Placental TransfusionNCT04351997
Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
A study testing Cord clamping in people with Placental Transfusion and Hematocrit Anemia, run by Policlinico Abano Terme at 3 sites in Italy.
Trial summary
The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. Read more about this study
- Who is it for?
- Ages 2 to 2 days
- Conditions the study is for
- Placental Transfusion, Hematocrit Anemia
- What is being tested?
- Cord clamping
- 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 Jan 2018to 1 Sep 2018
- 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 2 to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Vaginal delivery Gestational age >37 weeks Natural process of labor
Who cannot join
- Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
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: Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.
Read the detailed description
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine 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 and placental transfusion. The most effective way to manage umbilical cord in in '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 (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by '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
- Placental Transfusion, Hematocrit Anemia
- Being tested
- Cord clamping
- Keywords
- Placental transfusion, Two-step delivery, Early cord clamping, Delayed cord clamping
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord clampingProcedure or surgery
Umbilical cord clamping after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Early cord clamping | Experimental | Cord clamping at 60 seconds after birth. Receives: Procedure: Cord clamping |
| Delayed cord clamping | Experimental | Cord clamping at 180 seconds after birth, Receives: Procedure: Cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental transfusion
We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age.
Measured: Second day of life
Secondary outcomes (5)
Arterial cord blood gas analysis.
Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
Measured: Second day of life.
Neonatal body weight decrease.
Neonatal body weight (Kg) and weight at discharge (Kg)
Measured: First and second day of life
Blood gases
pH (units)
Measured: At birth
Lactate
mmol/L
Measured: At birth
Glucose
mg%
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental TransfusionStudies 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
- The investigators conducted a randomized controlled trial (RCT) ,(parallel group study wit(h 1:1 randomisation) comparing early cord clamping( ECC) (at 60 seconds) and delayed cord clamping DCC) (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
- Masking
- None (open label)
- 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
- NCT04351997
- Sponsor's protocol ID
- 3158/AT/14
- Status last verified
- Apr 2020
- First submitted
- 28 Mar 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery
- ClinicalTrials.gov ID
- NCT04351997
- Acronym / sponsor ID
- 3158/AT/14
- Conditions
- Placental Transfusion, Hematocrit Anemia
- Keywords
- Placental transfusion, Two-step delivery, Early cord clamping, Delayed cord clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Policlinico Abano TermeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 17 Apr 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 RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.
Detailed description
Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine 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 and placental transfusion. The most effective way to manage umbilical cord in in '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 (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.
Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by '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
- None (open label)
- Number of arms
- 2
- Model description
- The investigators conducted a randomized controlled trial (RCT) ,(parallel group study wit(h 1:1 randomisation) comparing early cord clamping( ECC) (at 60 seconds) and delayed cord clamping DCC) (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
| Arm | Type | Receives |
|---|---|---|
| Early cord clamping | Experimental | Procedure: Cord clampingCord clamping at 60 seconds after birth. |
| Delayed cord clamping | Experimental | Procedure: Cord clampingCord clamping at 180 seconds after birth, |
Who may qualify
- Ages
- 2 to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Vaginal delivery Gestational age >37 weeks Natural process of labor
Key exclusion criteria (1 listed)
- Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
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 clampingUmbilical cord clamping after delivery. | Procedure or surgery | Delayed cord clamping, Early cord clamping |
Primary outcome
Placental transfusion
Time frame: Second day of life
We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age.
5 secondary outcomes
Arterial cord blood gas analysis.
Time frame: Second day of life.
Neonatal body weight decrease.
Time frame: First and second day of life
Blood gases
Time frame: At birth
Lactate
Time frame: At birth
Glucose
Time frame: At birth
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 17 Apr 2020.
- 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 Cord clamping in people with Placental Transfusion and Hematocrit Anemia, 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: finished, as of the sponsor's last update on 17 Apr 2020. 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?
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?
Placental transfusion (time frame: Second day of life). 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 17 Apr 2020.