Intact Cord Placental DeliveryTTCNCT07713277
Intact Cord Placental Delivery vs Delayed Cord Clamping
An observational study of Intact Cord Placental Delivery and Delayed Cord Clamping, run by Azienda ULSS 8 Berica at 1 site in Italy.
Trial summary
The management of the third stage of labour plays a critical role in neonatal transition. Uninterrupted Intact Cord Clamping (UICC), is a clinical approach where the umbilical cord remains unclamped until the placenta is spontaneously expelled. 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
- Intact Cord Placental Delivery, Delayed Cord Clamping, Standard Delayed Cord Clamping
- How many people
- 1,979 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2026to 31 Jul 2027
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population consists of women at full term, who have had a vaginal delivery, and healthy newborns without perinatal complications. The target population also includes late-preterm infants and those with intrauterine growth restriction (IUGR) who have normal fetal Doppler
Who may be able to join
- Singleton pregnancy (≥34+0 weeks of gestation).
- Spontaneous eutocic vaginal delivery.
- Healthy newborn with a birth weight of ≥2500 grams (appropriate for gestational age).
- Informed consent signed by both the patient and her partner.
Who cannot join
- Maternal Medical Conditions
- Chronic or Pregnancy-Induced Hypertensive Disorders: Including chronic hypertension, pre-eclampsia, and HELLP syndrome.
- Systemic Diseases: Pre-existing autoimmune diseases, significant cardiovascular diseases, or metabolic disorders that may interfere with placental function.
- Haematological Disorders: Known maternal coagulopathies, severe anaemia (Haemoglobin < 8 g/dL), or other blood dyscrasias.
- Obstetric Complications and Emergencies
- Placental Anomalies: Suspected or confirmed placental abruption, placenta previa, or morbidly adherent placenta (accreta/increta/percreta).
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- Acute Intrapartum Complications: Umbilical cord prolapse, suspected chorioamnionitis (intra-amniotic infection), or significant antepartum haemorrhage.
- Operative or Instrumental Delivery: Any requirement for urgent operative vaginal delivery (vacuum or forceps) or conversion to Emergency Caesarean Section.
- Pre-existing Risk for PPH: History of severe Postpartum Haemorrhage in previous pregnancies.
- Neonatal Factors
- Acute Neonatal Distress: Requirement for immediate neonatal resuscitation at birth that precludes waiting for placental expulsion.
- Congenital Anomalies: Presence of major congenital malformations or chromosomal abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bond That Nurtures: Neonatal and Maternal Outcomes of Intact Cord Placental Delivery vs Delayed Cord Clamping
The management of the third stage of labour plays a critical role in neonatal transition. Uninterrupted Intact Cord Clamping (UICC), is a clinical approach where the umbilical cord remains unclamped until the placenta is spontaneously expelled. This method aims to facilitate the maximum physiological transfer of placental blood to the newborn.
While Delayed Cord Clamping (DCC)-typically defined as clamping between 1 and 3 minutes or until pulsations cease-is widely supported by literature for its ability to improve neonatal iron stores and reduce morbidity and mortality without increasing maternal-foetal risk, there is currently a lack of robust evidence regarding the systematic practice of Uninterrupted Intact Cord Clamping (UICC), defined as clamping only after placental delivery. This gap in the literature necessitates a thorough investigation into the potential benefits and safety of UICC.
Read the detailed description
Uninterrupted Intact Cord Clamping (UICC) requires waiting for the placenta to be expelled spontaneously before clamping the umbilical cord; this management of the third stage of labour facilitates the complete physiological transfer of placental blood to the newborn. Several studies have suggested that Delayed Cord Clamping (DCC) increases and improves neonatal blood reserves, ensuring more favourable outcomes in terms of neonatal morbidity and mortality without increasing maternal-foetal risk.
Although there is a wealth of literature on the benefits of DCC at 1-3 minutes, the same cannot be said for UICC; hence the need for a thorough investigation of the subject. The overall aim of the study is to compare maternal and neonatal outcomes between UICC and DCC (3 minutes or until pulsations cease), through a single-centre prospective observational study.
