Delayed Versus Immediate Cord Clamping in Preterm Birth (PREM-CORD)

July 8, 2026 updated by: Mohammed Amine HANNACHI, Faculty of Medicine of Tunis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tunisia
    • Tunis Governorate
      • Tunis, Tunis Governorate, Tunisia, 1007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed Umbilical Cord Clamping
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
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.
Experimental: Immediate Umbilical Cord Clamping
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Mortality
Time Frame: Within 7 days of birth (or until hospital discharge, whichever occurs first)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Anemia
Time Frame: Within 24-48 hours of birth and if possible 3 to 4 months after birth
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)
Time Frame: From Birth up to 28 days after birth
Incidence of necrotizing enterocolitis stage ≥ II (Bell's classification) in preterm infants.
From Birth up to 28 days after birth
Intraventricular Hemorrhage (IVH)
Time Frame: Within first 7 days of life
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
Time Frame: From Birth up to 28 days after birth
Duration of admission in neonatal intensive care unit measured in days.
From Birth up to 28 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine of Tunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREM-CORD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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