Delayed Versus Immediate Cord Clamping in Preterm Birth

Официальное название

Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center

Обзор

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.

Вмешательства

• Процедура Delayed Umbilical Cord Clamping
  Delayed umbilical cord clamping is performed in preterm infants by delaying umbilical cord clamping for a predefined duration after birth (at least 30 seconds), allowing continued placental transfusion prior to neonatal separation from the placenta. The procedure is applied immediately after delivery, with neonatal stabilization provided according to standard clinical practice.
• Процедура Immediate Umbilical Cord Clamping
  Immediate umbilical cord clamping is performed in preterm infants by clamping the umbilical cord shortly after birth without intentional delay, typically within seconds following delivery, before significant placental transfusion occurs. Neonatal care is initiated immediately after clamping according to standard practice.

Первичные конечные точки

• Neonatal Mortality [Срок оценки: Within 7 days of birth (or until hospital discharge, whichever occurs first)]

Вторичные конечные точки (4)

• Neonatal Anemia [Срок оценки: Within 24-48 hours of birth and if possible 3 to 4 months after birth]
• Necrotizing Enterocolitis (NEC) [Срок оценки: From Birth up to 28 days after birth]
• Intraventricular Hemorrhage (IVH) [Срок оценки: Within first 7 days of life]
• Length of Neonatal Intensive Care Unit (NICU) Stay [Срок оценки: From Birth up to 28 days after birth]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Tunisia · 1 центр

• Maternity and neonatology center of Tunis — Tunis

Публикации

• McDonald SD, Narvey M, Ehman W, Jain V, Cassell K. Guideline No. 424: Umbilical Cord Management in Preterm and Term Infants. J Obstet Gynaecol Can. 2022 Mar;44(3):313-322.e1. doi: 10.1016/j.jogc.2022.01.007. PMID 35300830
• Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30. PMID 29097178
• Guideline: Delayed Umbilical Cord Clamping for Improved Maternal and Infant Health and Nutrition Outcomes. Geneva: World Health Organization; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK310511/ PMID 26269880
• Ghirardello S, Di Tommaso M, Fiocchi S, Locatelli A, Perrone B, Pratesi S, Saracco P. Italian Recommendations for Placental Transfusion Strategies. Front Pediatr. 2018 Dec 3;6:372. doi: 10.3389/fped.2018.00372. eCollection 2018. PMID 30560107
• Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24. PMID 33773829
• Kc A, Malqvist M, Rana N, Ranneberg LJ, Andersson O. Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal. BMC Pediatr. 2016 Mar 10;16:35. doi: 10.1186/s12887-016-0576-z. PMID 26965317
• ACOG Clinical Practice Update: An Update to Clinical Guidance for Delayed Umbilical Cord Clamping After Birth in Preterm Neonates. Obstet Gynecol. 2025 Jul 24;146(3):442-444. doi: 10.1097/AOG.0000000000006020. PMID 40706055

Идентификаторы

NCT: NCT07699666 · PREM-CORD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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