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Completed

NCT Number: NCT03549884

Delayed Cord Clamping in Infants Born by Cesarean Section

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life. Cesarean section, especially elective one, reduces the placental transfusion, mainly because of uterine atony. Therefore, during an elective cesarean section umbilical cord management may play a relevant role on blood passage to the neonate and, as consequence, it may affect neonatal hematological values and cardiovascular parameters. The most effective way to manage umbilical cord in in elective cesarean section 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 hematocrit on the second day of life; in addition, we will assess the effect on perinatal and postnatal cardiovascular parameters.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by cesarean sections. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to eithr ECC or DCC group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome will be the hematocrit on day 2 of life. Secondary outcomes will be pre-ductal oxygen saturation (SaO2) and the heart rate (HR) during the first ten minutes after the birth, arterial blood pressures during the first 3 postnatal days and transcutaneous bilirubin (BT) at day 3 after birth.

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Key information

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera di Padova, University of Padova

Padova, 35128, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Elective cesarean section
  • Gestational age > or = 39 weeks
  • No labor
  • Single pregnancy
  • Parental consent; a written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian

Exclusion criteria

  • Emergent or urgent cesarean sections
  • Twin pregnancies
  • Parental refusal to participate to the study
  • Major congenital malformations (such as cardiopathies)
  • Chromosomic abnormalities
  • Fetal hydrops
  • Severe maternal diseases (such as hypertension)
  • Cord abnormalities (length < 20 cm, funicular prolapse, funicular knots)
  • Intrauterine growth restriction (IUGR)

Treatment and study plan

Delayed Cord Clamping

Procedure

Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section

Early Cord Clamping

Procedure

Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section

Primary outcomes

  1. Hematocrit

    Time frame: Day 2 of life

Secondary outcomes

  1. Preductal transcutaneous saturation (TcSaO2)

    Time frame: During the first 10 minutes of life

  2. Heart rate

    Time frame: During the first 10 minutes of life

    (bpm)

  3. Arterial blood pressure

    Time frame: At day 1, 2, 3 of life

    (mmHg)

  4. Total transcutaneous bilirubin

    Time frame: Day 3 of life

    (mg/dl)

  5. Maternal blood losses

    Time frame: At delivery

    ml

  6. Temperature at Normal nursery admission

    Time frame: At the time of normal nursery admission

    Celsius degrees

  7. Time to the first breath

    Time frame: At birth

    seconds

  8. Weight

    Time frame: Day 3 of life

    g

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

Delayed Cord Clamping in Infants Born by Cesarean Section: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 8, 2018
Registry last updated
Apr 7, 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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