Cesarean SectionINTACTNCT05461950
Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
An observational study of Cesarean Section and Infant Conditions, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants. Read more about this study
- Who is it for?
- Ages 32 to 42 weeks, women only
- Conditions the study is for
- Cesarean Section, Infant Conditions
- What is being tested?
- Extrauterine placental transfusion and physiology-based umbilical cord clamping, Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping and Delayed umbilical cord clamping
- Type of treatment
- Surgery or procedure
- How many people
- 263 participants
- Where
- 1 siteNorway
- Study dates
- 3 Oct 2022to 31 Mar 2024
- 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 32 to 42 weeks
- Women only
- No healthy volunteers
- Child
Study population: Women planning to give birth at Clinic Ålesund are candidates for enrolment in this clinical study. Pregnant women will be invited to participate when called for second trimester routine ultrasound scan. They will be asked for preliminary consent in the event of intrapartum or planned cesarean section and fullfilment of inclusion cirteria. Women having ultrasound scans done elsewhere, who are later referred to Clinic Ålesund, may be invited to participate after admission, but will not be approached for consent if delivery is imminent. Both parents (if applicable) must consent on behalf of their infant
Who may be able to join
- live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0
- delivered by CS in regional anaesthesia
- immediate care may be planned with involved personnel prior to delivery
- informed maternal consent is obtained (parental consent on behalf of the unborn child).
Who cannot join
- twins, triplets
- significant congenital malformations
- placenta complications with high risk of abnormal maternal blood loss
- severe fetal distress requiring cesarean section in general anaesthesia (crash CS)
- participation in any other clinical study within the last month
- not sufficient time for preparations or collection of maternal/parental consent
- mother does not comprehend Norwegian or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility-testing of Extra-uterine Placental Transfusion to Facilitate Intact-cord Stabilisation and Physiology-based Cord Clamping for Term and Preterm Infants Delivered by Acute or Planned Caesarean Section
This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.
Read the detailed description
Standard procedure when an infant is delivered by caesarean section is to wait to clamp the umbilical cord for approximately one minute, and then transfer the infant to a designated area for assessment and stabilisation. If the infant needs immediate resuscitation, the umbilical cord is cut earlier to expedite transfer to resuscitation equipment and qualified care (including stimulation, clearing airways and respiratory support).
It has been suggested in several pilot and clinical studies that keeping the umbilical cord intact during the infant's transition from intra- to extrauterine life may improve outcomes and survival, especially for preterm infants. Since length of the umbilical cord is limited, finding ways to avoid cutting the cord while initiating stabilisation and care is warranted. To date, most studies have reported on interventions that involve mobile resuscitation equipment; thus keeping the infant in close proximity to the mother. This may be extra challenging in caesareans sections, especially due to space constraints and maintenance of sterility.
The objective of this study to determine whether extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by caesarean section is feasible, safe and acceptable for infants and their mothers, as well as for involved personnel.
- Conditions
- Cesarean Section, Infant Conditions
- Being tested
- Extrauterine placental transfusion and physiology-based umbilical cord clamping, Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping, Delayed umbilical cord clamping
- Keywords
- infant stabilisation, intact umbilical cord, umbilical cord clamping, placental transfusion, cesarean section
- Medical subject headings
- Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extrauterine placental transfusion and physiology-based umbilical cord clampingProcedure or surgery
Placenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room, the umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infants is breathing regularly (within 10 minutes after delivery)
Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clampingProcedure or surgery
Placenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room and necessary respiratory support is initiated (CPAP or PPV) by a neonatal team. The umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infant is breathing regularly with or without support (at maximum 10 minutes after delivery)
Delayed umbilical cord clampingProcedure or surgery
Umbilical cord is clamped and cut minimum 60 seconds after delivery to facilitate placental transfusion. Placenta is delivered after cord clamping. Infants needing respiratory support or other stabilisation are transferred to a warmer in the adjacent room where a neonatal team is waiting.
