The Effect of Umbilical Cord Care Training on Cord Falling Time

NCT ID: NCT05573737

Last Updated: 2023-07-12

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2023-05-15

Brief Summary

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

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.

Detailed Description

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

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.

Data Collection:

Stage 1: A pilot study will be conducted with 10 mothers in order to evaluate the appropriateness of the forms and scales used before the research.

Stage 2: The purpose of the research and how to record the data will be explained to the mothers. The mothers in the sample group will be informed about the path followed in practice and the research, and their verbal and written consent will be obtained.

Stage 3:The mothers who meet the sample selection criteria will be randomly and equally distributed into 2 groups through a program in the computer environment, and randomization will be provided.(http://www1.assumption.edu/users/avadum/applets/RandAssign/ GroupGen.html) (1st experimental education group, 2nd control group).

Stage 4: 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. Umbilical care training will be given to primiparous mothers who give birth on odd days of the week and meet the research criteria, and the training brochure will be printed out and given to 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.

The control group will be given routine clinic care. Stage 5: The time of fall of the umbilical cord will be recorded in the data collection form.

Stage 6:The analysis and reporting of the obtained data will be done.

Conditions

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

Umbilical Cord Issue Mothers Infant Conditions

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

NONE

Study Groups

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

Group Receiving Umbilical Cord Training

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.

Group Type EXPERIMENTAL

education

Intervention Type OTHER

education about ubilical cord care

Group Without Umbilical Cord Training

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.

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.

education

education about ubilical cord care

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

Firat University

OTHER

Sponsor Role lead

Responsible Party

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

Özlem Selime MERTER

ASSISTANT PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Atiye Karakul

Role: PRINCIPAL_INVESTIGATOR

Tarsus

Duygu Karaarslan

Role: PRINCIPAL_INVESTIGATOR

Manisa

Locations

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

Fırat University

Elâzığ, , Turkey (Türkiye)

Site Status

Fırat Univesity

Elâzığ, , 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.

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 27573092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27492278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28008096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34309309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30732206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28365249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31923218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29978816 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37202253 (View on PubMed)

Other Identifiers

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

2022/ 05- 35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Simulator Use in Newborn First Care
NCT06406738 COMPLETED NA