Effects of a Cord Clamping Bundle on Maternal and Neonatal OutcomesCord ClampingNCT07701434
"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"
A study testing Cord Clamping Bundle and Routine Cord Clamping Care in people with Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes, run by Elif MARANGOZ.
Trial summary
This clinical trial aims to evaluate the effects of a cord clamping bundle developed through the Delphi method on maternal and neonatal outcomes. The study population consists of primiparous women with singleton term pregnancies (37-42 weeks of gestation) who undergo vaginal delivery, along with their healthy… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes
- What is being tested?
- Cord Clamping Bundle and Routine Cord Clamping Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women Singleton pregnancy Term pregnancy (37-42 weeks of gestation) Vaginal delivery Healthy newborn Mother and newborn discharged together Age 18 years or older Willingness to participate and provide written informed consent
Who cannot join
- High-risk pregnancy Maternal chronic disease Maternal or neonatal conditions affecting breastfeeding Newborn with intrauterine growth restriction (IUGR) Newborn with a genetic disorder or congenital anomaly Operative or assisted vaginal delivery requiring obstetric intervention Refusal to participate or withdrawal from the study Incomplete study data or inability to complete outcome assessments
About this study
This clinical trial aims to evaluate the effects of a cord clamping bundle developed through the Delphi method on maternal and neonatal outcomes. The study population consists of primiparous women with singleton term pregnancies (37-42 weeks of gestation) who undergo vaginal delivery, along with their healthy newborns.
The primary research questions are:
Read more
Does the Delphi-based cord clamping bundle improve maternal and neonatal physiological outcomes? Does the Delphi-based cord clamping bundle enhance mother-infant bonding and breastfeeding success?
Comparison Group:
Researchers will compare the intervention group, in which the cord clamping bundle is implemented, with the control group receiving routine clinical care to determine the effects of the intervention on maternal and neonatal outcomes.
Participant Involvement:
Participants will provide written and verbal informed consent and complete a personal information form. Following delivery, participants will receive either the cord clamping bundle intervention or routine care according to their assigned group. Data collection will be conducted within the first 24 hours postpartum and will include:
Maternal and neonatal physiological parameters Breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale Amount of postpartum bleeding Placental separation time Time to initiation of breastfeeding Length of hospital stay after delivery.
Read the detailed description
This study aims to evaluate the effects of a cord clamping bundle developed using the Delphi technique on maternal and neonatal outcomes following term vaginal birth. The bundle was developed based on expert consensus to standardize cord clamping practices during the immediate postpartum period.
The study will be conducted among primiparous women with singleton term pregnancies who undergo vaginal delivery and their healthy newborns. Participants will be assigned to either an intervention group receiving the cord clamping bundle or a control group receiving routine cord clamping care according to hospital practice.
Maternal and neonatal physiological outcomes, breastfeeding success, mother-infant bonding, postpartum bleeding, placental separation time, time to initiation of breastfeeding, and length of hospital stay will be evaluated within the first 24 hours after birth. Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool, and mother-infant bonding will be assessed using the Mother-to-Infant Bonding Scale. The findings are expected to contribute to evidence-based cord clamping practices and improve maternal and neonatal care outcomes.BizChat hakkında geri bildirim gönderin
- Being tested
- Cord Clamping Bundle, Routine Cord Clamping Care
- Keywords
- Delayed Cord Clamping, Umbilical Cord Clamping, Cord Clamping Bundle, Maternal Outcomes, Newborn Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord Clamping BundleOther
A standardized cord clamping bundle developed through the Delphi technique based on expert consensus. The intervention includes preparation of sterile materials, delayed umbilical cord clamping until cord pulsations cease (at least 1-3 minutes after birth), sterile cord clamping and cutting, and maintenance of dry cord care.
Routine Cord Clamping CareOther
Routine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle.
| Study group | Role | What they receive |
|---|---|---|
| Cord Clamping Bundle Group | Experimental | Experimental Arm (Cord Clamping Bundle Group)
Intervention:
Delphi-Based Cord Clamping Bundle
Participants in this arm will receive the Delphi-based cord clamping bundle. The bundle includes preparation of sterile materials, delayed cord clamping until cord pulsations cease (at least 1-3 minutes), cord clamping with a sterile umbilical clamp, cutting the cord 4-5 cm from the skin using sterile scissors, and maintaining dry cord care. Receives: Other: Cord Clamping Bundle |
| Routine Cord Clamping Group | Active comparator | Routine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle. Receives: Other: Routine Cord Clamping Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-Infant Bonding
Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale.
Measured: First 24 hours after birth
Secondary outcomes (1)
Mother-Infant Bonding
Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale.
Measured: First 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of a Cord Clamping Bundle on Maternal and Neonatal OutcomesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to either the intervention group receiving the Delphi-based cord clamping bundle or the control group receiving routine cord clamping care. Outcomes will be compared between the two parallel groups during the first 24 hours postpartum.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elif MARANGOZ
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Elif MARANGOZ, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701434
- Sponsor's protocol ID
- CSCH-2025-290
- Acronym
- Cord Clamping
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected during this study will not be made publicly available due to ethical and confidentiality considerations.
Publications
Qiu J, Zhou XG, Zhou XY, Zhu C, Shi CM, Ji CB, Cheng R, Li Y, Guo XR. Characterization of microRNA expression profiles in 3T3-L1 adipocytes overexpressing C10orf116. Mol Biol Rep. 2013 Nov;40(11):6469-76. doi: 10.1007/s11033-013-2762-5. Epub 2013 Sep 20.
