Delayed Cord Clamping in Rhesus Disease of the Newborn

March 4, 2022 updated by: Shaimaa Reda Abdelmaksoud, Benha University

Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial

The objective of this clinical trial is to investigate the effects of delayed cord clamping on hyperbilirubinemia, the need for phototherapy, neonatal intensive care (NICU) admission

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will include term or preterm infants born to Rh negative mother.

The enrolled infants will be randomized into two groups:

Group (1) will include infants with delayed cord clamping performed at 60 sec after birth Group (2) will include infants with early cord clamping within 15 seconds.

History and examination The data on the gender, gestational age, birth weight, length, head circumference, 5- minute Apgar scores, presence of jaundice requiring phototherapy or exchange transfusion, need for admission in neonatal intensive care unit, the presence of respiratory distress (RR > 60 breath per minute) ,and length of hospitalization will be recorded.

The enrolled infants will be followed either with their mothers in the nursery or in NICU. Regarding the mothers; maternal age, maternal weight, any diseases, medication, and mode of delivery, and postpartum hemorrhage requiring blood transfusion will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

  • Egypt
    • Qalubia
      • Banhā, Qalubia, Egypt, 13512
        • Recruiting
        • Benha University Hospital
        • Contact:

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

No older than 1 minute (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- term or preterm infants born to Rh negative mother

Exclusion Criteria:

  • Infants with Rh negative factor
  • major congenital malformation
  • fetal hydrops
  • short umbilical cord less than 25cm
  • nuchal cord
  • multiple gestation
  • unstable maternal hemodynamic condition
  • placenta abruption
  • placenta previa
  • uterine rupture
  • denied to participate
  • depressed neonates who will require immediate resuscitation

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: delayed cord clamping
DCC performed at 60 sec after birth
Procedure: Delayed cord clamping
DCC performed at 60 sec after birth
EXPERIMENTAL: early cord clamping
ECC performed at 15 sec after birth
Procedure: Early cord clamping
ECC performed at 15 sec after birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematocrit value
Time Frame: 2 hours
Hematocrit will be measured at 2 hours of life (percent %)
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilirubin level
Time Frame: 24 hours
Bilirubin level will be measured at 24 hours of life (mg/dl)
24 hours

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Study Chair: Ramadan A Mahmoud, MD, Sohag Faculty of Medicine, Sohag University
  • Study Chair: Rana A Khashaba, MD, Benha Faculty of Medicine, Benha University
  • Study Chair: Walid M Tawfik, MD, Benha Faculty of Medicine, Benha University

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)

October 29, 2020

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (ACTUAL)

October 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC 1-10-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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