| Study group | Role | What they receive |
|---|---|---|
| Self-breathing infants | Vigorous infants with spontaneous onset of respiration within one minute after delivery by cesarean section, receiving extra-uterine placental transfusion and physiology-based cord clamping Receives: Procedure: Extrauterine placental transfusion and physiology-based umbilical cord clamping | |
| Infants with respiratory support | Infants with no or poor spontaneous onset of respiration after delivery by cesarean section, receiving extra-uterine placental transfusion, intact-cord stabilisation (any respiratory support) and physiology-based cord clamping after transfer to resuscitation table Receives: Procedure: Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping | |
| Historical control group | Infants delivered by cesarean section in a time period when delayed cord clamping after 1-3 minutes was default procedure. Less-than-vigorous infants needing respiratory support or full resuscitation had their umbilical cords cut early (within 30 seconds) Receives: Procedure: Delayed umbilical cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention fidelity (cohort 1)
Extra-uterine placental transfusion + physiology-based cord clamping applied (for vigorous infants), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.
Measured: First 10 minutes after delivery
Intervention fidelity (cohort 2)
Extra-uterine placental transfusion + intact-cord stabilisation + physiology-based cord clamping applied (for infants needing any respiratory support), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.
Measured: First 10 minutes after delivery
Secondary outcomes (14)
Dry-electrode ECG attached (cohort 1+2)
Time from birth to dry-electrode ECG (NeoBeat) is attached to the infant's chest or abdomen (measured in seconds). Registered on a checklist by a time-keeper in the operating room.
Measured: Within 10 seconds after birth
First cry or breathing effort (cohort 1+2)
Time from birth to infant's first cry or attempt of spontaneous breathing (measured in minutes and seconds). Assessed by attending midwife or pediatric registrar. Registered on a checklist by a time-keeper in the operating room.
Measured: Within 10 minutes after birth
Heart rate (cohort 1+2)
Infant's heart rate after birth measured by a dry-electrode ECG (NeoBeat). Registered on a special data collection sheet by a timekeeper or attending midwife. Data are transferred wirelessly from the NeoBeat device to the Liveborn App (installed on a designated tablet) for storage and further analysis.
Measured: First 10 -15 minutes after birth
Umbilical cord blood samples (cohort 1+2)
Time from birth to sampling for umbilical cord blood gas analysis (arterial and venous) completed (measured in seconds). Registered on a checklist by a time-keeper in the operating room.
Measured: Within 40-60 seconds after birth
Apgar score (cohort 1+2)
Composite of heart rate, breathing effort, skin colour, muscle tone and reflexes (each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Assessed by the attending midwife or pediatric registrar, registered on a special data collection sheet by a timekeeper in the operating room
Measured: At 1 minute after birth
Delivery of placenta (cohort 1+2)
Time from birth to delivery of the placenta (measured in minutes ans seconds), registered on checklist by a time-keeper in the operating room
Measured: At 1 minute (+/- 10 seconds) after birth
Respiratory support (cohort 2)
Type of respiratory support applied. Alternatives are: CPAP (Continuous Positive Airway Pressure) or PPV (Positive Pressure Ventilation) Registered on a special data collection sheet by the attending neonatal team or midwife
Measured: First 10-15 minutes after birth
Duration of respiratory support (cohort 2)
Duration of respiratory support (CPAP or PPV), measured in minutes and seconds. Registered on a special data collection sheet by the attending neonatal team or midwife
Measured: First 10-15 minutes after birth
Apgar score
Composite of heart rate, breathing effort, skin colour, muscle tone and reflexes (each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Assessed and registered on a special data collection sheet by the attending midwife or neonatal nurse
Measured: At 5 minutes after birth (cohort 1+2)
Stabilisation (cohort 2)
Time from birth to stabilisation achieved (regular breathing, heartrate (HR) >100, Saturation (SpO2) >85%, inspired oxygen fraction (FiO2) <40%. Measured in minutes and seconds. Assessed and registered on a special data collection sheet by the attending midwife or neonatal nurse
Measured: Within 10-20 minutes after birth
Cord clamping time (cohort 1+2)
Time from birth to umbilical cord clamping (measured in minutes and seconds), registered on a special data collection sheet by the attending midwife
Measured: Within 10 minutes after birth
Apgar score (cohort 1+2)
Composite of heart rate, breathing effort, skin colour, muscle tone and reflexes (each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Assessed and registered on a special data collection sheet by the attending midwife or neonatal nurse
