Clinical trial NCT06405867: The Importance of Delayed Cord Clamping
Official title: The Importance of Delayed Cord Clamping: do we Know
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn; Vitality
Iron Deficiency Anemia
Keywords: Delayed cord clamping
hypothermia
polycythemia
iron deficiency anemia
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 316
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Iron deficiency anemia
timeFrame: 4 months
measure: Polycythemia and indirect hyperbilirubinemia
timeFrame: 4 months
Secondary outcomes:
measure: Postpartum hemorrhage
timeFrame: 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Goztepe Prof Dr. Suleyman Yalcın City Hospital
state: N/A (n/a)
Study officials:
affiliation: İstanbul medeniyet faculty
name: Fahri Ovalı, Prof
role: STUDY_CHAIR
References:
citation: 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.