Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping

Not Applicable

• Conditions: Hematocrit Anemia; Acidosis
• Interventions: Procedure: Umbilical cord clamping at birth.

• Registration Number: NCT04459442
• Lead Sponsor: Policlinico Abano Terme

Brief Summary

The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomisation) comparing early cord clamping (ECC, at 60 seconds) and delayed cord clamping (DCC, at 180 seconds) in 90 cases of 'normal', two-step vaginal deliveries. DCC may result in a higher blood volume in the newborn, facilitating the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental acidosis.

Detailed Description

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable transition from fetal to extrauterine 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 (placental transfusion). The most effective way to manage umbilical cord in in 'natural', 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 ECC vs. DCC) on the placental transfusion, defined by Δ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age, accounting for physiological body weight decrease. Secondary outcome included contemporary estimate of pH in arterial cord blood gas analysis at birth.

Material and methods: This is a randomized clinical trial on the effect of different cord management in newborns by 'natural', 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 Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-07
• Study Start: 2021-02-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16
• Primary Completion: 2021-10-15
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Vaginal delivery

Exclusion Criteria

Cesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed cord clamping	Umbilical cord clamping at birth.	Cord clamping at 180 seconds after birth.
Early cord clamping	Umbilical cord clamping at birth.	Cord clamping at 60 seconds after birth.

Primary Outcome Measures

Name	Time	Method
Placental transfusion.	Second day of life	Placental transfusion defined by delta hematocrit (Htc) from arterial cord blood at birth and capillaryblood at 48 h of age.
Cord blood pH	Second day of life.	pH estimate in arterial cord blood gas analysis

Trial Locations

Locations (2)

Policlinico Abano Terme; 🇮🇹 Abano Terme, Italy

Padua University Hospital; 🇮🇹 Padua, Italy