- Conditions
- Intact Cord Placental Delivery, Delayed Cord Clamping, Standard Delayed Cord Clamping, Timing of Cord Clamping, Postpartum Hemorrhage (Primary)
- Keywords
- ICPD, DCC, Intact Cord Placental Delivery, Delayed Cord Clamping, Third stage of labour, Early Cord Clamping, ECC, Immediate Cord Clamping, ICC, TTC, Very Delayed Clamping, VDC, PPH, Obstetric hemorrhage, Postpartum Hemorrhage, AMTSL, Active Management of the Third Stage of Labour
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intact cord placental delivery cohort | Infants in the intact cord placental delivery (ICPD) group, with clamping performed following placental expulsion | |
| Delayed cord clamping (DCC) prior to placental expulsion | Cohort of infants for whom delayed cord clamping was performed before the expulsion of the placenta, ensuring the standard DCC protocol was maintained. Clamping performed between 60 seconds and 3 minutes after birth or Clamping performed only after the cessation of umbilical cord pulsations, which may extend beyond 3 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcome: Postpartum blood loss
2-hour postpartum blood loss
Measured: during the immediate postpartum period (0-2 hours)
Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP)
The rate of retained placenta, defined as the failure of the placenta to be expelled within 30-60 minutes of birth, necessitating Manual Removal of the Placenta (MROP) under anaesthesia
Measured: Within two hours of birth
Neonatal outcome: Requirement for phototherapy
Incidence of neonates requiring phototherapy for hyperbilirubinemia
Measured: During the hospital stay (up to 3 days)
Neonatal outcome: physiological weight loss during the early neonatal period
The study will monitor the neonatal physiological weight loss from birth until hospital discharge to evaluate its correlation with placental transfusion volume
Measured: During the hospital stay (up to 3 days)
Secondary outcomes (5)
Maternal outcome: duration of the third stage of labour
This maternal outcome will be the time from neonatal birth to placental expulsion, comparing the efficiency of the third stage between the two study groups
Measured: Within two hours of birth
Neonatal outcome: apgar scores at 1, 5, and 10 minutes
Secondary neonatal outcomes include the assessment of Apgar scores at 1, 5, and 10 minutes to evaluate the immediate clinical status and transition of the newborn, higher values indicate superior neonatal clinical status.
Measured: within 10 minutes of birth
Neonatal outcome: umbilical artery pH at delivery
Secondary neonatal outcomes include the assessment of arterial cord blood pH at birth to evaluate the metabolic status and the quality of the transition to extrauterine life
Measured: within 10 minutes of birth
Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method
The study assesses the need for neonatal resuscitation and NICU admission, with the primary clinical variable being intact cord placental delivery versus standard clamping
Measured: During the hospital stay (up to 3 days)
Neonatal outcome: haematocrit (Hct) levels at 24 hours of life
Measured: within 24 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Apr 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intact Cord Placental DeliveryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,979 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda ULSS 8 Berica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca carolo, Study chair, Aulss 8 Berica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713277
- Sponsor's protocol ID
- BPM 3
- Other IDs
- COMITATO ETICO TERRITORIALE
- Acronym
- TTC
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The entire IPD cohort
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bond That Nurtures: Neonatal and Maternal Outcomes of Intact Cord Placental Delivery vs Delayed Cord Clamping
- ClinicalTrials.gov ID
- NCT07713277
- Acronym / sponsor ID
- TTC / BPM 3
- Conditions
- Intact Cord Placental Delivery, Delayed Cord Clamping, Standard Delayed Cord Clamping, Timing of Cord Clamping, Postpartum Hemorrhage (Primary)
- Keywords
- ICPD, DCC, Intact Cord Placental Delivery, Delayed Cord Clamping, Third stage of labour, Early Cord Clamping, ECC, Immediate Cord Clamping
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,979 participants (estimated)
- Lead sponsor
- Azienda ULSS 8 BericaUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 20 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.
The management of the third stage of labour plays a critical role in neonatal transition. Uninterrupted Intact Cord Clamping (UICC), is a clinical approach where the umbilical cord remains unclamped until the placenta is spontaneously expelled. This method aims to facilitate the maximum physiological transfer of placental blood to the newborn.
