The Effect of Umbilical Cord Clamping Distance

Newborn; Infection Clinical Trial

Official title:

The Effect of Umbilical Cord Clamping Distance on Cord Separation Time and Microbial Colonization: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04862403
• Other study ID #: Cord Clamping Distance
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2021
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 30, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Weeks to 42 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Newborn; Infection

Intervention

Procedure:
• Umbilical cord clamping distance
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).

Locations

Country	Name	City	State
Turkey	Adnan Menderes University	Aydin

Sponsors (2)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University	Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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. — View 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.

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. Review. — View 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. Review. — View 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. Review. Erratum in: Lancet. 2014 Jul 12;384(9938):132. — View Citation

Stewart D, Benitz W; COMMITTEE ON FETUS AND NEWBORN. Umbilical Cord Care in the Newborn Infant. Pediatrics. 2016 Sep;138(3). pii: e20162149. doi: 10.1542/peds.2016-2149. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20th day after the birth
Primary	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.	7th day after the birth