Measured: At 10 minutes after birth
Skin-to-skin-contact (cohort 1+2)
Time from birth to continuous skin-to-skin contact between infant and mother (or other parent), measured in minutes. Registered on a checklist by the attending midwife or neonatal nurse
Measured: Within 2 hours after birth
Residual placenta volume (cohort 1+2)
Drained and weighed residual blood volume from placenta and umbilical cord after cord clamping (measured in grams, converted to milliliters by a ratio of 1.05:1). Registered by the attending midwife or assistant nurse
Measured: Within 10-15 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start3 Oct 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Beate H Eriksen, MD/PhD, Principal investigator, Møre and Romsdal Hosptal Trust / Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461950
- Sponsor's protocol ID
- 399101
- Acronym
- INTACT
- Status last verified
- Jun 2024
- First submitted
- 13 Jul 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility-testing of Extra-uterine Placental Transfusion to Facilitate Intact-cord Stabilisation and Physiology-based Cord Clamping for Term and Preterm Infants Delivered by Acute or Planned Caesarean Section
- ClinicalTrials.gov ID
- NCT05461950
- Acronym / sponsor ID
- INTACT / 399101
- Conditions
- Cesarean Section, Infant Conditions
- Keywords
- infant stabilisation, intact umbilical cord, umbilical cord clamping, placental transfusion, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 18 Jul 2022 (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 is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord stabilisation of preterm and term newborn infants.
Detailed description
Standard procedure when an infant is delivered by caesarean section is to wait to clamp the umbilical cord for approximately one minute, and then transfer the infant to a designated area for assessment and stabilisation. If the infant needs immediate resuscitation, the umbilical cord is cut earlier to expedite transfer to resuscitation equipment and qualified care (including stimulation, clearing airways and respiratory support).
It has been suggested in several pilot and clinical studies that keeping the umbilical cord intact during the infant's transition from intra- to extrauterine life may improve outcomes and survival, especially for preterm infants. Since length of the umbilical cord is limited, finding ways to avoid cutting the cord while initiating stabilisation and care is warranted. To date, most studies have reported on interventions that involve mobile resuscitation equipment; thus keeping the infant in close proximity to the mother. This may be extra challenging in caesareans sections, especially due to space constraints and maintenance of sterility.
The objective of this study to determine whether extra-uterine placental transfusion to facilitate intact-cord stabilisation and physiology-based cord clamping for infants delivered by caesarean section is feasible, safe and acceptable for infants and their mothers, as well as for involved personnel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-breathing infants | – | Procedure: Extrauterine placental transfusion and physiology-based umbilical cord clampingVigorous infants with spontaneous onset of respiration within one minute after delivery by cesarean section, receiving extra-uterine placental transfusion and physiology-based cord clamping |
| Infants with respiratory support | – | Procedure: Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clampingInfants with no or poor spontaneous onset of respiration after delivery by cesarean section, receiving extra-uterine placental transfusion, intact-cord stabilisation (any respiratory support) and physiology-based cord clamping after transfer to resuscitation table |
| Historical control group | – | Procedure: Delayed umbilical cord clampingInfants delivered by cesarean section in a time period when delayed cord clamping after 1-3 minutes was default procedure. Less-than-vigorous infants needing respiratory support or full resuscitation had their umbilical cords cut early (within 30 seconds) |
Who may qualify
- Ages
- 32 to 42 weeks
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Women planning to give birth at Clinic Ålesund are candidates for enrolment in this clinical study. Pregnant women will be invited to participate when called for second trimester routine ultrasound scan. They will be asked for preliminary consent in the event of intrapartum or planned cesarean section and fullfilment of inclusion cirteria. Women having ultrasound scans done elsewhere, who are later referred to Clinic Ålesund, may be invited to participate after admission, but will not be approached for consent if delivery is imminent. Both parents (if applicable) must consent on behalf of their infant
Key inclusion criteria (4 listed)
- live infants (singletons or dichorionic twins) born in gestational week 32+0 to 42+0
- delivered by CS in regional anaesthesia
- immediate care may be planned with involved personnel prior to delivery
- informed maternal consent is obtained (parental consent on behalf of the unborn child).
