Timing of Umbilical Cord Clamping in Preterm Neonates

Cord Clamping Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06000800
• Other study ID #: Cord Clamping
• Status: Completed
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: December 21, 2022

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 21, 2022
• Est. primary completion date: November 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cord Clamping
• Premature Birth

Intervention

Other:
• Group B
Umbilical cord clamping at 30 seconds
• Group C
Umbilical cord clamping at 60 seconds
• Group D
Umbilical cord clamping at 90 seconds
• Group A
Umbilical cord clamping immediately after birth (5 second)

Locations

Country	Name	City	State
Egypt	Faculty of nursinf	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	neonatal vital signs	respiration	1st,6th,12th, 24th, and 48th hours
Primary	neonatal vital signs	pulse	1st,6th,12th, 24th, and 48th hours
Primary	neonatal vital signs	temperature	1st,6th,12th, 24th, and 48th hours
Primary	neonatal hemoglobin	measuring this labs for neonate	1st,6th,12th, 24th, and 48th hours
Primary	neonatal hematocrit	measuring this labs for neonate	1st,6th,12th, 24th, and 48th hours
Primary	neonatal bilirubin level test	measuring this labs for neonate	1st,6th,12th, 24th, and 48th hours
Secondary	blood glucose	measuring this labs for neonate	1st,6th,12th, 24th, and 48th hours
Secondary	oxygen saturation	measuring this labs for neonate	1st,6th,12th, 24th, and 48th hours