Delayed Cord Clamping in Rhesus Disease of the Newborn

NCT ID: NCT04600674

Last Updated: 2022-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-29

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Rhesus Isoimmunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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delayed cord clamping

DCC performed at 60 sec after birth

Group Type EXPERIMENTAL

Delayed cord clamping

Intervention Type PROCEDURE

DCC performed at 60 sec after birth

early cord clamping

ECC performed at 15 sec after birth

Group Type EXPERIMENTAL

Early cord clamping

Intervention Type PROCEDURE

ECC performed at 15 sec after birth

Interventions

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Delayed cord clamping

DCC performed at 60 sec after birth

Intervention Type PROCEDURE

Early cord clamping

ECC performed at 15 sec after birth

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Reda Abdelmaksoud

M.D. (Lecturer)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramadan A Mahmoud, MD

Role: STUDY_CHAIR

Sohag Faculty of Medicine, Sohag University

Rana A Khashaba, MD

Role: STUDY_CHAIR

Benha Faculty of Medicine, Benha University

Walid M Tawfik, MD

Role: STUDY_CHAIR

Benha Faculty of Medicine, Benha University

Locations

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Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Shaimaa R Abdelmaksoud, MD

Role: CONTACT

01001814411 ext. 002

Facility Contacts

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Shaimaa R Abdelmaksoud, MD

Role: primary

01001814411 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 26908660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30288843 (View on PubMed)

Other Identifiers

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RC 1-10-2020

Identifier Type: -

Identifier Source: org_study_id

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