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Clinical Trials/NCT04463485
NCT04463485CompletedNot Applicable

Impact of Umbilical Cord Clamping Time on Infant Anemia

Mersin University1 site in 1 country65 target enrollmentStarted: December 21, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
65
Locations
1
Primary Endpoint
Haematocrit Values of 4 Month Infants

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Delayed Clamping

Experimental

The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.

Intervention: Delayed Clamping (Procedure)

Early Clamping

No Intervention

No interventions have been assigned.

Outcomes

Primary Outcomes

Haematocrit Values of 4 Month Infants

Time Frame: Infants' 4th month of age

Haematocrit measurement at baby's 4th month of age

Haemoglobin Values of 4 Month Infants

Time Frame: Infants' 4th month of age

Haemoglobin measurement at baby's 4th month of age

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

Neonatal Bilirubin Value at 48th Hours of Life

Time Frame: 48th hours after birth

Bilirubin measurement in capillary blood taken from newborn after birth

Neonatal Haematocrit Value at 48th Hours of Life

Time Frame: 48th hours after birth

Haematocrit measurement in capillary blood taken from newborn after birth

Phototherapy Requirement Rates due to Hyperbilirubinemia

Time Frame: 3 or 14 days of age

Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sevil Güner

Research Assistant

Mersin University

Study Sites (1)

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