- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463485
Impact of Umbilical Cord Clamping Time on Infant Anemia
July 8, 2020 updated by: Sevil Güner, Mersin University
This research was conducted to carry out the effect of umbilical cord clamping time on baby anemia.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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İzmir, Turkey, 35100
- Ege University Medical Hospital Obstetric and Gynecology Department
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Delayed Clamping
The intervention group was waited 60 seconds for umbilical cord clamping in the second stage of labor.
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Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.
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No Intervention: Early Clamping
No interventions have been assigned.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal Haematocrit Value at 48th Hours of Life
Time Frame: 48th hours after birth
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Haematocrit measurement in capillary blood taken from newborn after birth
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48th hours after birth
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Neonatal Bilirubin Value at 48th Hours of Life
Time Frame: 48th hours after birth
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Bilirubin measurement in capillary blood taken from newborn after birth
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48th hours after birth
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Phototherapy Requirement Rates due to Hyperbilirubinemia
Time Frame: 3 or 14 days of age
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Neonatal phototherapy requirement due to hyperbilirubinemia in the postpartum period
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3 or 14 days of age
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Haemoglobin Values of 4 Month Infants
Time Frame: Infants' 4th month of age
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Haemoglobin measurement at baby's 4th month of age
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Infants' 4th month of age
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Haematocrit Values of 4 Month Infants
Time Frame: Infants' 4th month of age
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Haematocrit measurement at baby's 4th month of age
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Infants' 4th month of age
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Diagnosis of Anemia Rates of 4 Month Infants
Time Frame: Infants' 4th month of age
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Screening of the family medicine center, condition of the baby diagnosed with anemia at 4th month of age
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Infants' 4th month of age
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Birsen Saydam, Ege University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2017
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
July 4, 2020
First Submitted That Met QC Criteria
July 4, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Delayed Cord Clamping RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is not a plan to make IPD available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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