Clinical trial NCT06000800: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cord Clamping
Keywords: Umbilical cord clamping
Preterm Neonates
Randomized Controlled Trial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: neonatal APGAR score
timeFrame: 1st, 5th and 10th minutes of life
measure: neonatal vital signs
timeFrame: 1st,6th,12th, 24th, and 48th hours
measure: neonatal vital signs
timeFrame: 1st,6th,12th, 24th, and 48th hours
measure: neonatal vital signs
timeFrame: 1st,6th,12th, 24th, and 48th hours
measure: neonatal hemoglobin
timeFrame: 1st,6th,12th, 24th, and 48th hours
measure: neonatal hematocrit
timeFrame: 1st,6th,12th, 24th, and 48th hours
measure: neonatal bilirubin level test
timeFrame: 1st,6th,12th, 24th, and 48th hours
Secondary outcomes:
measure: blood glucose
timeFrame: 1st,6th,12th, 24th, and 48th hours
measure: oxygen saturation
timeFrame: 1st,6th,12th, 24th, and 48th hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of nursinf
Study officials:
affiliation: faculty of nursing
name: Lawahez M. Dwedar, lecturer
role: STUDY_CHAIR
affiliation: faculty of medicine
name: Fatma Atta, lecturer
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.