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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04459442
Enrollment
90
Registered
2020-07-07
Start date
2021-02-01
Completion date
2021-12-30
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acidosis, Hematocrit Anemia

Keywords

Placental transfusion, Natural, two-step delivery, Early cord clamping, Delayed cord clamping

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).

Interventions

PROCEDUREUmbilical cord clamping at birth.

Umbilical cord clamping after delivery.

Sponsors

Policlinico Abano Terme
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Masking description

None (Open Label)

Intervention model description

Parallel Assignment The investigators conducted a randomized controlled trial (parallel group study with 1:1 randomization), comparing early cord clamping (at 60 seconds) and delayed cord clamping (at 180 seconds) in 90 cases of 'normal', two-step vaginal births.

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 2 Days
Healthy volunteers
No

Inclusion criteria

Vaginal delivery

Exclusion criteria

Cesarean delivery

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026