Clinical trial NCT04862403: 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
Overall status: COMPLETED
Phase: NA
Conditions: Newborn; Infection
Umbilical Cord Infection
Keywords: colonization
midwives
newborn
separation time
umbilical cord
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
Collaborators: name: Aydin Adnan Menderes University
First posted: 2021-04-28
Enrollment: 108
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Umbilical cord separation time
timeFrame: 20th day after the birth
measure: Umbilical cord microbial colonization
timeFrame: 7th day after the birth
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Deniz Akyıldız, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aydin Adnan Menderes University
name: Ayden Çoban, Prof.
role: STUDY_DIRECTOR
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