An interventional study of Group B and Group C in Cord Clamping, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
Umbilical cord clamping is an important intervention that routinely done for all neonates afterbirth. yet the optimal timing for this intervention remains controversial
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 4 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Umbilical cord clamping at 30 seconds
Other: Group B
Umbilical cord clamping at 60 seconds
Other: Group C
Umbilical cord clamping at 90 seconds
Other: Group D
Umbilical cord clamping immediately after birth (5 second)
Other: Group A
Umbilical cord clamping at 30 seconds
Umbilical cord clamping at 60 seconds
Umbilical cord clamping at 90 seconds
Umbilical cord clamping immediately after birth (5 second)
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
Time frame: 1st, 5th and 10th minutes of life
neonatal vital signs
respiration
Time frame: 1st,6th,12th, 24th, and 48th hours
neonatal vital signs
pulse
Time frame: 1st,6th,12th, 24th, and 48th hours
neonatal vital signs
temperature
Time frame: 1st,6th,12th, 24th, and 48th hours
neonatal hemoglobin
measuring this labs for neonate
Time frame: 1st,6th,12th, 24th, and 48th hours
neonatal hematocrit
measuring this labs for neonate
Time frame: 1st,6th,12th, 24th, and 48th hours
neonatal bilirubin level test
measuring this labs for neonate
Time frame: 1st,6th,12th, 24th, and 48th hours
blood glucose
measuring this labs for neonate
Time frame: 1st,6th,12th, 24th, and 48th hours
oxygen saturation
measuring this labs for neonate
Time frame: 1st,6th,12th, 24th, and 48th hours
Plan to share: Yes — the study will be shared online
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Cairo University