PubMed 24052233
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"
- ClinicalTrials.gov ID
- NCT07701434
- Acronym / sponsor ID
- Cord Clamping / CSCH-2025-290
- Keywords
- Delayed Cord Clamping, Umbilical Cord Clamping, Cord Clamping Bundle, Maternal Outcomes, Newborn Outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elif MARANGOZUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 14 Jul 2026 (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 clinical trial aims to evaluate the effects of a cord clamping bundle developed through the Delphi method on maternal and neonatal outcomes. The study population consists of primiparous women with singleton term pregnancies (37-42 weeks of gestation) who undergo vaginal delivery, along with their healthy newborns.
The primary research questions are:
Does the Delphi-based cord clamping bundle improve maternal and neonatal physiological outcomes? Does the Delphi-based cord clamping bundle enhance mother-infant bonding and breastfeeding success?
Comparison Group:
Researchers will compare the intervention group, in which the cord clamping bundle is implemented, with the control group receiving routine clinical care to determine the effects of the intervention on maternal and neonatal outcomes.
Participant Involvement:
Participants will provide written and verbal informed consent and complete a personal information form. Following delivery, participants will receive either the cord clamping bundle intervention or routine care according to their assigned group. Data collection will be conducted within the first 24 hours postpartum and will include:
Maternal and neonatal physiological parameters Breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale Amount of postpartum bleeding Placental separation time Time to initiation of breastfeeding Length of hospital stay after delivery.
Detailed description
This study aims to evaluate the effects of a cord clamping bundle developed using the Delphi technique on maternal and neonatal outcomes following term vaginal birth. The bundle was developed based on expert consensus to standardize cord clamping practices during the immediate postpartum period.
The study will be conducted among primiparous women with singleton term pregnancies who undergo vaginal delivery and their healthy newborns. Participants will be assigned to either an intervention group receiving the cord clamping bundle or a control group receiving routine cord clamping care according to hospital practice.
Maternal and neonatal physiological outcomes, breastfeeding success, mother-infant bonding, postpartum bleeding, placental separation time, time to initiation of breastfeeding, and length of hospital stay will be evaluated within the first 24 hours after birth. Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool, and mother-infant bonding will be assessed using the Mother-to-Infant Bonding Scale. The findings are expected to contribute to evidence-based cord clamping practices and improve maternal and neonatal care outcomes.BizChat hakkında geri bildirim gönderin
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be assigned to either the intervention group receiving the Delphi-based cord clamping bundle or the control group receiving routine cord clamping care. Outcomes will be compared between the two parallel groups during the first 24 hours postpartum.
| Arm | Type | Receives |
|---|---|---|
| Cord Clamping Bundle Group | Experimental | Other: Cord Clamping BundleExperimental Arm (Cord Clamping Bundle Group) Intervention: Delphi-Based Cord Clamping Bundle Participants in this arm will receive the Delphi-based cord clamping bundle. The bundle includes preparation of sterile materials, delayed cord clamping until cord pulsations cease (at least 1-3 minutes), cord clamping with a sterile umbilical clamp, cutting the cord 4-5 cm from the skin using sterile scissors, and maintaining dry cord care. |
| Routine Cord Clamping Group | Active comparator | Other: Routine Cord Clamping CareRoutine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primiparous women Singleton pregnancy Term pregnancy (37-42 weeks of gestation) Vaginal delivery Healthy newborn Mother and newborn discharged together Age 18 years or older Willingness to participate and provide written informed consent
Key exclusion criteria (1 listed)
- High-risk pregnancy Maternal chronic disease Maternal or neonatal conditions affecting breastfeeding Newborn with intrauterine growth restriction (IUGR) Newborn with a genetic disorder or congenital anomaly Operative or assisted vaginal delivery requiring obstetric intervention Refusal to participate or withdrawal from the study Incomplete study data or inability to complete outcome assessments
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 |
|---|---|---|
| Cord Clamping BundleA standardized cord clamping bundle developed through the Delphi technique based on expert consensus. The intervention includes preparation of sterile materials, delayed umbilical cord clamping until cord pulsations cease (at least 1-3 minutes after birth), sterile cord clamping and cutting, and maintenance of dry cord care. | Other | Cord Clamping Bundle Group |
| Routine Cord Clamping CareRoutine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle. | Other | Routine Cord Clamping Group |
Primary outcome
Mother-Infant Bonding
Time frame: First 24 hours after birth
Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale.
1 secondary outcome
Mother-Infant Bonding
Time frame: First 24 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 24052233Qiu J, Zhou XG, Zhou XY, Zhu C, Shi CM, Ji CB, Cheng R, Li Y, Guo XR. Characterization of microRNA expression profiles in 3T3-L1 adipocytes overexpressing C10orf116. Mol Biol Rep. 2013 Nov;40(11):6469-76. doi: 10.1007/s11033-013-2762-5. Epub 2013 Sep 20.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected during this study will not be made publicly available due to ethical and confidentiality considerations.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cord Clamping Bundle and Routine Cord Clamping Care in people with Effects of a Cord Clamping Bundle on Maternal and Neonatal Outcomes, run by Elif MARANGOZ.
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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Mother-Infant Bonding (time frame: First 24 hours after birth). 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 NCT07701434, which also lists 1 linked publication.
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 Jul 2026.