18 Years and OverDCC&MILKHEM PNCT06865391
Multıdımensıonal Effects Of Delayed Cord Clampıng and Mılkıng on Placental Processes
A study testing Delayed cord clamping in people with 18 Years and Over and Newborn Health, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effects of delayed cord clamping and milking the umbilical cord of term babies after 90 seconds during vaginal birth on the newborn and the mother and to determine whether it is a suitable alternative method for cord management after birth. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 18 Years and Over, Newborn Health, 37 or More Completed Weeks of Gestation
- What is being tested?
- Delayed cord clamping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2025to 30 Apr 2025
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being 18 years of age and older,
- having a single healthy newborn,
- having a 37-42 week pregnancy,
- having a baby in cephalic presentation, and
- having a first birth (nulliparous).
Who cannot join
- women with gestational anemia,
- having abnormal placentation (such as bleeding, hypertension),
- having a maternal hemorrhage,
- having Rh isoimmunization, and
- having a baby with a major congenital malformation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmama Universty
Kahramanmaraş Merkez, K.maraş, 461000
About this study
Official title: Multıdımensıonal Effects Of Delayed Cord Clampıng and Mılkıng on Placental Processes and Maternal-Newborn Hematologıcal Parameters ın Postpartum Cord Management
This study was conducted to evaluate the effects of delayed cord clamping and milking the umbilical cord of term babies after 90 seconds during vaginal birth on the newborn and the mother and to determine whether it is a suitable alternative method for cord management after birth.
Methods: The study was conducted in the form of a randomized controlled design. The study was conducted in a hospital in eastern Turkiye between February -January 2025. The study was completed with 108 women who had vaginal delivery at term (DCC group n=36, UCM group n=36, control group n=36). Participants were assigned to groups by simple randomization. Data collection tools were used to collect demographic information, maternal hemoglobin, and hematocrit values, placental abruption time, newborn APGAR scores, umbilical cord pH levels, and day 7 hematological/biochemical parameters.
Read the detailed description
Labor and the postpartum period are critical periods that can have long-term effects on both maternal and neonatal health. Evidence-based interventions implemented during this period play a significant role in maternal physiological recovery, placental abruption, neonatal health parameters, and long-term health bilical cord management (delayed cord clamping [DCC] and umbilical cord milking [UCM]) has become an important research topic in recent years regarding its effects on maternal and neonatal outcomes DCC is defined by clamping the umbilical cord after birth for a certain period of time, and it has been shown that this practice can increase neonatal hemoglobin and hematocrit levels and reduce the risk of neonatal anemia . At the same time, it has been reported that DCC is especially recommended to reduce iron deficiency anemia in low-income countries . However, there are also views that DCC may prolong the time to placental abruption and increase the risk of postpartum hemorrhage in the mother UCM is defined as the process of pushing blood in the umbilical cord to the newborn with mechanical movement. There are studies indicating that this method improves oxygen transport by increasing blood volume and reduces the risk of intraventricular hemorrhage while increasing cardiovascular stability in premature babiesHowever, there are conflicting results in the literature regarding the effects of this method on hyperbilirubinemia and hemoglobin increase The effects of these different methods in umbilical cord management on maternal hemoglobin and hematocrit levels, placental abruption time, neonatal hematological and biochemical parameters, and postpartum complications have been an important area of research . Studies have emphasized that there are important relationships between the duration of placental abruption and neonatal health indicators and that these processes should be examined in detail . It has been reported that providing additional blood volume, especially in premature babies, can improve neonatological parameters and have important effects on maternal health . Therefore, studies have emphasized that the relationships between the duration of placental abruption and the timing of separation signs and neonatal health indicators should be examined in detail .In this study, many outcomes such as placental abruption time, maternal hemoglobin and hematocrit levels, and neonatal hematological and biochemical parameters were evaluated in this context. Therefore, this study aims to provide evidence to make a significant contribution to the literature on umbilical cord management practices and to determine the place of these practices in clinical practice.
