Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

Status Completed

Clinical Trial Summary

The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.

Clinical Trial Description

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during natural 'two-step' delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values and placental transfusion. The most effective way to manage umbilical cord in in 'two-step' delivery remains to be established.

Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by 'two-step' delivery. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04351997
Study type	Interventional
Source	Policlinico Abano Terme
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2018
Completion date	September 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03731546` - Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency	N/A
Not yet recruiting	`NCT03668782` - Cord Milking in Elective Cesarean Section
Terminated	`NCT02618499` - Delayed Cord Clamping and Use of Oxytocin	Phase 3
Completed	`NCT04898868` - Association Between Blood Volume, the Interval From Delivery to Cord Clamping, and Number of Umbilical Cord Milking	N/A
Completed	`NCT03916159` - Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants	N/A
Completed	`NCT02827409` - Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.	N/A
Completed	`NCT02478684` - Delayed Cord Clamping in Preterm Neonates	N/A
Not yet recruiting	`NCT03983902` - Placental Transfusion Methods and Stem Cells	N/A
Completed	`NCT01497353` - Placental Transfusion and Cord Clamping	N/A
Active, not recruiting	`NCT02671305` - Delivery Room Assistance With the Placental Circulation Intact	N/A