Clinical trial NCT04463485: Impact of Umbilical Cord Clamping Time on Infant Anemia
Official title: Impact of Umbilical Cord Clamping Time on Infant Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Stage of Labor
Healthy
Umbilical Cord Clamping Time
Infant Conditions
Keywords: umbilical cord
clamping
infant
anemia
midwifery
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 65
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Neonatal Haematocrit Value at 48th Hours of Life
timeFrame: 48th hours after birth
measure: Neonatal Bilirubin Value at 48th Hours of Life
timeFrame: 48th hours after birth
measure: Phototherapy Requirement Rates due to Hyperbilirubinemia
timeFrame: 3 or 14 days of age
measure: Haemoglobin Values of 4 Month Infants
timeFrame: Infants' 4th month of age
measure: Haematocrit Values of 4 Month Infants
timeFrame: Infants' 4th month of age
measure: Diagnosis of Anemia Rates of 4 Month Infants
timeFrame: Infants' 4th month of age
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Medical Hospital Obstetric and Gynecology Department
Study officials:
affiliation: Ege University
name: Birsen Saydam
role: STUDY_DIRECTOR
References: