NCT05573737

Brief Summary

Under normal conditions, the umbilical cord is removed 5-15 days after birth. It dries up and falls within days. It is extremely important to determine the factors that cause the prolongation of the falling time of the cord, which poses a serious risk for infection. The aim of this study is to determine the effect of umbilical cord care training given to primiparous mothers on the duration of cord fall. It is a randomized controlled type of research. The population of the research will be primiparous mothers who gave birth in the obstetrics clinic of a university hospital. A pilot study will be conducted to determine the number of samples. As a result of the pilot study, power analysis will be performed and the number of samples will be determined. Inclusion criteria of mothers in the study; Data collection tools: "Descriptive Questionnaire" and "Questionnaire for Umbilical Cord Care" will be used to collect research data. Randomization will be done as odd days of the week and even days of the week for sample selection in the study. Primiparous mothers giving birth on odd days of the week will form the group that will receive umbilical cord training, while primiparous mothers giving birth on even days of the week will form the group that does not receive training. The research will be carried out in two stages. In the first stage of the research, after informing the mothers about the study, they will be invited to the research. Written consent will be obtained from mothers who volunteered to participate in the study. Then, the "Descriptive Questionnaire" prepared to describe mothers and babies will be filled. In the second stage of the research: the mothers will be called 15-20 days after the first interview and the "Question Form Regarding Umbilical Cord Care" will be filled.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

October 6, 2022

Last Update Submit

July 11, 2023

Conditions

Keywords

infantmothers educationumbilical cord

Outcome Measures

Primary Outcomes (1)

  • QUESTION FORM FOR UMBLIKAL CORD CARE

    It was prepared by researchers in line with the literature in order to evaluate the umbilical cord and care of the baby and to investigate the umbilical fall time. Expert opinion will be taken for the suitability of the form. There are no minimum and maximum scores in the prepared form. The questionnaire are: 1. Has your baby's umbilical cord fallen off? 2. Did you close the umbilical cord? 3- Did you bathe your baby before the umbilical cord fell off? 4- If you gave your baby a bath, how did you do it? 5- Have you used any product (alcohol, tenderdiode, ointment, powder, etc.) for your baby's belly care? 6- When tying your baby's diaper, did you pay attention to keep the umbilical cord outside? 7- Has the umbilical cord been in contact with urine or stool? 8- What type of diaper do you use for your baby? 9- Have you had any traditional practices regarding your baby's navel care? 10- What is the baby's diet?

    1 day

Study Arms (2)

Group Receiving Umbilical Cord Training

EXPERIMENTAL

Oral umbilical care training will be given to the primiparous mothers who gave birth on odd days of the week and met the research criteria, and the training brochure will be printed out and given to the mothers. The training will be given face-to-face during the postpartum period when the mother is stabilized. In order to increase the effectiveness of the training, the content of the training will be reinforced by making mutual questions and answers.

Other: education

Group Without Umbilical Cord Training

NO INTERVENTION

The routine operation of the clinic will be carried out without any intervention for primiparous mothers who gave birth on even days of the week and met the research criteria.

Interventions

education about ubilical cord care

Group Receiving Umbilical Cord Training

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knowing the last menstrual period (SAT),
  • Gestational week (GH) interval is due (38-42 GH)
  • Able to speak and understand Turkish,
  • Not having any chronic disease (diabetes, hypertension, hyper/hypotroid etc.),
  • Over 18 years old,
  • Normal vaginal delivery
  • First born

You may not qualify if:

  • Umbilical cord anomaly (long cord, cord entanglement etc.),
  • Needing resuscitation or having a fifth-minute APGAR score of less than 7,
  • Birth weight below 2500 g,
  • Rh, ABO incompatibility
  • Newborns whose umbilical cord does not fall on the postpartum 20th day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fırat University

Elâzığ, Turkey (Türkiye)

Location

Fırat Univesity

Elâzığ, Turkey (Türkiye)

Location

Related Publications (11)

  • Lyngdoh, D., Kaur, S., Kumar, P., Gautam, V., & Ghai, S.(2018). Effect of topical application of human breast milk versus 4% chlorhexidine versus dry cord care on bacterial colonization and clinical outcomes of umbilical cord in preterm newborns. Journal of Clinical Neonatology, 7(1), 25.

    BACKGROUND
  • Oladokun, R. E., Orimadegun, A.E., & Olowu, J. A. (2005). Umbilical Cord Separation Time in Healthy Nigerian Newborns Niger. J Paediatr, 32(1), 19-25.

    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: 27573092BACKGROUND
  • Nosan G, Paro-Panjan D. Umbilical cord care: national survey, literature review and recommendations. J Matern Fetal Neonatal Med. 2017 Jul;30(14):1655-1658. doi: 10.1080/14767058.2016.1220530. Epub 2016 Aug 23.

    PMID: 27492278BACKGROUND
  • Gras-Le Guen C, Caille A, Launay E, Boscher C, Godon N, Savagner C, Descombes E, Gremmo-Feger G, Pladys P, Saillant D, Legrand A, Caillon J, Barbarot S, Roze JC, Giraudeau B. Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial. Pediatrics. 2017 Jan;139(1):e20161857. doi: 10.1542/peds.2016-1857.

    PMID: 28008096BACKGROUND
  • Ceriani Cernadas JM. Umbilical cord clamping in preterm infants. Arch Argent Pediatr. 2021 Aug;119(4):e315-e321. doi: 10.5546/aap.2021.eng.e315. English, Spanish.

    PMID: 34309309BACKGROUND
  • Shang Y, Sun Y. Comparison of the effectiveness of different umbilical cord care in infants: A protocol for systematic review and network meta-analysis. Medicine (Baltimore). 2019 Feb;98(6):e14440. doi: 10.1097/MD.0000000000014440.

    PMID: 30732206BACKGROUND
  • Uysal G, Sonmez Duzkaya D. Umbilical Cord Care and Infection Rates in Turkey. J Obstet Gynecol Neonatal Nurs. 2017 May-Jun;46(3):e118-e124. doi: 10.1016/j.jogn.2017.01.008. Epub 2017 Mar 29.

    PMID: 28365249BACKGROUND
  • Lopez-Medina MD, Lopez-Araque AB, Linares-Abad M, Lopez-Medina IM. Umbilical cord separation time, predictors and healing complications in newborns with dry care. PLoS One. 2020 Jan 10;15(1):e0227209. doi: 10.1371/journal.pone.0227209. eCollection 2020.

    PMID: 31923218BACKGROUND
  • Sachdeva A, Gunasekaran V, Malhotra P, Bhurani D, Yadav SP, Radhakrishnan N, Kalra M, Bhat S, Misra R, Jog P; 'Guidelines on Umbilical Cord Blood Banking' Committee of Indian Academy of Pediatrics. Umbilical Cord Blood Banking: Consensus Statement of the Indian Academy of Pediatrics. Indian Pediatr. 2018 Jun 15;55(6):489-494.

    PMID: 29978816BACKGROUND
  • Merter OS, Karakul A, Karaarslan D, Assistant R. The impact of umbilical cord care education given to Primiparous mothers on cord separation time: A randomized controlled study. J Pediatr Nurs. 2023 Jul-Aug;71:e128-e134. doi: 10.1016/j.pedn.2023.05.005. Epub 2023 May 16.

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Atiye Karakul

    Tarsus

    PRINCIPAL INVESTIGATOR
  • Duygu Karaarslan

    Manisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

December 30, 2022

Primary Completion

February 28, 2023

Study Completion

May 15, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations