Improving newborn health after planned cesarean delivery
Pilot Prospective Unblinded Randomized Controlled Study Assessing the Efficacy and Safety of Physiologically Based Cord Clamping Versus Standard Delayed Cord Clamping After Elective Scheduled Cesarean Delivery of Full-term Newborn
This study tests if waiting a little longer to cut the umbilical cord after a planned cesarean delivery can help newborns breathe better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 37 Weeks to 42 Weeks |
| Sex | All |
| Sponsor | Queen Fabiola Children's University Hospital Academic / other |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT06278415 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of physiologically based cord clamping on neonatal outcomes for babies delivered via elective cesarean section. It aims to enhance the transition from fetal to neonatal life by allowing for a delay in cord clamping, which may help reduce respiratory issues in newborns. The study will involve pregnant women scheduled for cesarean delivery at Brugmann University Hospital, focusing on singleton pregnancies at or after 37 weeks gestation. Participants will be monitored for improvements in respiratory health in their newborns following the intervention.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with singleton pregnancies scheduled for elective cesarean delivery at or after 37 weeks gestation.
Not a fit: Patients with fetal anomalies, abnormal placentation, or those requiring emergency cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce respiratory complications in newborns delivered by cesarean section.
How similar studies have performed: Other studies have shown promising results with delayed cord clamping in vaginal deliveries, suggesting potential benefits for cesarean deliveries as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant women followed-up in Brugmann University Hospital will be eligible to participate if: 1. Scheduled for cesarean delivery (business days and daily working hours) 2. Singleton pregnancy 3. Cesarean section scheduled at or after 37 weeks gestational age Exclusion Criteria: 1. Fetal anomalies (congenital malformations, anemia, growth restriction with abnormal Dopplers) 2. Abnormal placentation (placenta previa) 3. Signs of fetal distress necessitating an emergency cesarean section 4. Spontaneous labor before cesarean section 5. Maternal health issue including severe anemia (defined as hemoglobin level \< 7 g/dL), preeclampsia, and bleeding disorders 6. Maternal refusal of the use of blood products. 7. General anesthesia for cesarian section 8. Planned cord blood banking 9. Total language barrier without possibility of translation
Where this trial is running
Brussels and 1 other locations
- CHU Brugmann — Brussels, Belgium (Recruiting)
- Hôpital Universitair Des Enfants Reine Fabiola — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Anna AMORUSO — Huderf
- Study coordinator: Anna AMORUSO
- Email: anna.amoruso@hubruxelles.be
- Phone: +3224773250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.