Hematocrit AnemiaNCT04459442
Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping
A study testing Umbilical cord clamping at birth. in people with Hematocrit Anemia and Acidosis, run by Policlinico Abano Terme at 3 sites in Italy.
Trial summary
The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. Read more about this study
- Who is it for?
- Ages 1 minute to 2 days
- Conditions the study is for
- Hematocrit Anemia, Acidosis
- What is being tested?
- Umbilical cord clamping at birth.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Feb 2021to 30 Dec 2021
- 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 1 minute to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Vaginal delivery
Who cannot join
- Cesarean delivery
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Policlinico Abano Terme
Abano Terme, Padua, 35031
Policlinico Abano Terme
Abano Terme
Padua University Hospital
Padua, 35128
About this study
Official title: Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping
The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental acidosis.
Read the detailed description
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable transition from fetal to extrauterine life, with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during' natural', 'two-step delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values (placental transfusion). The most effective way to manage umbilical cord in in 'natural', two-step delivery remains to be established. Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management ECC vs. DCC) on the placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.
Material and methods: This is a randomized clinical trial on the effect of different cord management in newborns by 'natural', two-step delivery. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio, according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).
- Conditions
- Hematocrit Anemia, Acidosis
- Being tested
- Umbilical cord clamping at birth.
- Keywords
- Placental transfusion, Natural, two-step delivery, Early cord clamping, Delayed cord clamping
- Medical subject headings
- Acidosis, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord clamping at birth.Procedure or surgery
Also called Cord clamping
Umbilical cord clamping after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Early cord clamping | Experimental | Cord clamping at 60 seconds after birth. Receives: Procedure: Umbilical cord clamping at birth. |
| Delayed cord clamping | Experimental | Cord clamping at 180 seconds after birth. Receives: Procedure: Umbilical cord clamping at birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental transfusion.
Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.
Measured: Second day of life
Cord blood pH
pH estimate in arterial cord blood gas analysis
Measured: Second day of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Feb 2021
- Primary completion15 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematocrit AnemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Abano Terme
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Zanardo, Policlinico Abano Terme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459442
- Sponsor's protocol ID
- 3278/AT/14
- Status last verified
- Sep 2021
- First submitted
- 1 Jul 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Transfusion in the 'Natural' Vaginal Delivery at Term: Effect of Early and Late Umbilical Cord Clamping
- ClinicalTrials.gov ID
- NCT04459442
- Acronym / sponsor ID
- 3278/AT/14
- Conditions
- Hematocrit Anemia, Acidosis
- Keywords
- Placental transfusion, Natural, two-step delivery, Early cord clamping, Delayed cord clamping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Policlinico Abano TermeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 Jul 2020 (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 investigators conducted a randomized controlled trial (parallel group study with 1:1 randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental acidosis.
Detailed description
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable transition from fetal to extrauterine life, with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during' natural', 'two-step delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values (placental transfusion). The most effective way to manage umbilical cord in in 'natural', two-step delivery remains to be established. Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management ECC vs. DCC) on the placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.
Material and methods: This is a randomized clinical trial on the effect of different cord management in newborns by 'natural', two-step delivery. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio, according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.
| Arm | Type | Receives |
|---|---|---|
| Early cord clamping | Experimental | Procedure: Umbilical cord clamping at birth.Cord clamping at 60 seconds after birth. |
| Delayed cord clamping | Experimental | Procedure: Umbilical cord clamping at birth.Cord clamping at 180 seconds after birth. |
Who may qualify
- Ages
- 1 minute to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Vaginal delivery
Key exclusion criteria (1 listed)
- Cesarean delivery
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 at birth.Also: Cord clampingUmbilical cord clamping after delivery. | Procedure or surgery | Delayed cord clamping, Early cord clamping |
Primary outcome
Placental transfusion.
Time frame: Second day of life
Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.
Cord blood pH
Time frame: Second day of life.
pH estimate in arterial cord blood gas analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No. No. There is not a plan to make IPD available
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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.
3 sites 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 at birth. in people with Hematocrit Anemia and Acidosis, run by Policlinico Abano Terme at 3 sites 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 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Placental transfusion. (time frame: Second day of life). 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?
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 16 Sep 2021.