Scien
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences Vice Chancellor in Research Affair Pasdaran Ave. Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 45 3344 9697
Fax
+98 87 3366 4645
Email
khalafi.behzad70@muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Sholeh Shahgheibi
Position
Associate professor of Gny & Obs
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vakil Crossroad, Besat Hospital, Department of Obstetrics and Gynecology
City
sanandaj
Province
Kurdistan
Postal code
0000000000
Phone
+98 87 3328 2004
Email
shahgheibi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Behzad Khalafi
Position
Researcher assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
pasdaran Blvd, opposite Shadi Hotel, Kurdistan University of Medical Sciences, Sanandaj, Management of Medical Researches and Information. POB 6617713446
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3344 4645
Email
khalafi.behzad70@gmail.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Nooshafarin Naderi
What processes are involved for a request to access data/document
After submitting a request to the Kurdistan Research and Technology Dept. of Science and Technology, a call for submission is given.
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