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The effect of umbilical cord milking on neonatal outcome in preterm infants

Protocol summary

Summary
The objective of this interventional study is to compare the neonatal outcomes between the infants with milked umbilical cord and infants without it, 80 pregnant women with a gestational age of 28-34 weeks who were admitted for normal delivery or cesarean section at Shariati Hospital of Bandar Abbas and they lacked the exclusion criteria (Cord less than 25 cm; Vigorous or Meconiumstain; Motility, ABO or Rh negative mother; Congenital major anomalies; Umbilical cord prolapse; Phytoplasmic hydrops; Placenta; Placental decompression; true umbilical knot and maternal diseases such as maternal diabetes mellitus; maternal hypertension) were randomly divided into two groups. In group 1, after delivery by natural delivery the baby is positioned at the uterus and in delivery by cesarean section along the thigh. Immediately the umbilical cord will be disconnected 25 cm from the navel surface and placed under the Warmer, then the umbilical cord Raised and taken three times at the cut off end at the speed of 10 cm / s to the baby's side, and will eventually be cut from the distance of 2 cm above the navel get clamped and will be cut off. In group 2, after delivery by natural delivery the baby is positioned at the uterus and in delivery by cesarean section along the thigh and the cord is cut off without dipping. It is then compared for neonatal outcomes including birth hemoglobin and hematocrit, Neonatal hypertension, respiratory distress, jaundice requiring phototherapy, IVH, Hypercalcemia, and volume of injected blood.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072031697N1
Registration date: 2017-08-27, 1396/06/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-27, 1396/06/05
Registrant information
Name
Afshin Parvizpanah
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 6625
Email address
afshin.parvizpanah@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of umbilical cord milking on neonatal outcome in preterm infants
Public title
The effect of umbilical cord milking on neonatal outcome in preterm infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All pregnant women 28 to 34 weeks of gestation (based on the first trimester ultrasonography of pregnancy). Exclusion criteria: Short cord (less than 25 cm); Vigorous or meconium stained; congenital major anomalies; Umbilical cord prolapse; Phytoplasmic hydrops; multiple pulmonary deliveries; maternal ABO or negative Rh mother; mothers with placenta and decollete pair; mothers Abnormal umbilical cord such as a true knot; mothers with underlying illnesses; Such as diabetes and high blood pressure; Not being a resident of Hormozgan or lack of follow-up.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hoemozgan University of Medical Sciences
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
HUMS.REC.1394.009

Health conditions studied

1

Description of health condition studied
Preterm infant
ICD-10 code
P07.30
ICD-10 code description
Preterm newborn, unspecified weeks of gestation

Primary outcomes

1

Description
Hemoglobin premature infants
Timepoint
48 hours after birth
Method of measurement
According to the results reported by the laboratory of Shariati Hospital and expressed in grams per liter of blood.

Secondary outcomes

1

Description
Intrauterine pulmonary edema
Timepoint
After birth
Method of measurement
Intravenous hemorrhage of the baby, expressed on the basis of sonography.

2

Description
Infant hematocrit
Timepoint
48 hours after birth
Method of measurement
Based on the results reported by Shariati Hospital's laboratory, it is expressed in terms of percentage and number.

3

Description
Primary neonatal hypertension
Timepoint
After birth
Method of measurement
Based on the report reported by Shariati Hospital's laboratory based on mmHg and with the number.

Intervention groups

1

Description
In case group, after delivery by natural delivery the baby is positioned at the uterus and in delivery by cesarean section along the thigh. Immediately the umbilical cord will be disconnected 25 cm from the navel. The baby will be placed underneath the warmer and the umbilical cord was raised, 3 times from the cut off end at the speed of 10 centimeters per second toward the infant, and finally, 2 cm above the navel, the umbilical cord is clamped and cut off.
Category
Treatment - Surgery

2

Description
In the control group, after delivery by natural delivery the baby is positioned at the uterus and in delivery by cesarean section along the thigh. Immediately the umbilical cord will be disconnected 25 cm from the navel surface and placed under the Warmer, and the umbilical cord is removed from the spacing 2 cm above the navel, get clamped and will cut off.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hoemozgan University of Medical Sciences
Full name of responsible person
Teamour Aghamolai
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hoemozgan 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
Hoemozgan University of Medical Sciences
Full name of responsible person
Parvaneh Heidari
Position
Gynecologist
Other areas of specialty/work
Street address
Khalij-e-Fars Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 3333 6625
Fax
Email
afshinpgp@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hoemozgan University of Medical Sciences
Full name of responsible person
Parvaneh Heidari
Position
Gynecologist
Other areas of specialty/work
Street address
Khalij-e-Fars Hospital
City
Bandar Abbas
Postal code
Phone
+98 76 3333 6625
Fax
Email
afshinpgp@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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