The Importance of Delayed Cord Clamping

NCT06405867 | Completed

• 1 other identifier: SYNEO-02
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

After birth, the umbilical cord is usually clamped and separated from the placenta within the first 30 seconds. Although the exact time to clamp the umbilical cord is unknown, allowing placental transfusion after birth has many benefits for the newborn. Increased bleeding control, which is reported as a maternal complication, has not been found in studies. Approximately 28ml/kg additional blood volume is transferred to the baby with placental transfusion. The hemodynamics of the newborn are positively affected as the blood volume increases the right ventricular volume and the pulmonary pressure begins to decrease with the first breath. In addition, due to this additional blood volume, stem cells and erythrocytes pass through more. There are studies showing that it reduces iron deficiency that occurs in infants at the 4th month. In our study, we aimed to examine the effect of allowing placental transfusion until cord pulsation stopped and the effect of delayed cord clamping on iron deficiency at the 4th month in babies.

Conditions

Newborn; Vitality; Iron Deficiency Anemia

Keywords

Delayed cord clamping; hypothermia; polycythemia; iron deficiency anemia

Outcome Measures

Primary Outcomes (2)

• Iron deficiency anemia

  In terms of iron deficiency anemia, hb \< 11 g/dl and transferrin saturation \< 15% criteria were taken as basis

  4 months

• Polycythemia and indirect hyperbilirubinemia

  Polycythemia was defined by venous hematocrit above 65%. Hyperbilirubinemia was defined as the nomogram being above the phototherapy threshold value.

  4 months

Secondary Outcomes (1)

• Postpartum hemorrhage

  7 days

Study Arms (1)

Early cord clamping (< 30 sec)

EXPERIMENTAL

Regardless of the type of delivery, a stopwatch was started to determine the clamping time by visualizing the baby's shoulder. No intervention was made to the health personnel who gave birth in the ECC group. Routinely, one clamp was clamped close to the baby's umbilicus and the other on the mother's side, with a distance of approximately 5 cm from the first clamp and cut between the two clamps. Cord clamping time was noted on the case report form

Procedure: delayed cord clamping (> 60 sec)

Interventions

delayed cord clamping (> 60 sec) PROCEDURE

In the DCC group, cord pulse was checked without allowing clamping. Waited until the cord pulse stopped. It was wrapped in a sterile and warm cloth and dried. The cord was clamped when the pulse stopped. The cord clamping time was noted on the case report form. In DCC, the baby was placed on the mother's legs in cesarean section (C/S) births and on the mother's mons pubis region in normal vaginal births. The baby was administered a routine delivery room neonatal resuscitation program (NRP) by the pediatrician. After cord clamping, the baby was handed over to the pediatric team.

Also known as: cord clamping time

Early cord clamping (< 30 sec)

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The healthy babies of healthy mothers (no pre-eclampsia, no diabetes, no prolonged rupture of membranes or signs of infection) term (gestational age ≥ 37 weeks) and no additional abnormality were included in the study.

You may not qualify if:

• Babies who needed resuscitation were excluded from the study

Sponsors & Collaborators

• Goztepe Prof Dr Suleyman Yalcın City Hospital: lead

Study Sites (1)

Goztepe Prof Dr. Suleyman Yalcın City Hospital

Istanbul, N/A (n/a), 34730, Turkey (Türkiye)

Location

Related Publications (1)

• Fenton C, McNinch NL, Bieda A, Dowling D, Damato E. Clinical Outcomes in Preterm Infants Following Institution of a Delayed Umbilical Cord Clamping Practice Change. Adv Neonatal Care. 2018 Jun;18(3):223-231. doi: 10.1097/ANC.0000000000000492.

  PMID: 29794839 RESULT

Related Links

• The Short and Long Term Consequences of Delayed Cord Clamping on Late Pre-Term Infants. International journal of women's health

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Hypothermia; Polycythemia

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fahri Ovalı, Prof

  İstanbul medeniyet faculty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric clinic chief assistant, MD

Model Details: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study.

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2020
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)