Impact of Umbilical Cord Clamping Time on Infant Anemia

Healthy Clinical Trial

Official title:

Impact of Umbilical Cord Clamping Time on Infant Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463485
• Other study ID #: Delayed Cord Clamping RCT
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2020
• Source: Mersin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Healthy
• Infant Conditions
• Third Stage of Labor
• Umbilical Cord Clamping Time

Intervention

Procedure:
• Delayed Clamping
Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.

Locations

Country	Name	City	State
Turkey	Ege University Medical Hospital Obstetric and Gynecology Department	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Haematocrit Value at 48th Hours of Life	Haematocrit measurement in capillary blood taken from newborn after birth	48th hours after birth
Primary	Neonatal Bilirubin Value at 48th Hours of Life	Bilirubin measurement in capillary blood taken from newborn after birth	48th hours after birth
Primary	Phototherapy Requirement Rates due to Hyperbilirubinemia	Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period	3 or 14 days of age
Primary	Haemoglobin Values of 4 Month Infants	Haemoglobin measurement at baby's 4th month of age	Infants' 4th month of age
Primary	Haematocrit Values of 4 Month Infants	Haematocrit measurement at baby's 4th month of age	Infants' 4th month of age
Primary	Diagnosis of Anemia Rates of 4 Month Infants	Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age	Infants' 4th month of age