Sustained Cord Circulation at Emergency Cesarean Section

Not Applicable

Recruiting

• Conditions: Asphyxia Neonatorum; Fetal Hypoxia

• Registration Number: NCT06540222
• Lead Sponsor: Region Skane

Brief Summary

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

Detailed Description

Study Title

Sustained Cord Circulation During Resuscitation of Non-Breathing Neonates Born by Cesarean Section: A Multicenter Randomized Controlled Trial

Primary Objectives:

To compare neonatal outcomes between two different approaches to resuscitation of term neonates born by CS; Intact cord resuscitation versus standard care with immediate cord clamping, and evaluate:

A composite outcome of admission to neonatal care for predefined criteria or death before admission. Predefined criteria include asphyxia at birth, respiratory distress, hypoxic ischemic encephalopathy (HIE) and hypoglycemia. Assessed within one week after birth.

Secondary Objectives: Secondary outcomes will include short and long-term neonatal outcomes, adverse maternal and neonatal outcomes, and caregivers' and staff's experiences.

Study Design: A multicenter, stepped-wedge cluster randomized trial.

Study Population: Singleton neonate born alive, gestational age ≥37 weeks, born by emergency cesarean section, epidural/spinal anesthesia. Pediatric team summoned before birth due to health concerns regarding the neonate.

Intervention: Resuscitation with intact cord circulation during 3-5 minutes. When in need of respiratory support, the neonate will be kept close to the mother with the cord intact and the placenta attached to the uterine wall. The pediatric team will give respiratory support with sustained cord circulation, following Swedish neonatal CPR guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes. Cord clamping will be performed at the latest at 5 minutes.

Control: Resuscitation will be performed after the cord was cut. When in need of respiratory support, the cord will be clamped immediately, and the neonate will be taken to an adjacent place for resuscitation according to Swedish neonatal CPR guidelines. Well neonates will have their cord clamped after 1 minute in accordance with national recommendations.

Power analysis: At a significant level of 0.05, the power to detect the anticipated risk reduction (15%) would be 0.88 (two-sided).

Study Duration 2025-2028

Study Timeline

• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Status Verified: 2025-09
• Study Start: 2025-09-08
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-22
• Primary Completion: 2027-11
• Study Completion: 2031-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• 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.

Exclusion Criteria

• Major congenital malformation that may affect resuscitation or outcome measures.
• Major genetic disorder that may affect resuscitation or outcome measures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite outcome of admission to neonatal care for predefined criteria and death before admission.	At one hour after birth	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.

Secondary Outcome Measures

Name	Time	Method
Apgar score at 5 min	5 minutes	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.
Apgar score at 10 min	10 minutes	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.
Respiratory distress as a diagnosis after birth	One week 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.
Hypoxic-ischemic encephalopathy as a diagnosis after birth	One week 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.
Hypoglycemia as a diagnosis after birth	One week after birth	Having the at least one of the following diagnosis in the Swedish neonatal quality registry: Hypoglycemia, P 70.4A, or B.
Duration of neonatal care	One month	Duration of neonatal care as noted in the Swedish pregnancy register and Swedish neonatal quality registry: Aggregated as day (continuous) and ≥ 2 days, dichotomous
Death after birth but before admission to neonatal unit	One hour after birth	Noted as dead after birth in the Swedish pregnancy register

Trial Locations

Locations (12)

Östra sjukhuset - Sahlgrenska Universitetssjukhuset; 🇸🇪 Gothenburg, Sweden

Hallands sjukhus, Halmstad; 🇸🇪 Halmstad, Sweden

Universitetssjukhuset i Linköping; 🇸🇪 Linköping, Sweden

Skånes Universitetssjukhus; 🇸🇪 Lund, Sweden

Skånes Universitetssjukhus, Malmö; 🇸🇪 Malmo, Sweden

Universitetssjukhuset Örebro; 🇸🇪 Örebro, Sweden

BB Stockholm; 🇸🇪 Stockholm, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Sweden

Karolinska Universitetssjukhuset, Huddinge; 🇸🇪 Stockholm, Sweden

Karolinska Universitetssjukhuset, Solna; 🇸🇪 Stockholm, Sweden

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