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The Effect of Umbilical Cord Clamping Distance

Primary Purpose

Newborn; Infection, Umbilical Cord Infection

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Umbilical cord clamping distance
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Newborn; Infection focused on measuring colonization, midwives, newborn, separation time, umbilical cord

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being at 38-42 weeks of gestation, being 18 years of age and over, having primary school education, being able to speak and understand Turkish, having no communication problems, not having a history of active or previous vaginal infection, living in the metropolitan area of Kahramanmaras, accepting home visits during the research process, and agreeing to participate in the research.

Exclusion Criteria:

  • Cesarean delivery, premature membrane rupture, newborns with severe congenital anomalies, severely ill infants requiring hospitalization immediately after birth, and babies born with a birth weight of less than 1500 g.

Sites / Locations

  • Adnan Menderes University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention group I

Intervention group II

Control group

Arm Description

In intervention group I - clamped at a distance of 2 cm - umbilical cord was measured 2 cm from the abdominal wall in the delivery room and clamped. This procedure was carried out by a single researcher using a 2 cm standard measuring tool (cut-to-size ruler) prepared before hand. In order to ensure standardization, this tool was cleaned with a disinfectant and used to measure the umbilical clamp distance of all newborns in the intervention group I.

In intervention group II - clamped at a distance of 3 cm - umbilical cord was measured 3 cm from the abdominal wall in the delivery room and clamped. This procedure was carried out by a single researcher using a 3 cm standard measuring tool (cut-to-size ruler) prepared before hand. In order to ensure standardization, this tool was cleaned with a disinfectant and used to measure the umbilical clamp distance of all newborns in the intervention group II.

Control group - clamped without measuring - no intervention was made in defining the distance at which the umbilical cord of the newborn would be clamped. Another healthcare workers measured the distance at which the umbilical cord had been clamped. The same researcher used a standard measuring tape to measure the distance between the umbilical cord to the clamping point.

Outcomes

Primary Outcome Measures

Umbilical cord separation time
assessed using the Umbilical Cord Follow-Up on Twentieth Day Form. This form consists of 17 questions prepared to investigate the umbilical cord separation time on the postpartum 20th day of the newborns in the intervention I, II, and control group. On the 20th day after birth, the mothers were called by mobile phone and information was obtained.
Umbilical cord microbial colonization
assessed with swab was taken from the umbilical cord on the 7th day. At home visits on the 7th postnatal day, a swab was taken from the umbilical cords of all newborns for microbial colonization. If the newborn's umbilical cord fell off on the 7th day postpartum visit, a swab was still taken. Umbilical swabs collected using transport swabs were transported to laboratory for culture. The result of the swab sample was taken 48 hours after the laboratory and it was determined whether there was colonization or not.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2021
Last Updated
April 26, 2021
Sponsor
Kahramanmaras Sutcu Imam University
Collaborators
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT04862403
Brief Title
The Effect of Umbilical Cord Clamping Distance
Official Title
The Effect of Umbilical Cord Clamping Distance on Cord Separation Time and Microbial Colonization: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University
Collaborators
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized control trial was conducted to test the effect of umbilical cord clamping distance on cord separation time and umbilical cord microbial colonization in neonates.
Detailed Description
Among the indicators of a country's level of development is the neonatal mortality rate. This rate reveals the extent of a country's economic development and how this affects health. One of the main causes of neonatal mortality is infection-related fatalities. Every year, approximately 700,000 neonatal deaths occur from bacterial infections.Navel cord infections comprise a large part of neonatal infections. The umbilical cord is clamped and cut off at a distance of 2-3 cm from the newborn's abdominal wall after birth, after which its function is terminated. The necrotic tissue remaining in the newborn's umbilical cord provides an ideal environment for bacterial growth. The umbilical cord dries out and falls in the interval between postpartum 5-15 day. The prolongation of the umbilical cord falling time increases the possibility of developing bacterial infection. The umbilical cord microbial colonization was usually detected on 5th and 7th days after birth. Since the time the umbilical cord falls off directly affects the health of the newborn, it is important to understand the factors that can affect this time. The literature reveals studies on umbilical cord separation times, most of which are devoted to comparing various techniques of caring for the cord. No study however has been discovered that has examined the effect of the distance between the abdominal wall of the newborn and the cord clamping site. It is believed that the clamping distance of the umbilical cord may be among the factors that have an impact on the separation time of the cord. Also, although midwives are responsible for the clamping and cutting of the umbilical cord, it is observed that there is no measuring instrument that is used in this procedure and the cord is clamped by eyeball estimation. There is no standard practice and there are also differences between the practices of midwives. This situation and the lack of adequate information in the literature on cord clamping distance pointed to the need for conducting a study in this context. This study was intended to determine the effect of umbilical cord clamping distance on the cord separation time and on microbial colonization in the umbilical cord. It was tested the hypotheses that there is no difference between the intervention and control groups of newborns after the umbilical cord clambing distance intervention, the cord separation time and on microbial colonization outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn; Infection, Umbilical Cord Infection
Keywords
colonization, midwives, newborn, separation time, umbilical cord

