The Importance of Delayed Cord Clamping

Iron Deficiency Anemia Clinical Trial

Official title:

The Importance of Delayed Cord Clamping: do we Know

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06405867
• Other study ID #: SYNEO-02
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 25, 2020

Study information

• Verified date: May 2024
• Source: Goztepe Prof Dr Suleyman Yalcin City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Newborn; Vitality

Intervention

Procedure:
• delayed cord clamping (> 60 sec)
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.

Locations

Country	Name	City	State
Turkey	Goztepe Prof Dr. Suleyman Yalcin City Hospital	Istanbul	N/A (n/a)

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron deficiency anemia	In terms of iron deficiency anemia, hb < 11 g/dl and transferrin saturation < 15% criteria were taken as basis	4 months
Primary	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	Postpartum hemorrhage	Postpartum bleeding greater than 500 ml	7 days

External Links

•   The Short and Long Term Consequences of Delayed Cord Clamping on Late Pre-Term Infants. International journal of women's health
•   Timing of umbilical cord clamping: effect on iron endowment of the newborn and later iron status.