The Importance of Delayed Cord Clamping

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia; Newborn; Vitality
• Interventions: Procedure: delayed cord clamping (> 60 sec)

• Registration Number: NCT06405867
• Lead Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-08-25
• Study Completion: 2020-08-25
• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early cord clamping (< 30 sec)	delayed cord clamping (> 60 sec)	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

Primary Outcome Measures

Name	Time	Method
Iron deficiency anemia	4 months	In terms of iron deficiency anemia, hb \< 11 g/dl and transferrin saturation \< 15% criteria were taken as basis
Polycythemia and indirect hyperbilirubinemia	4 months	Polycythemia was defined by venous hematocrit above 65%. Hyperbilirubinemia was defined as the nomogram being above the phototherapy threshold value.

Secondary Outcome Measures

Name	Time	Method
Postpartum hemorrhage	7 days	Postpartum bleeding greater than 500 ml

Trial Locations

Locations (1)

Goztepe Prof Dr. Suleyman Yalcın City Hospital; 🇹🇷 Istanbul, N/A (n/a), Turkey