While Delayed Cord Clamping (DCC)-typically defined as clamping between 1 and 3 minutes or until pulsations cease-is widely supported by literature for its ability to improve neonatal iron stores and reduce morbidity and mortality without increasing maternal-foetal risk, there is currently a lack of robust evidence regarding the systematic practice of Uninterrupted Intact Cord Clamping (UICC), defined as clamping only after placental delivery. This gap in the literature necessitates a thorough investigation into the potential benefits and safety of UICC.
Detailed description
Uninterrupted Intact Cord Clamping (UICC) requires waiting for the placenta to be expelled spontaneously before clamping the umbilical cord; this management of the third stage of labour facilitates the complete physiological transfer of placental blood to the newborn. Several studies have suggested that Delayed Cord Clamping (DCC) increases and improves neonatal blood reserves, ensuring more favourable outcomes in terms of neonatal morbidity and mortality without increasing maternal-foetal risk.
Although there is a wealth of literature on the benefits of DCC at 1-3 minutes, the same cannot be said for UICC; hence the need for a thorough investigation of the subject. The overall aim of the study is to compare maternal and neonatal outcomes between UICC and DCC (3 minutes or until pulsations cease), through a single-centre prospective observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intact cord placental delivery cohort | – | –Infants in the intact cord placental delivery (ICPD) group, with clamping performed following placental expulsion |
| Delayed cord clamping (DCC) prior to placental expulsion | – | –Cohort of infants for whom delayed cord clamping was performed before the expulsion of the placenta, ensuring the standard DCC protocol was maintained. Clamping performed between 60 seconds and 3 minutes after birth or Clamping performed only after the cessation of umbilical cord pulsations, which may extend beyond 3 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of women at full term, who have had a vaginal delivery, and healthy newborns without perinatal complications. The target population also includes late-preterm infants and those with intrauterine growth restriction (IUGR) who have normal fetal Doppler
Key inclusion criteria (4 listed)
- Singleton pregnancy (≥34+0 weeks of gestation).
- Spontaneous eutocic vaginal delivery.
- Healthy newborn with a birth weight of ≥2500 grams (appropriate for gestational age).
- Informed consent signed by both the patient and her partner.
Key exclusion criteria (12 listed)
- Maternal Medical Conditions
- Chronic or Pregnancy-Induced Hypertensive Disorders: Including chronic hypertension, pre-eclampsia, and HELLP syndrome.
- Systemic Diseases: Pre-existing autoimmune diseases, significant cardiovascular diseases, or metabolic disorders that may interfere with placental function.
- Haematological Disorders: Known maternal coagulopathies, severe anaemia (Haemoglobin < 8 g/dL), or other blood dyscrasias.
- Obstetric Complications and Emergencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal outcome: Postpartum blood loss
Time frame: during the immediate postpartum period (0-2 hours)
2-hour postpartum blood loss
Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP)
Time frame: Within two hours of birth
The rate of retained placenta, defined as the failure of the placenta to be expelled within 30-60 minutes of birth, necessitating Manual Removal of the Placenta (MROP) under anaesthesia
Neonatal outcome: Requirement for phototherapy
Time frame: During the hospital stay (up to 3 days)
Incidence of neonates requiring phototherapy for hyperbilirubinemia
Neonatal outcome: physiological weight loss during the early neonatal period
Time frame: During the hospital stay (up to 3 days)
The study will monitor the neonatal physiological weight loss from birth until hospital discharge to evaluate its correlation with placental transfusion volume
5 secondary outcomes
Maternal outcome: duration of the third stage of labour
Time frame: Within two hours of birth
Neonatal outcome: apgar scores at 1, 5, and 10 minutes
Time frame: within 10 minutes of birth
Neonatal outcome: umbilical artery pH at delivery
Time frame: within 10 minutes of birth
Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method
Time frame: During the hospital stay (up to 3 days)
Neonatal outcome: haematocrit (Hct) levels at 24 hours of life
Time frame: within 24 hours of 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 20 Jul 2026.
- Individual participant dataSharing planned: Yes. The entire IPD cohort
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.
Francesca carolo study chair
Aulss 8 Berica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intact Cord Placental Delivery and Delayed Cord Clamping, run by Azienda ULSS 8 Berica at 1 site in Italy.
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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. 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 Italy. 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?
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?
Maternal outcome: Postpartum blood loss (time frame: during the immediate postpartum period (0-2 hours)). The study lists 4 primary outcomes in all. 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 20 Jul 2026.