The Effect of Umbilical Cord Clamping Distance

NCT04862403 | Completed

• 1 other identifier: Cord Clamping Distance
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn; Infection; Umbilical Cord Infection

Keywords

colonization; midwives; newborn; separation time; umbilical cord

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Intervention group I

EXPERIMENTAL

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.

Procedure: Umbilical cord clamping distance

Intervention group II

EXPERIMENTAL

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.

Procedure: Umbilical cord clamping distance

Control group

NO INTERVENTION

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.

Interventions

Umbilical cord clamping distance PROCEDURE

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).

Intervention group I; Intervention group II

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead
• Aydin Adnan Menderes University: collaborator

Study Sites (1)

Adnan Menderes University

Aydin, 0900, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 24853593 BACKGROUND

• 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.

  PMID: 27573092 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21094416 BACKGROUND

• 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.

  PMID: 23076382 BACKGROUND

• 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.

  PMID: 22322124 BACKGROUND

• 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.

  PMID: 27022383 BACKGROUND

• Akyildiz D, Coban A. How the Clamping Distance of the Umbilical Cord affects Microbial Colonization and Cord Separation Time: A Randomized Trial. P R Health Sci J. 2023 Mar;42(1):50-56.

  PMID: 36941099 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Deniz Akyıldız, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• Ayden Çoban, Prof.

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 28, 2021
• Study Start: June 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: March 30, 2019
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)