Newborn; InfectionNCT04862403
The Effect of Umbilical Cord Clamping Distance
A study testing Umbilical cord clamping distance in people with Newborn; Infection and Umbilical Cord Infection, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborn; Infection, Umbilical Cord Infection
- What is being tested?
- Umbilical cord clamping distance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 30 Mar 2019
- 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 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Umbilical Cord Clamping Distance on Cord Separation Time and Microbial Colonization: Randomized Controlled Study
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.
Read the detailed description
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
- Newborn; Infection, Umbilical Cord Infection
- Being tested
- Umbilical cord clamping distance
- Keywords
- colonization, midwives, newborn, separation time, umbilical cord
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord clamping distanceProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7th day after the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Jun 2018
- Primary completion1 Jun 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Newborn; InfectionStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Responsible party
- Principal investigator, Deniz Akyıldız, Kahramanmaras Sutcu Imam University
- Investigators
- Deniz Akyıldız, PhD, Principal investigator, Kahramanmaras Sutcu Imam UniversityAyden Çoban, Prof., Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862403
- Sponsor's protocol ID
- Cord Clamping Distance
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24853593Stewart 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 27573092Duchowska 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.
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.
PubMed 21094416Karumbi 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.
PubMed 23076382Arifeen 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.
PubMed 22322124Abbaszadeh 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.
PubMed 27022383Akyildiz 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.
PubMed 36941099
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Umbilical Cord Clamping Distance on Cord Separation Time and Microbial Colonization: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04862403
- Acronym / sponsor ID
- Cord Clamping Distance
- Conditions
- Newborn; Infection, Umbilical Cord Infection
- Keywords
- colonization, midwives, newborn, separation time, umbilical cord
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 28 Apr 2021 (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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group I | Experimental | Procedure: Umbilical cord clamping distanceIn 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. |
| Intervention group II | Experimental | Procedure: Umbilical cord clamping distanceIn 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. |
| 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. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Umbilical cord clamping distanceIntervention 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). | Procedure or surgery | Intervention group I, Intervention group II |
Primary outcome
Umbilical cord separation time
Time frame: 20th day after the birth
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.
Umbilical cord microbial colonization
Time frame: 7th day after the birth
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.
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 28 Apr 2021.
- Background: PubMed 24853593Lawn 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.
- 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.
- BackgroundDuchowska 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: PubMed 21094416Ganatra 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.
- Background: PubMed 23076382Karumbi 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.
- Background: PubMed 22322124Arifeen 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.
- Background: PubMed 27022383Abbaszadeh 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.
- Derived from this study: PubMed 36941099Akyildiz 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.
- Individual participant dataSharing planned: No
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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.
Deniz Akyıldız, PhD principal investigator
Kahramanmaras Sutcu Imam University
Ayden Çoban, Prof. study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord clamping distance in people with Newborn; Infection and Umbilical Cord Infection, run by Kahramanmaras Sutcu Imam University at 1 site 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 1 inclusion and 1 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Umbilical cord separation time (time frame: 20th day after the birth). The study lists 2 primary outcomes in all. 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 NCT04862403, which also lists 8 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 28 Apr 2021.