Key exclusion criteria (7 listed)
- twins, triplets
- significant congenital malformations
- placenta complications with high risk of abnormal maternal blood loss
- severe fetal distress requiring cesarean section in general anaesthesia (crash CS)
- participation in any other clinical study within the last month
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 |
|---|---|---|
| Extrauterine placental transfusion and physiology-based umbilical cord clampingPlacenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room, the umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infants is breathing regularly (within 10 minutes after delivery) | Procedure or surgery | Self-breathing infants |
| Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clampingPlacenta is delivered prior to umbilical cord clamping to facilitate placental transfusion. Infant and placenta are transferred to a warmer in an adjacent room and necessary respiratory support is initiated (CPAP or PPV) by a neonatal team. The umbilical cord is clamped and cut when the cord is white, pulsations have ceased and the infant is breathing regularly with or without support (at maximum 10 minutes after delivery) | Procedure or surgery | Infants with respiratory support |
| Delayed umbilical cord clampingUmbilical cord is clamped and cut minimum 60 seconds after delivery to facilitate placental transfusion. Placenta is delivered after cord clamping. Infants needing respiratory support or other stabilisation are transferred to a warmer in the adjacent room where a neonatal team is waiting. | Procedure or surgery | Historical control group |
Primary outcome
Intervention fidelity (cohort 1)
Time frame: First 10 minutes after delivery
Extra-uterine placental transfusion + physiology-based cord clamping applied (for vigorous infants), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.
Intervention fidelity (cohort 2)
Time frame: First 10 minutes after delivery
Extra-uterine placental transfusion + intact-cord stabilisation + physiology-based cord clamping applied (for infants needing any respiratory support), measured as proportion of completed checklists. Registered by staff, using checklists in the operating room.
14 secondary outcomes
Dry-electrode ECG attached (cohort 1+2)
Time frame: Within 10 seconds after birth
First cry or breathing effort (cohort 1+2)
Time frame: Within 10 minutes after birth
Heart rate (cohort 1+2)
Time frame: First 10 -15 minutes after birth
Umbilical cord blood samples (cohort 1+2)
Time frame: Within 40-60 seconds after birth
Apgar score (cohort 1+2)
Time frame: At 1 minute after birth
Delivery of placenta (cohort 1+2)
Time frame: At 1 minute (+/- 10 seconds) after birth
Respiratory support (cohort 2)
Time frame: First 10-15 minutes after birth
Duration of respiratory support (cohort 2)
Time frame: First 10-15 minutes after birth
Apgar score
Time frame: At 5 minutes after birth (cohort 1+2)
Stabilisation (cohort 2)
Time frame: Within 10-20 minutes after birth
Cord clamping time (cohort 1+2)
Time frame: Within 10 minutes after birth
Apgar score (cohort 1+2)
Time frame: At 10 minutes after birth
Skin-to-skin-contact (cohort 1+2)
Time frame: Within 2 hours after birth
Residual placenta volume (cohort 1+2)
Time frame: Within 10-15 minutes after 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 4 Jun 2024.
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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.
Beate H Eriksen, MD/PhD principal investigator
Møre and Romsdal Hosptal Trust / Norwegian University of Science and Technology
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 Cesarean Section and Infant Conditions, run by Helse Møre og Romsdal HF at 1 site in Norway.
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 7 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 4 Jun 2024. 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 Norway. 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?
Intervention fidelity (cohort 1) (time frame: First 10 minutes after delivery). 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 4 Jun 2024.