The Importance of Delayed Cord Clamping

NCT ID: NCT06405867

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-08-25

Brief Summary

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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

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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.

Conditions

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Newborn; Vitality Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early cord clamping (< 30 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

Group Type EXPERIMENTAL

delayed cord clamping (> 60 sec)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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cord clamping time

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sibel Sevuk Ozumut

pediatric clinic chief assistant, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fahri Ovalı, Prof

Role: STUDY_CHAIR

İstanbul medeniyet faculty

Locations

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Goztepe Prof Dr. Suleyman Yalcın City Hospital

Istanbul, N/A (n/a), Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 29794839 (View on PubMed)

Related Links

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https://doi.org/10.2147/IJWH.S385800

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

Other Identifiers

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SYNEO-02

Identifier Type: -

Identifier Source: org_study_id

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