Efficacy and safety of delayed cord clamping versus umbilical cord milking in term neonates
| ISRCTN | ISRCTN15174417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15174417 |
| Protocol serial number | 79-15 |
| Sponsor | King Abdulaziz University |
| Funder | King Abdulaziz University of Saudi Arabia |
- Submission date
- 21/08/2016
- Registration date
- 29/08/2016
- Last edited
- 15/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
After birth, blood flow in the umbilical cord usually continues for a few minutes. Additional blood is transferred from the mother to the baby during this time, known as placental transfusion. The ideal time to clamp the cord has been an active research area in the last decade. Delayed cord clamping (DCC) and umbilical cord milking (UCM) allow excess residual cord blood to be transferred to the baby rather than going to waste. Both techniques of handling the umbilical cord at birth have been shown to be feasible, effective and safe. Both UCM and DCC reduce the risk of anemia compared to immediate cord clamping. Iron deficiency anemia, where a lack of iron in the body leads to a reduction in the number of red blood cells, is a common health problem among children, especially in developing countries. The aim of this study is to assess the effectiveness and safety of delayed cord clamping versus umbilical cord milking in full-term babies.
Who can participate?
Mothers giving birth at full term (gestational age over 37 weeks)
What does the study involve?
Mother-infant pairs are randomly allocated to either the UCM or the DCC group. Infants in the UCM group are placed at or below the level of the placenta if delivered vaginally or at the same level as the placenta if delivered by cesarean section, and 20cm of the umbilical cord is actively milked towards the navel three times before clamping the cord. For infants in the DCC group, the umbilical cord is clamped after 60 seconds. All mothers and infants are followed up when the infant is between 8 and 12 weeks of age.
What are the possible benefits and risks of participating?
There won’t be any financial reward for participating in the study. Moreover, there are no anticipated harms from participating in this study based on previous research.
Where is the study run from?
King Abdulaziz University Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
March 2015 to December 2016
Who is funding the study?
King Abdulaziz University Hospital (Saudi Arabia)
Who is the main contact?
Dr Heidi Al-Wassia
halwassia@kau.edu.sa
Contact information
Scientific
Department of Pediatrics
King Abdulaziz University
PO Box 80215
Jeddah
21589
Saudi Arabia
 ORCID ID |
0000-0002-8208-4986 |
|---|---|
| Phone | +966 (0)26401000 ext 20208 |
| halwassia@kau.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre unblinded parallel-arm randomized clinical trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | The efficacy and safety of delayed cord clamping versus umbilical cord milking in term neonates: a randomized clinical trial |
| Study objectives | There is no difference between umbilical cord milking (UCM) and delayed cord clamping (DCC) in ferritin level in infants between 8-12 weeks. |
| Ethics approval(s) | King Abdulaziz University Research Ethics Committee, 25/03/2015, ref: 79-15 |
| Health condition(s) or problem(s) studied | Infantile-onset iron deficiency anemia |
| Intervention | No previous studies are available which have compared these two interventions in term infants. In order to detect a 30% difference in mean ferritin levels between the delayed cord clamping and umbilical cord milking groups at 3 months of age with a power of 80% and a significance level of 0.05, a total sample size of about 120 infants will be required for the study. Assuming that 20% are lost to follow up, we will recruit a total of 150 infants. Mother-infant pairs will be randomly allocated to either umbilical cord milking or delayed cord-clamping group. Allocation will be performed using a computer-generated list prepared by an independent biostatistician. The random numbers will be generated in 1:1 allocation, without stratification. The list will be kept confidential to primary investigators. The allocation codes will be placed in sequentially numbered opaque and sealed envelopes. The envelopes will be kept in or delivery room in a lock and key cabinet and will be the responsibility of the in-charge nurse at delivery room. Infants in the cord milking group will be placed at or below the level of the placenta if delivered vaginally or at the same level as the placenta if delivered by cesarean section, and 20cm of the umbilical cord will be actively milked towards the umbilicus three times before clamping the cord. For those randomized to the delayed cord milking, the umbilical cord will be clamped at 60 seconds. A stopwatch in every delivery room will be used to measure the 60 seconds of delayed cord clamping. Follow up will be between 8 and 12 weeks of age . Some of the infants will have their blood drawn at 2 months of age but if they missed the vaccination time (2 months) we allowed them to come back up to 12 weeks (3 months) of age. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Serum ferritin (ng/ml) at 8-12 weeks of age |
| Key secondary outcome measure(s) |
1. Neonatal outcomes: |
| Completion date | 30/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 150 |
| Total final enrolment | 149 |
| Key inclusion criteria | Anticipated full-term birth at GA > 37 weeks confirmed by US in first trimester or last menstrual period |
| Key exclusion criteria | 1. Multiple pregnancy 2. Placenta Previa and abruption 3. Major congenital or chromosomal abnormality 4. Cord prolapse 5. Ruptured vasa previa 6. Rh sensitization 7. Fetal hydrops 8. Significant vaginal bleeding as assessed by obstetrician 24 h prior to delivery. 9. True umbilical cord knot 10. Suspected perinatal asphyxia 11. Suspected meconium aspiration 12. Fetal anomaly that required immediate resuscitation (diaphragmatic hernia) 13. Maternal infection (human immunodeficiency virus, hepatitis A, B or C) 14. Delivery in emergency room |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 01/10/2016 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/08/2020 | 15/01/2021 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/01/2020: The intention to publish date was changed from 01/07/2019 to 01/07/2020.
25/04/2019: The following changes were made to the trial record:
1. The overall end date was changed from 30/12/2016 to 30/12/2017.
2. The intention to publish date was changed from 30/12/2017 to 01/07/2019.
