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Completed

NCT Number: NCT06405867

The Importance of Delayed Cord Clamping

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.

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Key information

Conditions

Newborn; Vitality Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Body Temperature Changes Hematologic Diseases Hemic and Lymphatic Diseases Hypothermia Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Polycythemia Signs and Symptoms

Age range

1 day–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goztepe Prof Dr. Suleyman Yalcın City Hospital

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

About this study

Healthy term newborns who will be born in our gynecology clinic; type of birth, week of gestation, birth weight, cord clamping time, cord blood gas, APGAR score, complete blood count, maternal complete blood count, maternal complications, baby's first body temperature, postnatal day 3 hematocrit and bilirubin level, diet, phototherapy treatment application Measurements will be determined and evaluated in terms of the baby's condition, monthly routine baby follow-up (anthropometric measurements and physical examination), and routine 4th month iron deficiency screening. These measurements and applications will be made by the baby nurse, pediatric assistant and pediatrician who will be present during the birth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • . Babies who needed resuscitation were excluded from the study

Treatment and study plan

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.

Other names: cord clamping time

Primary outcomes

  1. Iron deficiency anemia

    Time frame: 4 months

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

  2. Polycythemia and indirect hyperbilirubinemia

    Time frame: 4 months

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

Secondary outcomes

  1. Postpartum hemorrhage

    Time frame: 7 days

    Postpartum bleeding greater than 500 ml

Sponsors and collaborators

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Other

Registry information

Official study title

The Importance of Delayed Cord Clamping: do we Know

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 9, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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