Timing of Umbilical Cord Clamping in Preterm Neonates

August 15, 2023 updated by: Fatma Zaghloul, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12519
        • Faculty of nursinf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (clamping at 30 seconds)
Umbilical cord clamping at 30 seconds
Other: Group B
Umbilical cord clamping at 30 seconds
Experimental: Group clamping at 60 seconds
Umbilical cord clamping at 60 seconds
Other: Group C
Umbilical cord clamping at 60 seconds
Experimental: Group clamping at 90 seconds
Umbilical cord clamping at 90 seconds
Other: Group D
Umbilical cord clamping at 90 seconds
Active Comparator: Group clamping immediately
Umbilical cord clamping immediately after birth (5 second)
Other: Group A
Umbilical cord clamping immediately after birth (5 second)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal APGAR score
Time Frame: 1st, 5th and 10th minutes of life
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
neonatal vital signs
Time Frame: 1st,6th,12th, 24th, and 48th hours
respiration
1st,6th,12th, 24th, and 48th hours
neonatal vital signs
Time Frame: 1st,6th,12th, 24th, and 48th hours
pulse
1st,6th,12th, 24th, and 48th hours
neonatal vital signs
Time Frame: 1st,6th,12th, 24th, and 48th hours
temperature
1st,6th,12th, 24th, and 48th hours
neonatal hemoglobin
Time Frame: 1st,6th,12th, 24th, and 48th hours
measuring this labs for neonate
1st,6th,12th, 24th, and 48th hours
neonatal hematocrit
Time Frame: 1st,6th,12th, 24th, and 48th hours
measuring this labs for neonate
1st,6th,12th, 24th, and 48th hours
neonatal bilirubin level test
Time Frame: 1st,6th,12th, 24th, and 48th hours
measuring this labs for neonate
1st,6th,12th, 24th, and 48th hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose
Time Frame: 1st,6th,12th, 24th, and 48th hours
measuring this labs for neonate
1st,6th,12th, 24th, and 48th hours
oxygen saturation
Time Frame: 1st,6th,12th, 24th, and 48th hours
measuring this labs for neonate
1st,6th,12th, 24th, and 48th hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Lawahez M. Dwedar, lecturer, Faculty of Nursing
  • Study Chair: Fatma Atta, lecturer, Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2021

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cord Clamping

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study will be shared online

IPD Sharing Time Frame

2 months

IPD Sharing Access Criteria

will be published on magazine

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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