Delayed Cord Clamping in Rhesus Disease of the Newborn

Not Applicable

• Conditions: Rhesus Isoimmunization
• Interventions: Procedure: Early cord clamping; Procedure: Delayed cord clamping

• Registration Number: NCT04600674
• Lead Sponsor: Benha University

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.

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2020-10-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early cord clamping	Early cord clamping	ECC performed at 15 sec after birth
delayed cord clamping	Delayed cord clamping	DCC performed at 60 sec after birth

Primary Outcome Measures

Name	Time	Method
Hematocrit value	2 hours	Hematocrit will be measured at 2 hours of life (percent %)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Benha University Hospital; 🇪🇬 Banhā, Qalubia, Egypt