Timing of Umbilical Cord Clamping in Preterm Neonates

Study Overview
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Brief Summary
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Umbilical cord clamping is an important intervention that routinely done for all neonates afterbirth. yet the optimal timing for this intervention remains controversial

Detailed Description
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The study was a randomized controlled trial to assess the effect of timing of umbilical cord clamping on preterm neonatal outcome together The study was conducted in Kasr Al Ainy maternity hospital, Cairo university hospitals which provides free obstetrics and gynecology health services including antepartum, intraparturm, postpartum, and neonatal care for both low risk and high-risk pregnant women A total of 80 pregnant women out of 120 meeting the eligibility criteria were randomly pooled using computer-generated random numbers. The 80 randomly recruited ladies were randomly allocated using sealed envelopes to a group from 4 equal groups (group A, B, C, and D) of 20 ladies each. Umbilical cord clamping was performed immediately after birth (5 second) in group A, at 30 seconds in group B, at 60 seconds in group C, and at 90 seconds in group D.The trial was unblinded; where the participants and researchers were aware of the group a participant belonged to. After the study protocol was granted the ethical approval from the research ethical committee of Faculty of Nursing, Cairo University, Egypt, a written informed consent was obtained form mothers of preterm neonate who met the inclusion criteria including the aim, procedure, benefits, and nature of the study .The anonymity and confidentiality of information was assured, and the mothers had the right to withdraw from the study at any time during the study without any effect on the care provided to their preterm neonates. All study subjects were interviewed using a Structured interview questionnaire to obtain full history to assess participants' demographic data such as age, residence, educational level and occupation, past medical and surgical history, and obstetric history such as gravidity, parity, and current pregnancy antenatal care. Immediately after birth, neonates in all groups are held 20 cm below the incision level.For neonates in group A,umbilical cord was clamped and cut immediately after birth (5 second); while, neonates in group B, umbilical cord were clamped and cut at 30 seconds. For neonates in group C, umbilical cord was clamped and cut at 60 seconds. And finally, neonates in group D, umbilical cord were clamped and cut at 90 seconds. After cord clamping, all neonates were subject to routine immediate care. Neonatal data recorded included neonatal characteristic such as gestational age,birth weight and gender.Neonatal condition was assessed and documented immediately after birth through applying APGAR score of neonatal life, birth weight was measured immediately after delivery through birth scale. Vital signs (respiration, pulse & temperature) were measured birth. A pilot study was conducted on 10% of the study subjects. Eight preterm neonates who met the inclusion criteria; the pilot study was carried out to test the clarity of the tool's questions, and time needed to complete the tools. Additionally, to examine the applicability of the study tool, and to identify any difficulties that may arise and need to be handled before data collection. The pilot study revealed that the tools did not require modification. The sample included in the pilot study was excluded from the main study sample. The collected data will be coded and statistically analyzed to obtain mean and standard deviation for quantitative variables and frequencies (number of cases) and relative frequencies (percentages) for categorical variables. Comparisons between groups will bedone using analysis of variance (ANOVA) with multiple comparisons post hoc test in normally distributed quantitative variables while non-parametric Kruskal-Wallis test and Mann-Whitney test will be used for non-normally distributed quantitative variables . For comparing categorical data, Chi square test will be performed.

Official Title
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Timing of Umbilical Cord Clamping in Preterm Neonates: A Randomized Controlled Trial

Conditions
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Cord Clamping

Intervention / Treatment
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* Other: Group B
* Other: Group C
* Other: Group D
* Other: Group A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria healthy pregnant mothers singleton fetuses preterm cesarian delivery Exclusion Criteria: asphyxiated neonates twins mothers with any medical or obstetrical conditions occurring intrapartum such as hemorrhage, or eclampsia.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial was used to fulfill the aim of the study. The randomized control trial (RCT) is a trial in which subjects are randomly assigned to one of two groups: one (the experimental group) receiving the intervention that is being tested, and the other (the comparison group or control group) receiving an alternative treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (clamping at 30 seconds)<br>Umbilical cord clamping at 30 seconds | Other: Group B<br>* Umbilical cord clamping at 30 seconds<br>|
| Experimental: Group clamping at 60 seconds<br>Umbilical cord clamping at 60 seconds | Other: Group C<br>* Umbilical cord clamping at 60 seconds<br>|
| Experimental: Group clamping at 90 seconds<br>Umbilical cord clamping at 90 seconds | Other: Group D<br>* Umbilical cord clamping at 90 seconds<br>|
| Active Comparator: Group clamping immediately<br>Umbilical cord clamping immediately after birth (5 second) | Other: Group A<br>* Umbilical cord clamping immediately after birth (5 second)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal APGAR score | quick test performed at 1 and 5 minutes after birth to determine the physical condition of the newborn. The five categories assessed are heart rate, respiratory effort, muscle tone, reflex irritability, and color ( score from 8-10 means normal) score from 7-4 moderate asphyxia, from 1-3 sever asphyxia | 1st, 5th and 10th minutes of life | 
| neonatal vital signs | respiration | 1st,6th,12th, 24th, and 48th hours | 
| neonatal vital signs | pulse | 1st,6th,12th, 24th, and 48th hours | 
| neonatal vital signs | temperature | 1st,6th,12th, 24th, and 48th hours | 
| neonatal hemoglobin | measuring this labs for neonate | 1st,6th,12th, 24th, and 48th hours | 
| neonatal hematocrit | measuring this labs for neonate | 1st,6th,12th, 24th, and 48th hours | 
| neonatal bilirubin level test | measuring this labs for neonate | 1st,6th,12th, 24th, and 48th hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose | measuring this labs for neonate | 1st,6th,12th, 24th, and 48th hours | 
| oxygen saturation | measuring this labs for neonate | 1st,6th,12th, 24th, and 48th hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical cord clamping, Preterm Neonates, Randomized Controlled Trial