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Completed

NCT Number: NCT04351997

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

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.

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Key information

Age range

2 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Abano Terme, Abano Terme, Padua, Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Vaginal delivery Gestational age >37 weeks Natural process of labor

Exclusion criteria

Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

Treatment and study plan

Cord clamping

Procedure

Umbilical cord clamping after delivery.

Primary outcomes

  1. Placental transfusion

    Time frame: Second day of life

    We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age.

Secondary outcomes

  1. Arterial cord blood gas analysis.

    Time frame: Second day of life.

    Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.

  2. Neonatal body weight decrease.

    Time frame: First and second day of life

    Neonatal body weight (Kg) and weight at discharge (Kg)

  3. Blood gases

    Time frame: At birth

    pH (units)

  4. Lactate

    Time frame: At birth

    mmol/L

  5. Glucose

    Time frame: At birth

    mg%

Sponsors and collaborators

Lead sponsor

Policlinico Abano Terme

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2020
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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