Delayed Cord Clamping in Rhesus Disease of the Newborn
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedMarch 7, 2022
March 1, 2022
1.6 years
October 19, 2020
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematocrit value
Hematocrit will be measured at 2 hours of life (percent %)
2 hours
Secondary Outcomes (1)
Bilirubin level
24 hours
Study Arms (2)
delayed cord clamping
EXPERIMENTALDCC performed at 60 sec after birth
early cord clamping
EXPERIMENTALECC performed at 15 sec after birth
Interventions
Eligibility Criteria
You may qualify if:
- \- term or preterm infants born to Rh negative mother
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha University Hospital
Banhā, Qalyubia Governorate, 13512, Egypt
Related Publications (2)
Garabedian C, Rakza T, Drumez E, Poleszczuk M, Ghesquiere L, Wibaut B, Depoortere MH, Vaast P, Storme L, Houfflin-Debarge V. Benefits of Delayed Cord Clamping in Red Blood Cell Alloimmunization. Pediatrics. 2016 Mar;137(3):e20153236. doi: 10.1542/peds.2015-3236. Epub 2016 Feb 18.
PMID: 26908660BACKGROUNDVural I, Ozdemir H, Teker G, Yoldemir T, Bilgen H, Ozek E. Delayed cord clamping in term large-for-gestational age infants: A prospective randomised study. J Paediatr Child Health. 2019 May;55(5):555-560. doi: 10.1111/jpc.14242. Epub 2018 Oct 4.
PMID: 30288843BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. (Lecturer)
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
October 29, 2020
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
March 7, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share