Placental TransfusionNCT03668782
Cord Milking in Elective Cesarean Section
An observational study of Placental Transfusion, run by Policlinico Abano Terme at 1 site in Italy.
Trial summary
The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates. Read more about this study
- Who is it for?
- Ages 1 minute to 2 days
- Conditions the study is for
- Placental Transfusion
- What is being tested?
- Umbilical cord milking
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2018to 28 Feb 2019
- Phase
- Observational
- 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
Study population: All women who presented for an elective cesarean section were screened for eligibility.
Inclusion Criteria: singleton low risk pregnancy, gestational age of 39 to 40/0 weeks confirmed by a first trimester ultrasound, no evidence of active labor, 18 years of age, and (5) a written consent given by the woman.
-
Exclusion Criteria:maternal medical and obstetric complications, severe anemia, clotting disorders and suspected intrauterine growth restriction
-
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico Abano Terme
Abano Terme
Vincenzo Zanardo, ND, 049720027 ext. +39, viincenzo.zanardo@libero.it
About this study
Official title: Efficacy of Umbilical Cord Milking in Elective Cesarean Section
The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.
- Conditions
- Placental Transfusion
- Being tested
- Umbilical cord milking
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
Also called Immediate cord clamping
The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.
| Study group | Role | What they receive |
|---|---|---|
| immediate cord clamping | Tthe umbilical cord of neonates was cut and clamped. Receives: Procedure: Umbilical cord milking | |
| umbilical cord milking. | Tthe umbilical cord of neonates was milked. Receives: Procedure: Umbilical cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental transfusion
Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion28 Feb 2019 (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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
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
- NCT03668782
- Sponsor's protocol ID
- 24/2018 Fondazione Leonardo
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zanardo V, Guerrini P, Severino L, Simbi A, Parotto M, Straface G. A Randomized Controlled Trial of Intact Cord Milking versus Immediate Cord Clamping in Term Infants Born by Elective Cesarean Section. Am J Perinatol. 2021 Mar;38(4):392-397. doi: 10.1055/s-0039-1697673. Epub 2019 Oct 10.
PubMed 31600796
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Umbilical Cord Milking in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT03668782
- Acronym / sponsor ID
- 24/2018 Fondazione Leonardo
- Conditions
- Placental Transfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Policlinico Abano TermeUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 13 Sep 2018 (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 objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate cord clamping | – | Procedure: Umbilical cord milkingTthe umbilical cord of neonates was cut and clamped. |
| umbilical cord milking. | – | Procedure: Umbilical cord milkingTthe umbilical cord of neonates was milked. |
Who may qualify
- Ages
- 1 minute to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All women who presented for an elective cesarean section were screened for eligibility.
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 milkingAlso: Immediate cord clampingThe babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped. | Procedure or surgery | immediate cord clamping, umbilical cord milking. |
Primary outcome
Placental transfusion
Time frame: 48 hours
Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Derived from this study: PubMed 31600796Zanardo V, Guerrini P, Severino L, Simbi A, Parotto M, Straface G. A Randomized Controlled Trial of Intact Cord Milking versus Immediate Cord Clamping in Term Infants Born by Elective Cesarean Section. Am J Perinatol. 2021 Mar;38(4):392-397. doi: 10.1055/s-0039-1697673. Epub 2019 Oct 10.
- Individual participant dataSharing planned: No
Related trials for Placental Transfusion
Recruiting
Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile
Premature, Placental Transfusion
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.
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 Placental Transfusion, run by Policlinico Abano Terme 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?
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 13 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placental transfusion (time frame: 48 hours). 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 NCT03668782, 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 13 Sep 2018; AzTrials last refreshed its copy on 30 Oct 2026.