CClinicalTrials.gg
Status unknownNCT04600674Updated Mar 7, 2022

Delayed Cord Clamping in Rhesus Disease of the Newborn

An interventional study of Delayed cord clamping and Early cord clamping in Rhesus Isoimmunization, sponsored by Benha University. Status unknown at 1 site in Egypt. Open to participants aged Up to 1 Minute. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by Benha University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
Up to 1 Minute
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Rhesus Isoimmunization

Keywords

  • Rhesus Disease
  • Newborn
03

In context

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Minute
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • term or preterm infants born to Rh negative mother

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    delayed cord clamping

    DCC performed at 60 sec after birth

    Procedure: Delayed cord clamping

  • Experimental
    early cord clamping

    ECC performed at 15 sec after birth

    Procedure: Early cord clamping

Interventions

  • ProcedureDelayed cord clamping

    DCC performed at 60 sec after birth

  • ProcedureEarly cord clamping

    ECC performed at 15 sec after birth

06

What researchers measure

Primary outcomes

  1. Hematocrit value

    Hematocrit will be measured at 2 hours of life (percent %)

    Time frame: 2 hours

Secondary outcomes

  1. Bilirubin level

    Bilirubin level will be measured at 24 hours of life (mg/dl)

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • Benha University Hospital
    Banhā, Qalubia 13512, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26908660 ↗
  • Vural 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. PubMed 30288843 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04600674
Lead sponsor
Benha University
Responsible party
Shaimaa Reda Abdelmaksoud (M.D. (Lecturer), Benha University) — Principal investigator
First posted
Oct 23, 2020
Start date
Oct 29, 2020
Primary completion
Jun 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Mar 7, 2022

Study contacts

Shaimaa R Abdelmaksoud, MD
Contact
shaimaareda82@gmail.com
01001814411 ext. 002
Ramadan A Mahmoud, MD
study chair · Sohag Faculty of Medicine, Sohag University
Rana A Khashaba, MD
study chair · Benha Faculty of Medicine, Benha University
Walid M Tawfik, MD
study chair · Benha Faculty of Medicine, Benha University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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