Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06000800
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-08-08
Brief Title:
Timing of Umbilical Cord Clamping in Preterm Neonates
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Timing of Umbilical Cord Clamping in Preterm Neonates A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 DThe 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 levelFor neonates in group Aumbilical 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 agebirth weight and genderNeonatal 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 tools 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
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 DThe 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 levelFor neonates in group Aumbilical 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 agebirth weight and genderNeonatal 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 tools 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None