Umbilical Cord IssueNCT05573737
The Effect of Umbilical Cord Care Training on Cord Falling Time
A study testing education in people with Umbilical Cord Issue and Mothers, run by Firat University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Issue, Mothers, Infant Conditions
- What is being tested?
- education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fırat University
Elâzığ
Fırat Univesity
Elâzığ
About this study
Official title: Investigation of the Effect of Umbilical Cord Care Training Given to Primiparous Mothers on Cord Duration: A Randomized Controlled Study
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.
Read the detailed description
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
- Umbilical Cord Issue, Mothers, Infant Conditions
- Being tested
- education
- Keywords
- infant, mothers education, umbilical cord
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
education about ubilical cord care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Has your baby's umbilical cord fallen off?
- 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?
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start30 Dec 2022
- Primary completion28 Feb 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Selime MERTER, Firat University
- Investigators
- Atiye Karakul, Principal investigator, TarsusDuygu Karaarslan, Principal investigator, Manisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573737
- Sponsor's protocol ID
- 2022/ 05- 35
- Status last verified
- Jul 2023
- First submitted
- 6 Oct 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
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.
PubMed 27573092Nosan 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.
PubMed 27492278Gras-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.
PubMed 28008096Ceriani 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.
PubMed 34309309Shang 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.
PubMed 30732206Uysal 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.
PubMed 28365249Lopez-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.
PubMed 31923218Sachdeva 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.
PubMed 29978816Merter 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.
PubMed 37202253
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Umbilical Cord Care Training Given to Primiparous Mothers on Cord Duration: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05573737
- Acronym / sponsor ID
- 2022/ 05- 35
- Conditions
- Umbilical Cord Issue, Mothers, Infant Conditions
- Keywords
- infant, mothers education, umbilical cord
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Receiving Umbilical Cord Training | Experimental | Other: educationOral 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationeducation about ubilical cord care | Other | Group Receiving Umbilical Cord Training |
Primary outcome
QUESTION FORM FOR UMBLIKAL CORD CARE
Time frame: 1 day
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- BackgroundLyngdoh, 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.
- BackgroundOladokun, 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: PubMed 27573092Stewart 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.
- Background: PubMed 27492278Nosan 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.
- Background: PubMed 28008096Gras-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.
- Background: PubMed 34309309Ceriani 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.
- Background: PubMed 30732206Shang 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.
- Background: PubMed 28365249Uysal 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.
- Background: PubMed 31923218Lopez-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.
- Background: PubMed 29978816Sachdeva 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.
- Derived from this study: PubMed 37202253Merter 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atiye Karakul principal investigator
Tarsus
Duygu Karaarslan principal investigator
Manisa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Umbilical Cord Issue and Mothers, run by Firat University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUESTION FORM FOR UMBLIKAL CORD CARE (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05573737, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.