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Timing of Umbilical Cord Clamping in Preterm Neonates

Primary Purpose

Cord Clamping

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group B
Group C
Group D
Group A
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cord Clamping focused on measuring Umbilical cord clamping, Preterm Neonates, Randomized Controlled Trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of nursinf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group (clamping at 30 seconds)

Group clamping at 60 seconds

Group clamping at 90 seconds

Group clamping immediately

Arm Description

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)

Outcomes

Primary Outcome Measures

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
neonatal vital signs
respiration
neonatal vital signs
pulse
neonatal vital signs
temperature
neonatal hemoglobin
measuring this labs for neonate
neonatal hematocrit
measuring this labs for neonate
neonatal bilirubin level test
measuring this labs for neonate

Secondary Outcome Measures

blood glucose
measuring this labs for neonate
oxygen saturation
measuring this labs for neonate

Full Information

First Posted
August 8, 2023
Last Updated
August 15, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06000800
Brief Title
Timing of Umbilical Cord Clamping in Preterm Neonates
Official Title
Timing of Umbilical Cord Clamping in Preterm Neonates: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cord Clamping
Keywords
Umbilical cord clamping, Preterm Neonates, Randomized Controlled Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
The trial was unblinded; where the participants and researchers were aware of the group a participant belonged to
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (clamping at 30 seconds)
Arm Type
Experimental
Arm Description
Umbilical cord clamping at 30 seconds
Arm Title
Group clamping at 60 seconds
Arm Type
Experimental
Arm Description
Umbilical cord clamping at 60 seconds
Arm Title
Group clamping at 90 seconds
Arm Type
Experimental
Arm Description
Umbilical cord clamping at 90 seconds
Arm Title
Group clamping immediately
Arm Type
Active Comparator
Arm Description
Umbilical cord clamping immediately after birth (5 second)
Intervention Type
Other
Intervention Name(s)
Group B
Intervention Description
Umbilical cord clamping at 30 seconds
Intervention Type
Other
Intervention Name(s)
Group C
Intervention Description
Umbilical cord clamping at 60 seconds
Intervention Type
Other
Intervention Name(s)
Group D
Intervention Description
Umbilical cord clamping at 90 seconds
Intervention Type
Other
Intervention Name(s)
Group A
Intervention Description
Umbilical cord clamping immediately after birth (5 second)
Primary Outcome Measure Information:
Title
neonatal APGAR score
Description
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
Title
neonatal vital signs
Description
respiration
Time Frame
1st,6th,12th, 24th, and 48th hours
Title
neonatal vital signs
Description
pulse
Time Frame
1st,6th,12th, 24th, and 48th hours
Title
neonatal vital signs
Description
temperature
Time Frame
1st,6th,12th, 24th, and 48th hours
Title
neonatal hemoglobin
Description
measuring this labs for neonate
Time Frame
1st,6th,12th, 24th, and 48th hours
Title
neonatal hematocrit
Description
measuring this labs for neonate
Time Frame
1st,6th,12th, 24th, and 48th hours
Title
neonatal bilirubin level test
Description
measuring this labs for neonate
Time Frame
1st,6th,12th, 24th, and 48th hours
Secondary Outcome Measure Information:
Title
blood glucose
Description
measuring this labs for neonate
Time Frame
1st,6th,12th, 24th, and 48th hours
Title
oxygen saturation
Description
measuring this labs for neonate
Time Frame
1st,6th,12th, 24th, and 48th hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawahez M. Dwedar, lecturer
Organizational Affiliation
faculty of nursing
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fatma Atta, lecturer
Organizational Affiliation
faculty of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of nursinf
City
Cairo
ZIP/Postal Code
12519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the study will be shared online
IPD Sharing Time Frame
2 months
IPD Sharing Access Criteria
will be published on magazine
Citations:
PubMed Identifier
30159064
Citation
Alzaree F, Elbohoty A, Abdellatif M. Early Versus Delayed Umbilical Cord Clamping on Physiologic Anemia of the Term Newborn Infant. Open Access Maced J Med Sci. 2018 Aug 15;6(8):1399-1404. doi: 10.3889/oamjms.2018.286. eCollection 2018 Aug 20.
Results Reference
background
PubMed Identifier
33214530
Citation
American College of Obstetricians and Gynecologists' Committee on Obstetric Practice. Delayed Umbilical Cord Clamping After Birth: ACOG Committee Opinion, Number 814. Obstet Gynecol. 2020 Dec;136(6):e100-e106. doi: 10.1097/AOG.0000000000004167.
Results Reference
background
PubMed Identifier
28114607
Citation
Kc A, Rana N, Malqvist M, Jarawka Ranneberg L, Subedi K, Andersson O. Effects of Delayed Umbilical Cord Clamping vs Early Clamping on Anemia in Infants at 8 and 12 Months: A Randomized Clinical Trial. JAMA Pediatr. 2017 Mar 1;171(3):264-270. doi: 10.1001/jamapediatrics.2016.3971.
Results Reference
background
PubMed Identifier
34520061
Citation
Bianchi A, Jacobsson B, Mol BW; FIGO Working Group for Preterm Birth. FIGO good practice recommendations on delayed umbilical cord clamping. Int J Gynaecol Obstet. 2021 Oct;155(1):34-36. doi: 10.1002/ijgo.13841.
Results Reference
background
PubMed Identifier
34384773
Citation
Brown BE, Shah PS, Afifi JK, Sherlock RL, Adie MA, Monterrosa LA, Crane JM, Ye XY, El-Naggar WI; Canadian Neonatal Network; Canadian Preterm Birth Network Investigators. Delayed cord clamping in small for gestational age preterm infants. Am J Obstet Gynecol. 2022 Feb;226(2):247.e1-247.e10. doi: 10.1016/j.ajog.2021.08.003. Epub 2021 Aug 9.
Results Reference
background
PubMed Identifier
33081557
Citation
Chiruvolu A, Mallett LH, Govande VP, Raju VN, Hammonds K, Katheria AC. Variations in umbilical cord clamping practices in the United States: a national survey of neonatologists. J Matern Fetal Neonatal Med. 2022 Oct;35(19):3646-3652. doi: 10.1080/14767058.2020.1836150. Epub 2020 Oct 20.
Results Reference
background
PubMed Identifier
32840641
Citation
Deindl P, Diemert A. From structural modalities in perinatal medicine to the frequency of preterm birth. Semin Immunopathol. 2020 Aug;42(4):377-383. doi: 10.1007/s00281-020-00805-0. Epub 2020 Aug 25.
Results Reference
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Timing of Umbilical Cord Clamping in Preterm Neonates

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