The Effect of Umbilical Cord Clamping Distance

NCT ID: NCT04862403

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn; Infection Umbilical Cord Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group I

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.

Group Type EXPERIMENTAL

Umbilical cord clamping distance

Intervention Type 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 II

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.

Group Type EXPERIMENTAL

Umbilical cord clamping distance

Intervention Type 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).

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

37 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aydin Adnan Menderes University

OTHER

Sponsor Role collaborator

Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deniz Akyıldız

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deniz Akyıldız, PhD

Role: PRINCIPAL_INVESTIGATOR

Kahramanmaras Sutcu Imam University

Ayden Çoban, Prof.

Role: STUDY_DIRECTOR

Aydin Adnan Menderes University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adnan Menderes University

Aydin, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24853593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27573092 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 21094416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23076382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22322124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27022383 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36941099 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cord Clamping Distance

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.