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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Umbilical Cord Clamping | Experimental | Delayed umbilical cord clamping is performed in preterm infants according to the study protocol. The umbilical cord is clamped after a predefined delay following birth (at least 30 seconds), allowing continued placental transfusion to the neonate before cord clamping. The intervention is applied immediately after delivery while ensuring neonatal stabilization according to standard clinical practice. |
|
| Immediate Umbilical Cord Clamping | Experimental | Immediate umbilical cord clamping is performed in preterm infants according to standard practice. The umbilical cord is clamped shortly after birth without intentional delay, typically within seconds of delivery, before significant placental transfusion occurs. Neonatal care is provided immediately after clamping according to routine clinical protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed Umbilical Cord Clamping | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Mortality | Death of the neonate occurring within the first 7 days of life or during initial hospitalization in preterm infants allocated to delayed versus immediate umbilical cord clamping. | Within 7 days of birth (or until hospital discharge, whichever occurs first) |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Anemia | Hemoglobin concentration below the predefined threshold for gestational age or need for red blood cell transfusion during the early neonatal period. | Within 24-48 hours of birth and if possible 3 to 4 months after birth |
| Necrotizing Enterocolitis (NEC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Amine MA Hannachi, Assistant professor | Contact | +21699696332 | mohammedamine.hannachi@fmt.utm.tn | |
| Khaled Neji, Professor | Contact | +21651352742 | DRKHALEDNEJI21@GMAIL.COM |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity and neonatology center of Tunis | Recruiting | Tunis | Tunis Governorate | 1007 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35300830 | Background | 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. | |
| 29097178 | Background | 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. |
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This is a parallel-group interventional study with a 1:1 allocation ratio. Preterm neonates are assigned to either delayed or immediate umbilical cord clamping according to the study protocol. Each infant is exposed to only one intervention at birth, and no crossover is permitted. The two groups are followed prospectively to assess early neonatal outcomes, including respiratory adaptation, need for resuscitation, and early morbidity and mortality.
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|
| Immediate Umbilical Cord Clamping | Procedure | 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. |
|
Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants. |
| From Birth up to 28 days after birth |
| Intraventricular Hemorrhage (IVH) | Presence of intraventricular hemorrhage diagnosed by cranial ultrasound, classified according to standard grading system (Papile classification). | Within first 7 days of life |
| Length of Neonatal Intensive Care Unit (NICU) Stay | Duration of admission in neonatal intensive care unit measured in days. | From Birth up to 28 days after birth |
| 26269880 | Background | 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/ |
| 30560107 | Background | 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. |
| 33773829 | Background | 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. |
| 26965317 | Background | 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. |
| 40706055 | Background | 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. |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D020345 | Enterocolitis, Necrotizing |
| D006819 | Hyaline Membrane Disease |
| D047928 | Premature Birth |
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000751 | Anemia, Neonatal |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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