Impact of Umbilical Cord Clamping Time on Infant Anemia
Primary Purpose
Third Stage of Labor, Healthy, Umbilical Cord Clamping Time
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Delayed Clamping
Sponsored by
About this trial
This is an interventional prevention trial for Third Stage of Labor focused on measuring umbilical cord, clamping, infant, anemia, midwifery
Eligibility Criteria
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.
Sites / Locations
- Ege University Medical Hospital Obstetric and Gynecology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Delayed Clamping
Early Clamping
Arm Description
The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.
No interventions have been assigned.
Outcomes
Primary Outcome Measures
Neonatal Haematocrit Value at 48th Hours of Life
Haematocrit measurement in capillary blood taken from newborn after birth
Neonatal Bilirubin Value at 48th Hours of Life
Bilirubin measurement in capillary blood taken from newborn after birth
Phototherapy Requirement Rates due to Hyperbilirubinemia
Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period
Haemoglobin Values of 4 Month Infants
Haemoglobin measurement at baby's 4th month of age
Haematocrit Values of 4 Month Infants
Haematocrit measurement at baby's 4th month of age
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04463485
Brief Title
Impact of Umbilical Cord Clamping Time on Infant Anemia
Official Title
Impact of Umbilical Cord Clamping Time on Infant Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Third Stage of Labor, Healthy, Umbilical Cord Clamping Time, Infant Conditions
Keywords
umbilical cord, clamping, infant, anemia, midwifery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delayed Clamping
Arm Type
Experimental
Arm Description
The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.
Arm Title
Early Clamping
Arm Type
No Intervention
Arm Description
No interventions have been assigned.
Intervention Type
Procedure
Intervention Name(s)
Delayed Clamping
Intervention Description
Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.
Primary Outcome Measure Information:
Title
Neonatal Haematocrit Value at 48th Hours of Life
Description
Haematocrit measurement in capillary blood taken from newborn after birth
Time Frame
48th hours after birth
Title
Neonatal Bilirubin Value at 48th Hours of Life
Description
Bilirubin measurement in capillary blood taken from newborn after birth
Time Frame
48th hours after birth
Title
Phototherapy Requirement Rates due to Hyperbilirubinemia
Description
Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period
Time Frame
3 or 14 days of age
Title
Haemoglobin Values of 4 Month Infants
Description
Haemoglobin measurement at baby's 4th month of age
Time Frame
Infants' 4th month of age
Title
Haematocrit Values of 4 Month Infants
Description
Haematocrit measurement at baby's 4th month of age
Time Frame
Infants' 4th month of age
Title
Diagnosis of Anemia Rates of 4 Month Infants
Description
Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age
Time Frame
Infants' 4th month of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birsen Saydam
Organizational Affiliation
Ege University
Official's Role
Study Director
Facility Information:
Facility Name
Ege University Medical Hospital Obstetric and Gynecology Department
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Learn more about this trial
Impact of Umbilical Cord Clamping Time on Infant Anemia
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