Delayed Cord Clamping in Rhesus Disease of the Newborn

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04600674

Enrollment

Registered

2020-10-23

Start date

2020-10-29

Completion date

2022-07-01

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhesus Isoimmunization

Keywords

Rhesus Disease, Newborn

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

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.

Interventions

PROCEDUREDelayed cord clamping

DCC performed at 60 sec after birth

PROCEDUREEarly cord clamping

ECC performed at 15 sec after birth

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Minutes

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Contacts

Primary ContactShaimaa R Abdelmaksoud, MD

shaimaareda82@gmail.com01001814411

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026