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Delayed Cord Clamping in Rhesus Disease of the Newborn

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ClinicalTrials.gov Identifier: NCT04600674
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
Shaimaa Reda Abdelmaksoud, Benha University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rhesus Isoimmunization Procedure: Delayed cord clamping Procedure: Early cord clamping Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial
Actual Study Start Date : October 29, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Hematocrit value [ Time Frame: 2 hours ]
    Hematocrit will be measured at 2 hours of life (percent %)


Secondary Outcome Measures :
  1. Bilirubin level [ Time Frame: 24 hours ]
    Bilirubin level will be measured at 24 hours of life (mg/dl)


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600674


Contacts
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Contact: Shaimaa R Abdelmaksoud, MD 01001814411 ext 002 shaimaareda82@gmail.com

Locations
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Egypt
Benha University Hospital Recruiting
Banhā, Qalubia, Egypt, 13512
Contact: Shaimaa R Abdelmaksoud, MD    01001814411 ext 002    shaimaareda82@gmail.com   
Sponsors and Collaborators
Benha University
Investigators
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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
More Information
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Publications:

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Responsible Party: Shaimaa Reda Abdelmaksoud, M.D. (Lecturer), Benha University
ClinicalTrials.gov Identifier: NCT04600674    
Other Study ID Numbers: RC 1-10-2020
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaimaa Reda Abdelmaksoud, Benha University:
Rhesus Disease
Newborn