Delayed Cord ClampingNCT03147846
The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.
A study testing delayed cord clamping and cord milking in people with Delayed Cord Clamping and Umbilical Cord Milking, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial Read more about this study
- Who is it for?
- Ages 24 to 35 weeksHealthy volunteers can take part
- Conditions the study is for
- Delayed Cord Clamping, Umbilical Cord Milking, Preterm Neonates
- What is being tested?
- delayed cord clamping and cord milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Jun 2017to 1 Sep 2019
- 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 24 to 35 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age 24 to 34+6 weeks
Who cannot join
- Category III CTG
- Monochorionic twins
- Significant antepartum hemorrhage
- IUGR or Rh incompatibility
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Armed Forces Hospital of Southern Region
Khamis Mushait, 61961
About this study
Official title: The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial
Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial
Read the detailed description
Placental transfusion either by deferred cord clamping or umbilical cord milking became standard care and recommended management especially in preterm deliveries.1 In average, about 80 ml of blood was found to be transferred to the neoborn by one minute after birth.2 This additional blood can afford extra iron and blood volume giving the benefit of less iron deficiency anemia during the first year of life, less need for blood transfusion, less need for vasopressors and less intraventricular hemorrhage (IVH) by 50%.3 Placental transfusion with different techniques proved safety with no significant risks regarding postpartum hemorrhage, polycythemia, jaundice, Apgar score or admission rates.4 Our study aims to compare delayed cord clamping with umbilical cord milking as the best way for placental transfusion for preterm neonates.
- Being tested
- delayed cord clamping, cord milking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed cord clampingProcedure or surgery
delay of cord clamping for 60 seconds
cord milkingProcedure or surgery
active cord milking 5 times
| Study group | Role | What they receive |
|---|---|---|
| delayed cord clamping | Experimental | Keep the baby at the level or below the placenta for 45-60 seconds before clamping the cord.
Keep the room temperature at 23-25˚C and wrap the baby if possible Receives: Procedure: delayed cord clamping |
| cord milking | Active comparator | Do 4-5 strips from proximal (maternal) end of the cord (as proximal as possible) towards the baby abdomen with thumb and forefinger Wait for 2 seconds between each stripping Keep the baby at the level of placenta Receives: Procedure: cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematological parameters of the premature neonates
first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion
Measured: 12 months
Secondary outcomes (1)
composite neonatal morbidities
incidence of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy, jaundice, sepsis , patent ductus arteriosus, etc
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start8 Jun 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Cord ClampingStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Responsible party
- Principal investigator, Hytham Atia, Zagazig University
- Investigators
- Hytham Atia, MD, Principal investigator, Armed forces hospitals Southern Region KSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147846
- Sponsor's protocol ID
- milking vs delayed clamping
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atia H, Badawie A, Elsaid O, Kashef M, Alhaddad N, Gomaa M. The hematological impact of umbilical cord milking versus delayed cord clamping in premature neonates: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Sep 19;22(1):714. doi: 10.1186/s12884-022-05046-7.
PubMed 36123638
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03147846
- Acronym / sponsor ID
- milking vs delayed clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Armed Forces Hospitals, Southern Region, Saudi Arabia
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 May 2017 (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.
Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial
Detailed description
Placental transfusion either by deferred cord clamping or umbilical cord milking became standard care and recommended management especially in preterm deliveries.1 In average, about 80 ml of blood was found to be transferred to the neoborn by one minute after birth.2 This additional blood can afford extra iron and blood volume giving the benefit of less iron deficiency anemia during the first year of life, less need for blood transfusion, less need for vasopressors and less intraventricular hemorrhage (IVH) by 50%.3 Placental transfusion with different techniques proved safety with no significant risks regarding postpartum hemorrhage, polycythemia, jaundice, Apgar score or admission rates.4 Our study aims to compare delayed cord clamping with umbilical cord milking as the best way for placental transfusion for preterm neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delayed cord clamping | Experimental | Procedure: delayed cord clampingKeep the baby at the level or below the placenta for 45-60 seconds before clamping the cord. Keep the room temperature at 23-25˚C and wrap the baby if possible |
| cord milking | Active comparator | Procedure: cord milkingDo 4-5 strips from proximal (maternal) end of the cord (as proximal as possible) towards the baby abdomen with thumb and forefinger Wait for 2 seconds between each stripping Keep the baby at the level of placenta |
Who may qualify
- Ages
- 24 to 35 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age 24 to 34+6 weeks
Key exclusion criteria (4 listed)
- Category III CTG
- Monochorionic twins
- Significant antepartum hemorrhage
- IUGR or Rh incompatibility
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 clampingdelay of cord clamping for 60 seconds | Procedure or surgery | delayed cord clamping |
| cord milkingactive cord milking 5 times | Procedure or surgery | cord milking |
Primary outcome
hematological parameters of the premature neonates
Time frame: 12 months
first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion
1 secondary outcome
composite neonatal morbidities
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 36123638Atia H, Badawie A, Elsaid O, Kashef M, Alhaddad N, Gomaa M. The hematological impact of umbilical cord milking versus delayed cord clamping in premature neonates: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Sep 19;22(1):714. doi: 10.1186/s12884-022-05046-7.
- Individual participant dataSharing planned: No
Related trials for Delayed Cord Clamping
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
30-Second Versus Pulsation-Based Delayed Cord Clamping in Term Newborns
Umbilical Cord Clamping
Recruiting
Cord Clamping Among Neonates With Congenital Heart Disease
Congenital Heart Disease (CHD)
Enrolling by invitation
The Effect of Different Positions Given to the Newborn During Delayed Cord Clamping on Physiological Indicators and Comfort
Newborn Infant, Newborn Health
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.
Hytham Atia, MD principal investigator
Armed forces hospitals Southern Region KSA
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 cord milking in people with Delayed Cord Clamping and Umbilical Cord Milking, run by Zagazig University at 1 site in Saudi Arabia.
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 4 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: finished, as of the sponsor's last update on 31 Mar 2020. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematological parameters of the premature neonates (time frame: 12 months). 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 NCT03147846, which also lists 1 linked publication.
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 31 Mar 2020.