Sustained Cord Circulation at Emergency Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age37-42
SponsorRegion Skane
About this trial
The goal of this clinical trial is to evaluate if sustained cord circulation during resuscitation improves outcomes for term neonates born by emergency Cesarean section. The main question it aims to answer is: Does sustained cord circulation reduce admission rates to neonatal care?
Researchers will compare resuscitation with an uncut umblical cord to standard resuscitation practices to see if it provides better outcomes.
Participants (term neonates born by emergency Cesarean section) will:
Receive resuscitation with either sustained cord circulation or standard care Be monitored for admission to neonatal care and other predefined health outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Singleton neonate
Born alive
Gestational age ≥37 weeks
Born by emergency cesarean section, epidural/spinal anesthesia, where the pediatric/neonatal team has been called for to attend.
Disqualifiers
Major congenital malformation that may affect resuscitation or outcome measures.
Major genetic disorder that may affect resuscitation or outcome measures.
Trial design
Design model
Parallel
Treatments tested in this trial
Sustained cord (≥ 180 seconds) resuscitation
Procedure/SurgeryResuscitation performed in near proximity to the mother with umbilical cord uncut
Routine (< 60 seconds) cord clamping
Procedure/SurgeryResuscitation performed at a designated area after umbilical cord is cut
Treatment groups
2,200 Participants
are divided into 2 treatment groupsGroup A: Intact cordExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite outcome of admission to neonatal care for predefined criteria and death before admission.
Admission to neonatal care is collected from the Swedish Neonatal Quality registry (SNQ), as are criteria for admission:• Asphyxia at birth (One-, Five- and/or Ten-minute Apgar score \<4), diagnosis P21.0, P21.1A, P21.1B or P21.9.• Respiratory distress (Noted in SNQ as NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistant Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1).• Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X.• Hypoglycemia, P 70.4A, or B. Death of the neonate before admission is collected from Swedish pregnancy registry. Units of measure is dichotomous, as appearance of the diagnoses or not.
Time frame
At one hour after birthSecondary outcomes
1
Apgar score at 5 min
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.
Time frame
5 minutes2
Apgar score at 10 min
Assessed by staff, composite of heart rate, breathing effort, skin color, muscle tone and reflexes, each sub scale 0 (absent), 1, 2 (normal). Minimum 0, maximum 10. Less than 4 is a measure for severe asphyxia, less than 7 measure of mild asphyxia.
Time frame
10 minutes3
Respiratory distress as a diagnosis after birth
Having the at least one of the following diagnosis in the Swedish neonatal quality registry: NAS, neonatal respiratory distress P22.8, PAS, pulmonary adaption disturbance P 22.1, RDS, respiratory distress syndrome P22.0, MAS meconium aspiration syndrome P24.0, PPHN, Persistent Pulmonary Hypertension P29.3B, or PTX, Pneumothorax P25.1.
Time frame
One week after birth4
Hypoxic-ischemic encephalopathy as a diagnosis after birth
Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoxic-ischemic encephalopathy grade I-III, P91.6A, B, C, or X.
Time frame
One week after birthOther outcomes
1
Neonatal outcomes - breathing
After birth (data registered on the resuscitation chart or imported from monitor equipment): Initiation and establishment of breathing (Minutes and seconds)
Time frame
Birth to one hour2
Neonatal outcomes - temperature
After birth (data registered on the resuscitation chart, source data sheet or imported from monitor equipment): Temperature (degrees Celsius)
Time frame
Birth to six hours3
Neonatal outcomes - interventions
After birth (data registered on the resuscitation chart or imported from monitor equipment): Rate of Interventions (e.g. ventilation, intubation, chest compressions) noted on the resuscitation chart
Time frame
Birth to one hour4
Neonatal outcomes - heart rate
After birth (data registered on the resuscitation chart or imported from monitor equipment): Data from Heart rate and Oxygen saturation monitoring Unit of measure: Heart rate
Time frame
Birth to 24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov