Rhesus IsoimmunizationNCT04600674
Delayed Cord Clamping in Rhesus Disease of the Newborn
A study testing Delayed cord clamping and Early cord clamping in people with Rhesus Isoimmunization, run by Benha University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Rhesus Isoimmunization
- What is being tested?
- Delayed cord clamping and Early cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Oct 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- term or preterm infants born to Rh negative mother
Who cannot join
- Infants with Rh negative factor
- major congenital malformation
- fetal hydrops
- short umbilical cord less than 25cm
- nuchal cord
- multiple gestation
Show all 12Show fewer
- unstable maternal hemodynamic condition
- placenta abruption
- placenta previa
- uterine rupture
- denied to participate
- depressed neonates who will require immediate resuscitation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital
Banhā, Qalyubia Governorate, 13512
Shaimaa R Abdelmaksoud, MD, 01001814411 ext. 002, shaimaareda82@gmail.com
About this study
Official title: Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial
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.
- Conditions
- Rhesus Isoimmunization
- Being tested
- Delayed cord clamping, Early cord clamping
- Keywords
- Rhesus Disease, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingProcedure or surgery
DCC performed at 60 sec after birth
Early cord clampingProcedure or surgery
ECC performed at 15 sec after birth
| Study group | Role | What they receive |
|---|---|---|
| delayed cord clamping | Experimental | DCC performed at 60 sec after birth Receives: Procedure: Delayed cord clamping |
| early cord clamping | Experimental | ECC performed at 15 sec after birth Receives: Procedure: Early cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematocrit value
Hematocrit will be measured at 2 hours of life (percent %)
Measured: 2 hours
Secondary outcomes (1)
Bilirubin level
Bilirubin level will be measured at 24 hours of life (mg/dl)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start29 Oct 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhesus IsoimmunizationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Reda Abdelmaksoud, Benha University
- Investigators
- Ramadan A Mahmoud, MD, Study chair, Sohag Faculty of Medicine, Sohag UniversityRana A Khashaba, MD, Study chair, Benha Faculty of Medicine, Benha UniversityWalid M Tawfik, MD, Study chair, Benha Faculty of Medicine, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600674
- Sponsor's protocol ID
- RC 1-10-2020
- Status last verified
- Mar 2022
- First submitted
- 19 Oct 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26908660Vural 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04600674
- Acronym / sponsor ID
- RC 1-10-2020
- Conditions
- Rhesus Isoimmunization
- Keywords
- Rhesus Disease, Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed cord clamping | Experimental | Procedure: Delayed cord clampingDCC performed at 60 sec after birth |
| early cord clamping | Experimental | Procedure: Early cord clampingECC performed at 15 sec after birth |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- term or preterm infants born to Rh negative mother
Key exclusion criteria (12 listed)
- Infants with Rh negative factor
- major congenital malformation
- fetal hydrops
- short umbilical cord less than 25cm
- nuchal cord
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed cord clampingDCC performed at 60 sec after birth | Procedure or surgery | delayed cord clamping |
| Early cord clampingECC performed at 15 sec after birth | Procedure or surgery | early cord clamping |
Primary outcome
Hematocrit value
Time frame: 2 hours
Hematocrit will be measured at 2 hours of life (percent %)
1 secondary outcome
Bilirubin level
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 26908660Garabedian 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.
- Background: PubMed 30288843Vural 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.
- Individual participant dataSharing planned: No
Related trials for Rhesus Isoimmunization
RecruitingPhase 2
Neonatal Outcomes on Direct Fetal Intravenous Immunoglobulin During Intrauterine Transfusion for Rhesus Isoimmunization
Hemolytic Disease of the Newborn, Fetal Anemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping and Early cord clamping in people with Rhesus Isoimmunization, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa R Abdelmaksoud, MD (01001814411 ext. 002, shaimaareda82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematocrit value (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600674, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.