Sustained Cord Circulation at Emergency Cesarean Section

NCT06540222 | Recruiting DMC

• 2 other identifiers: SUCCECSDnr 2024-00276-01
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 12

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

Conditions

Asphyxia Neonatorum; Fetal Hypoxia

Keywords

Emergency cesarean section; Management umbilical cord; intact cord resuscitation

Outcome Measures

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.

  At one hour after birth

Secondary Outcomes (7)

• Apgar score at 5 min

  5 minutes

• Apgar score at 10 min

  10 minutes

• Respiratory distress as a diagnosis after birth

  One week after birth

• Hypoxic-ischemic encephalopathy as a diagnosis after birth

  One week after birth

• Hypoglycemia as a diagnosis after birth

  One week after birth

Other Outcomes (14)

• Neonatal outcomes - breathing

  Birth to one hour

• Neonatal outcomes - temperature

  Birth to six hours

• Neonatal outcomes - interventions

  Birth to one hour

Study Arms (2)

Intact cord

EXPERIMENTAL

The neonate will be kept close to the mother with the cord intact. When in need of ventilatory support, the neonatal team will give ventilatory support with an unclamped umbilical cord, following neonatal cardiopulmonary resuscitation guidelines. Cord clamping will be performed after respiration has been established and at the earliest after three minutes and not later than five minutes.

Procedure: Sustained cord (≥ 180 seconds) resuscitation

Standard care

ACTIVE COMPARATOR

Management according to standard care, including immediate cord clamping for neonates requiring ventilatory support. In cases where ventilatory support is not necessary, cord clamping will be performed within 60 seconds of birth, adhering to established clinical guidelines for neonatal management.

Procedure: Routine (< 60 seconds) cord clamping

Interventions

Sustained cord (≥ 180 seconds) resuscitation PROCEDURE

Resuscitation performed in near proximity to the mother with umbilical cord uncut

Also known as: Intact cord resuscitation, Delayed cord clamping

Intact cord

Routine (< 60 seconds) cord clamping PROCEDURE

Resuscitation performed at a designated area after umbilical cord is cut

Also known as: Immediate clamping

Standard care

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead
• Region Stockholm: collaborator

Study Sites (12)

Östra sjukhuset - Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

RECRUITING

Hallands sjukhus, Halmstad

Halmstad, Sweden

RECRUITING

Universitetssjukhuset i Linköping

Linköping, Sweden

RECRUITING

Skånes Universitetssjukhus

Lund, Sweden

RECRUITING

Skånes Universitetssjukhus, Malmö

Malmo, Sweden

RECRUITING

Universitetssjukhuset Örebro

Örebro, Sweden

RECRUITING

BB Stockholm

Stockholm, Sweden

RECRUITING

Danderyds sjukhus

Stockholm, Sweden

RECRUITING

Karolinska Universitetssjukhuset, Huddinge

Stockholm, Sweden

RECRUITING

Karolinska Universitetssjukhuset, Solna

Stockholm, Sweden

RECRUITING

Södersjukhuset - Sachsska barn- och ungdomssjukhuset

Stockholm, Sweden

RECRUITING

Norrlands universitetssjukhus

Umeå, Sweden

RECRUITING

Related Publications (2)

• Ekelof K, Saether E, Andersson O, Svedenkrans J, Linden K. pre-SUCCECS: Lessons learned from implementing resuscitation and stabilisation with an intact cord during caesarean sections - Focus group discussions with implementation teams. Sex Reprod Healthc. 2025 Sep;45:101114. doi: 10.1016/j.srhc.2025.101114. Epub 2025 May 26.

  PMID: 40479951 BACKGROUND

• Alikhani VS, Thies-Lagergren L, Svedenkrans J, Elfvin A, Bolk J, Andersson O. Stabilisation and resuscitation with intact cord circulation is feasible using a wide variety of approaches; a scoping review. Acta Paediatr. 2023 Dec;112(12):2468-2477. doi: 10.1111/apa.16985. Epub 2023 Sep 28.

  PMID: 37767916 BACKGROUND

Related Links

• Homepage of the SUCCECS study (in Swedish)

MeSH Terms

Conditions

Asphyxia Neonatorum; Fetal Hypoxia

Interventions

Resuscitation; Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ola Andersson, MD PhD

  Region Skåne, Lund University

  PRINCIPAL INVESTIGATOR

• Jenny Svedenkrans, MD PhD

  Karolinska University Hospital, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ola Andersson, MD PhD

CONTACT

‭+46 70-966 41 80; ola.andersson@med.lu.se

Jenny Svedenkrans, MD PhD

CONTACT

‭+46 72-469 86 60; jenny.svedenkrans@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, stepped-wedge cluster randomized trial

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 6, 2024
• Study Start: September 8, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2031
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (12)