Delayed Versus Immediate Cord Clamping in Preterm Birth

NCT07699666 | Recruiting DMC

• 1 other identifier: PREM-CORD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Birth Complication; Neonatal Morbidity and Mortality; Cord Clamping; Delayed Cord Clamping; Anemia; NEC - Necrotizing Enterocolitis; Intraventricular Hemorrhage Neonatal; Respiratory Distress Neonatal

Keywords

Delayed cord clamping; Immediate cord clamping; Preterm infants; Preterm birth; Umbilical cord clamping; Neonatal outcomes; Placental transfusion; Neonatal morbidity; Neonatal mortality; Tunisia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Neonatal Anemia

  Within 24-48 hours of birth and if possible 3 to 4 months after birth

• Necrotizing Enterocolitis (NEC)

  From Birth up to 28 days after birth

• Intraventricular Hemorrhage (IVH)

  Within first 7 days of life

• Length of Neonatal Intensive Care Unit (NICU) Stay

  From Birth up to 28 days after birth

Study Arms (2)

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.

Procedure: Delayed Umbilical Cord Clamping

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.

Procedure: Immediate Umbilical Cord Clamping

Interventions

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.

Delayed Umbilical Cord Clamping

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.

Immediate Umbilical Cord Clamping

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine of Tunis: lead

Study Sites (1)

Maternity and neonatology center of Tunis

Tunis, Tunis Governorate, 1007, Tunisia

RECRUITING

Related Publications (7)

• 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 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.

  PMID: 29097178 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/

  PMID: 26269880 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.

  PMID: 30560107 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.

  PMID: 33773829 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.

  PMID: 26965317 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.

  PMID: 40706055 BACKGROUND

MeSH Terms

Conditions

Anemia; Enterocolitis, Necrotizing; Hyaline Membrane Disease; Premature Birth; Fetofetal Transfusion

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia, Neonatal

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Mohammed Amine MA Hannachi, Assistant professor

CONTACT

+21699696332; mohammedamine.hannachi@fmt.utm.tn

Khaled Neji, Professor

CONTACT

+21651352742; DRKHALEDNEJI21@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Gynecology and Obstetrics

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 13, 2026
• Study Start: October 2, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

TU (1)