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Completed

NCT Number: NCT04463485

Impact of Umbilical Cord Clamping Time on Infant Anemia

This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia.

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Key information

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Medical Hospital Obstetric and Gynecology Department

Izmir, 35100, Turkey (Türkiye)

About this study

This study is an experimental, randomized controlled study. The sample of the study consisted of 65 pregnant women and newborns (intervention=32, control=33) who applied for delivery at Ege University Medical Hospital Gynecology and Obstetrics Clinic at the time of the study. In this study, "Descriptive Data Form of Impact of Umbilical Cord Clamping Time on Infant Anemia" was used as a data collection tool. In the intervention group waited 60 seconds for umbilical cord clamping in the second stage of labor, in the control group the umbilical cord was clamped in the first 15 seconds. For the data of the first stage of the study, the neonatal hematocrit and bilirubin measurements and the need for phototherapy due to hyperbilirubinemia were evaluated 48 hours after birth. In the second stage of the study, data on anaemia screening performed in family medicine at the end of the fourth month of birth were examined. Statistical analysis of the data from the study was performed using IBM SPSS Statistics 25.0 package program. Parametric tests were used for statistical analysis of the data with a normal distribution. The level of statistical significance was determined as p<0.05.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Apply for normal birth
  • Singleton pregnancy and live fetus
  • Cephalic presentation
  • Estimated birth weight between 2500-4000 grams
  • Birth rates <5
  • Women who received iron support during pregnancy
  • Haemoglobin level ≥ 11 gr/dL
  • No systemic disease or pregnancy complication that may pose a risk for postpartum bleeding.
  • Neonates who don't need for resuscitation after birth
  • Babies who did not receive iron supplements up to the 4th month after birth were included.

Exclusion criteria

  • Pregnant women who refuse to participate in the research
  • Neonates who need for resuscitation after birth
  • Babies who receive iron supplements up to the 4th month after birth were excluded.

Treatment and study plan

Delayed Clamping

Procedure

Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.

Primary outcomes

  1. Neonatal Haematocrit Value at 48th Hours of Life

    Time frame: 48th hours after birth

    Haematocrit measurement in capillary blood taken from newborn after birth

  2. Neonatal Bilirubin Value at 48th Hours of Life

    Time frame: 48th hours after birth

    Bilirubin measurement in capillary blood taken from newborn after birth

  3. Phototherapy Requirement Rates due to Hyperbilirubinemia

    Time frame: 3 or 14 days of age

    Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period

  4. Haemoglobin Values of 4 Month Infants

    Time frame: Infants' 4th month of age

    Haemoglobin measurement at baby's 4th month of age

  5. Haematocrit Values of 4 Month Infants

    Time frame: Infants' 4th month of age

    Haematocrit measurement at baby's 4th month of age

  6. Diagnosis of Anemia Rates of 4 Month Infants

    Time frame: Infants' 4th month of age

    Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2020
Registry last updated
Jul 10, 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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