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group I
Arm Type
Experimental
Arm Description
In intervention group I - clamped at a distance of 2 cm - umbilical cord was measured 2 cm from the abdominal wall in the delivery room and clamped. This procedure was carried out by a single researcher using a 2 cm standard measuring tool (cut-to-size ruler) prepared before hand. In order to ensure standardization, this tool was cleaned with a disinfectant and used to measure the umbilical clamp distance of all newborns in the intervention group I.
Arm Title
Intervention group II
Arm Type
Experimental
Arm Description
In intervention group II - clamped at a distance of 3 cm - umbilical cord was measured 3 cm from the abdominal wall in the delivery room and clamped. This procedure was carried out by a single researcher using a 3 cm standard measuring tool (cut-to-size ruler) prepared before hand. In order to ensure standardization, this tool was cleaned with a disinfectant and used to measure the umbilical clamp distance of all newborns in the intervention group II.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group - clamped without measuring - no intervention was made in defining the distance at which the umbilical cord of the newborn would be clamped. Another healthcare workers measured the distance at which the umbilical cord had been clamped. The same researcher used a standard measuring tape to measure the distance between the umbilical cord to the clamping point.
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord clamping distance
Intervention Description
Intervention group I: Umbilical cord clamped at a distance of 2cm Intervention group II: Umbilical cord clamped at a distance of 3cm Control group: Usual care (clamped without measurement).
Primary Outcome Measure Information:
Title
Umbilical cord separation time
Description
assessed using the Umbilical Cord Follow-Up on Twentieth Day Form. This form consists of 17 questions prepared to investigate the umbilical cord separation time on the postpartum 20th day of the newborns in the intervention I, II, and control group. On the 20th day after birth, the mothers were called by mobile phone and information was obtained.
Time Frame
20th day after the birth
Title
Umbilical cord microbial colonization
Description
assessed with swab was taken from the umbilical cord on the 7th day. At home visits on the 7th postnatal day, a swab was taken from the umbilical cords of all newborns for microbial colonization. If the newborn's umbilical cord fell off on the 7th day postpartum visit, a swab was still taken. Umbilical swabs collected using transport swabs were transported to laboratory for culture. The result of the swab sample was taken 48 hours after the laboratory and it was determined whether there was colonization or not.
Time Frame
7th day after the birth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being at 38-42 weeks of gestation, being 18 years of age and over, having primary school education, being able to speak and understand Turkish, having no communication problems, not having a history of active or previous vaginal infection, living in the metropolitan area of Kahramanmaras, accepting home visits during the research process, and agreeing to participate in the research. Exclusion Criteria: Cesarean delivery, premature membrane rupture, newborns with severe congenital anomalies, severely ill infants requiring hospitalization immediately after birth, and babies born with a birth weight of less than 1500 g.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Akyıldız, PhD
Organizational Affiliation
Kahramanmaras Sutcu Imam University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayden Çoban, Prof.
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Adnan Menderes University
City
Aydın
ZIP/Postal Code
0900
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24853593
Citation
Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19. Erratum In: Lancet. 2014 Jul 12;384(9938):132.
Results Reference
background
PubMed Identifier
27573092
Citation
Stewart D, Benitz W; COMMITTEE ON FETUS AND NEWBORN. Umbilical Cord Care in the Newborn Infant. Pediatrics. 2016 Sep;138(3):e20162149. doi: 10.1542/peds.2016-2149.
Results Reference
background
Citation
Duchowska A, Azsukowski P. Remarks on the length of umbilical arteries inhuman umbilical cord. A preliminary report. Archives of Perinatal Medicine. 2012;18(3):169-172.
Results Reference
background
PubMed Identifier
21094416
Citation
Ganatra HA, Zaidi AK. Neonatal infections in the developing world. Semin Perinatol. 2010 Dec;34(6):416-25. doi: 10.1053/j.semperi.2010.09.004.
Results Reference
background
PubMed Identifier
23076382
Citation
Karumbi J, Mulaku M, Aluvaala J, English M, Opiyo N. Topical umbilical cord care for prevention of infection and neonatal mortality. Pediatr Infect Dis J. 2013 Jan;32(1):78-83. doi: 10.1097/INF.0b013e3182783dc3.
Results Reference
background
PubMed Identifier
22322124
Citation
Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
Results Reference
background
PubMed Identifier
27022383
Citation
Abbaszadeh F, Hajizadeh Z, Jahangiri M. Comparing the Impact of Topical Application of Human Milk and Chlorhexidine on Cord Separation Time in Newborns. Pak J Med Sci. 2016 Jan-Feb;32(1):239-43. doi: 10.12669/pjms.321.8223.
Results Reference
background

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The Effect of Umbilical Cord Clamping Distance

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