- Being tested
- Delayed cord clamping
- Keywords
- delayed cord clamping, cord milking, placenta, clinical outcome, midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Delayed cord clamping (DCC) was defined as clamping the umbilical cord 90 seconds after birth. A stopwatch was used to record the time of all interventions and was noted in the study protocol.
Umbilical Cord Milking (UCM) is the process of grasping the umbilical cord towards the newborn before cutting the umbilical cord and pushing the blood towards the newborn 3-4 times within 20 seconds." In this group, early cord clamping (<30 seconds) was performed after birth from 25-30 cm ahead of the newborn for a total of 4 times. UCM, with one hand, the cord was pinched and held closest to the placental end, the other hand was used to milk blood towards the infant where at the umbilical endpoint the cord was held. This served as one milking motion. The cord was then released at the placental end and allowed to refill over 1 to 2 seconds between each milking motion. This was repeated a total of 4 times. After milking, the cord was clamped and cut, and the neonate was handed over to Receives: Behavioral: Delayed cord clamping |
| control group | No intervention | standart care grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
APGAR
APGAR scores,Developed in 1953 by Dr Virginia Apgar for the quantitative assessment of the vitality of the newborn, the scoring system is used in almost all neonatal units as an easy and rapid method to determine the condition of the child at birth. Its aim is to encourage closer observation and to provide a more precise assessment of the clinical status of infants. According to the Apgar scoring system, the newborn is assessed at 1 and 5 minutes after birth and if necessary, the scoring is repeated every 5 minutes. Apgar scoring is based on 5 objective parameters: 1. peak heart rate, 2. respiratory pattern, 3. muscle tone, 4. skin colour, 5. response to stimulation. Each parameter is given 0, 1 and 2 points. The scores given for each parameter are summed. Values between 710 points are considered healthy newborns, while 4-6 points are considered moderate depression and 0-3 points are considered severe depression.
Measured: 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 Mar 2025
- Primary completion28 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18 Years and OverStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865391
- Sponsor's protocol ID
- KahramanmaraşSIUI5
- Acronym
- DCC&MILKHEM P
- Status last verified
- Aug 2025
- First submitted
- 14 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multıdımensıonal Effects Of Delayed Cord Clampıng and Mılkıng on Placental Processes and Maternal-Newborn Hematologıcal Parameters ın Postpartum Cord Management
- ClinicalTrials.gov ID
- NCT06865391
- Acronym / sponsor ID
- DCC&MILKHEM P / KahramanmaraşSIUI5
- Keywords
- delayed cord clamping, cord milking, placenta, clinical outcome, midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Mar 2025 (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.
This study was conducted to evaluate the effects of delayed cord clamping and milking the umbilical cord of term babies after 90 seconds during vaginal birth on the newborn and the mother and to determine whether it is a suitable alternative method for cord management after birth.
Methods: The study was conducted in the form of a randomized controlled design. The study was conducted in a hospital in eastern Turkiye between February -January 2025. The study was completed with 108 women who had vaginal delivery at term (DCC group n=36, UCM group n=36, control group n=36). Participants were assigned to groups by simple randomization. Data collection tools were used to collect demographic information, maternal hemoglobin, and hematocrit values, placental abruption time, newborn APGAR scores, umbilical cord pH levels, and day 7 hematological/biochemical parameters.
