Delayed Cord Clamping in Rhesus Disease of the Newborn
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: delayed cord clamping DCC performed at 60 sec after birth |
Procedure: Delayed cord clamping
DCC performed at 60 sec after birth
|
| Experimental: early cord clamping ECC performed at 15 sec after birth |
Procedure: Early cord clamping
ECC performed at 15 sec after birth
|
Outcome Measures
Primary Outcome Measures
- Hematocrit value [2 hours]
Hematocrit will be measured at 2 hours of life (percent %)
Secondary Outcome Measures
- Bilirubin level [24 hours]
Bilirubin level will be measured at 24 hours of life (mg/dl)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Benha University Hospital | Banhā | Qalubia | Egypt | 13512 |
Sponsors and Collaborators
- Benha University
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- RC 1-10-2020