Delayed Versus Immediate Cord Clamping in Preterm Birth (NCT07699666) | Clinical Trial Compass
RecruitingNot Applicable
Delayed Versus Immediate Cord Clamping in Preterm Birth
Tunisia200 participantsStarted 2025-10-02
Plain-language summary
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
Preterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.
In this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.
The study is conducted in a tertiary maternity center in Tunisia.
Who can participate
Age range
0 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Preterm neonates born at gestational age between 32 and 37 weeks
* Live-born infants delivered in the study center
* Singleton pregnancies
* Parental consent obtained when applicable according to institutional ethical requirements
Exclusion Criteria:
* Major congenital malformations or chromosomal abnormalities
* Need for immediate advanced resuscitation at birth
* Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation
* Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)
* Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing delayed versus immediate cord clamping in preterm births — given my specific situation and how early my baby may be delivered, does the timing of cord clamping actually matter for my baby's survival odds, and is this something my care team already has a standard approach for?
2Since the trial is measuring neonatal mortality as its primary outcome, what do we currently know about how delayed cord clamping affects survival in babies born as early as mine, and would participating in this study change what my baby's delivery team would do in the delivery room?
3I've seen that the trial also involves risks like intraventricular hemorrhage and necrotizing enterocolitis — are these complications my baby is already at risk for given the gestational age, and how would being in this trial affect how those risks are managed?
4Because this is a Phase N/A trial focused on a procedural decision made at the moment of delivery, how much control would I have over which group my baby is assigned to — delayed or immediate clamping — and what happens if an emergency arises during delivery that changes the plan?
5Are there hospitals or birth settings where delayed cord clamping is already standard practice for preterm babies, and if so, should I discuss whether I could receive that care outside of a trial rather than enrolling in this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neonatal Mortality
Timeframe: Within 7 days of birth (or until hospital discharge, whichever occurs first)