Umbilical Cord MilkingNCT05951348
Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
A study testing Delayed cord clamping for 30 seconds in people with Umbilical Cord Milking, run by Alexandria University at 1 site in Egypt.
Trial summary
the study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Umbilical Cord Milking
- What is being tested?
- Delayed cord clamping for 30 seconds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2021to 20 Jun 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- mother's age (20-40) years.
- pregnancy with a healthy singleton
- gestational age of 38-41 0/7 weeks
- uncomplicated pregnancy
Who cannot join
- Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
- Rh-negative mothers. The fetal exclusion criteria
- fetus with evidence of intrauterine growth restriction
- infant with serious congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
the study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the newborn and the bilirubin level after 72 hrs
Read the detailed description
the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that short time can improve the hemoglobin level and prevent anemia in the newborn with improvement of the iron stores for months in infancy without affection on the bilirubin level and the need for phototherapy. This is significant because of the rising rate of cesarean section all over the world make more children are liable for anemia, and by this simple technique it can be prevented.
- Conditions
- Umbilical Cord Milking
- Being tested
- Delayed cord clamping for 30 seconds
- Keywords
- cesarean section, umbilical cord milking, hemoglobin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clamping for 30 secondsProcedure or surgery
Also called Umbilical cord milking
waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds
| Study group | Role | What they receive |
|---|---|---|
| Immediate cord clamping | No intervention | this arm where the patient didn't receive any special maneuver and immediate cord clamping after delivery of the fetus is done |
| Delayed cord clamping | Experimental | this arm where the patient receive a delay in cord clamping for 30 seconds after delivery of the fetus Receives: Procedure: Delayed cord clamping for 30 seconds |
| Umbilical cord milking | Experimental | this arm where the patient receive stripping of the umbilical cord in the direction of the fetus 10 times in a time frame 10-15 seconds after delivery of the fetus Receives: Procedure: Delayed cord clamping for 30 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin level
a blood sample is taken from the umbilical cord of the neonate
Measured: immediately after the intervention
Secondary outcomes (1)
bilirubin level
trans-cutaneous measurement of the bilirubin level
Measured: 72 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start11 Nov 2021
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord MilkingStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951348
- Sponsor's protocol ID
- 0106748
- Status last verified
- May 2023
- First submitted
- 6 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
- ClinicalTrials.gov ID
- NCT05951348
- Acronym / sponsor ID
- 0106748
- Conditions
- Umbilical Cord Milking
- Keywords
- cesarean section, umbilical cord milking, hemoglobin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 19 Jul 2023 (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 study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the newborn and the bilirubin level after 72 hrs
Detailed description
the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that short time can improve the hemoglobin level and prevent anemia in the newborn with improvement of the iron stores for months in infancy without affection on the bilirubin level and the need for phototherapy. This is significant because of the rising rate of cesarean section all over the world make more children are liable for anemia, and by this simple technique it can be prevented.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate cord clamping | No intervention | –this arm where the patient didn't receive any special maneuver and immediate cord clamping after delivery of the fetus is done |
| Delayed cord clamping | Experimental | Procedure: Delayed cord clamping for 30 secondsthis arm where the patient receive a delay in cord clamping for 30 seconds after delivery of the fetus |
| Umbilical cord milking | Experimental | Procedure: Delayed cord clamping for 30 secondsthis arm where the patient receive stripping of the umbilical cord in the direction of the fetus 10 times in a time frame 10-15 seconds after delivery of the fetus |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- mother's age (20-40) years.
- pregnancy with a healthy singleton
- gestational age of 38-41 0/7 weeks
- uncomplicated pregnancy
Key exclusion criteria (4 listed)
- Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
- Rh-negative mothers. The fetal exclusion criteria
- fetus with evidence of intrauterine growth restriction
- infant with serious congenital anomalies.
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 clamping for 30 secondsAlso: Umbilical cord milkingwaiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds | Procedure or surgery | Delayed cord clamping, Umbilical cord milking |
Primary outcome
hemoglobin level
Time frame: immediately after the intervention
a blood sample is taken from the umbilical cord of the neonate
1 secondary outcome
bilirubin level
Time frame: 72 hours after delivery
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 21 Jul 2023.
Related trials for Umbilical Cord Milking
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Recruiting
Delayed Versus Immediate Cord Clamping in Preterm Birth
Preterm Birth Complication, Neonatal Morbidity and Mortality
Recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm
Preterm, Infant Death
Active, not recruiting
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Recruiting
Evaluation of Placental Transfusion Techniques in Prevention of Prematurity Related Complications and Effect on Their Hematological Profile
Premature, Placental Transfusion
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.
The record lists no contact. Use the official record to reach the sponsor.
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 for 30 seconds in people with Umbilical Cord Milking, run by Alexandria 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 4 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 21 Jul 2023. 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?
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?
hemoglobin level (time frame: immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2023.