Detailed description
Labor and the postpartum period are critical periods that can have long-term effects on both maternal and neonatal health. Evidence-based interventions implemented during this period play a significant role in maternal physiological recovery, placental abruption, neonatal health parameters, and long-term health bilical cord management (delayed cord clamping [DCC] and umbilical cord milking [UCM]) has become an important research topic in recent years regarding its effects on maternal and neonatal outcomes DCC is defined by clamping the umbilical cord after birth for a certain period of time, and it has been shown that this practice can increase neonatal hemoglobin and hematocrit levels and reduce the risk of neonatal anemia . At the same time, it has been reported that DCC is especially recommended to reduce iron deficiency anemia in low-income countries . However, there are also views that DCC may prolong the time to placental abruption and increase the risk of postpartum hemorrhage in the mother UCM is defined as the process of pushing blood in the umbilical cord to the newborn with mechanical movement. There are studies indicating that this method improves oxygen transport by increasing blood volume and reduces the risk of intraventricular hemorrhage while increasing cardiovascular stability in premature babiesHowever, there are conflicting results in the literature regarding the effects of this method on hyperbilirubinemia and hemoglobin increase The effects of these different methods in umbilical cord management on maternal hemoglobin and hematocrit levels, placental abruption time, neonatal hematological and biochemical parameters, and postpartum complications have been an important area of research . Studies have emphasized that there are important relationships between the duration of placental abruption and neonatal health indicators and that these processes should be examined in detail . It has been reported that providing additional blood volume, especially in premature babies, can improve neonatological parameters and have important effects on maternal health . Therefore, studies have emphasized that the relationships between the duration of placental abruption and the timing of separation signs and neonatal health indicators should be examined in detail .In this study, many outcomes such as placental abruption time, maternal hemoglobin and hematocrit levels, and neonatal hematological and biochemical parameters were evaluated in this context. Therefore, this study aims to provide evidence to make a significant contribution to the literature on umbilical cord management practices and to determine the place of these practices in clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Delayed cord clampingDelayed cord clamping (DCC) was defined as clamping the umbilical cord 90 seconds after birth. A stopwatch was used to record the time of all interventions and was noted in the study protocol. Umbilical Cord Milking (UCM) is the process of grasping the umbilical cord towards the newborn before cutting the umbilical cord and pushing the blood towards the newborn 3-4 times within 20 seconds." In this group, early cord clamping (<30 seconds) was performed after birth from 25-30 cm ahead of the newborn for a total of 4 times. UCM, with one hand, the cord was pinched and held closest to the placental end, the other hand was used to milk blood towards the infant where at the umbilical endpoint the cord was held. This served as one milking motion. The cord was then released at the placental end and allowed to refill over 1 to 2 seconds between each milking motion. This was repeated a total of 4 times. After milking, the cord was clamped and cut, and the neonate was handed over to |
| control group | No intervention | –standart care grup |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- being 18 years of age and older,
- having a single healthy newborn,
- having a 37-42 week pregnancy,
- having a baby in cephalic presentation, and
- having a first birth (nulliparous).
Key exclusion criteria (5 listed)
- women with gestational anemia,
- having abnormal placentation (such as bleeding, hypertension),
- having a maternal hemorrhage,
- having Rh isoimmunization, and
- having a baby with a major congenital malformation
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 |
|---|---|---|
| Delayed cord clamping | Behavioural | Experimental |
Primary outcome
APGAR
Time frame: 5 minutes after birth
APGAR scores,Developed in 1953 by Dr Virginia Apgar for the quantitative assessment of the vitality of the newborn, the scoring system is used in almost all neonatal units as an easy and rapid method to determine the condition of the child at birth. Its aim is to encourage closer observation and to provide a more precise assessment of the clinical status of infants. According to the Apgar scoring system, the newborn is assessed at 1 and 5 minutes after birth and if necessary, the scoring is repeated every 5 minutes. Apgar scoring is based on 5 objective parameters: 1. peak heart rate, 2. respiratory pattern, 3. muscle tone, 4. skin colour, 5. response to stimulation. Each parameter is given 0, 1 and 2 points. The scores given for each parameter are summed. Values between 710 points are considered healthy newborns, while 4-6 points are considered moderate depression and 0-3 points are considered severe depression.
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 14 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping in people with 18 Years and Over and Newborn Health, 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 5 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 14 Aug 2025. 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?
APGAR (time frame: 5 minutes after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.