Umbilical Cord MilkingRRTNCT05551390
Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm
A study testing one-time umbilical cord milking and three-times umbilical cord milking in people with Umbilical Cord Milking, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
To compare the neonatal hemoglobin (Hb) in late preterm between one-time versus three-times of umbilical cord milking (UCM) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Umbilical Cord Milking
- What is being tested?
- one-time umbilical cord milking and three-times umbilical cord milking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2022to 1 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Late preterm pregnant women (34-36+6 week's gestation)
Who cannot join
- placenta accrete
- placenta percreta
- placenta previa
- placental abruption
- congenital anomaly
- hydrops fetalis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm: A Randomized Controlled Trial
To compare the neonatal hemoglobin (Hb) in late preterm between one-time versus three-times of umbilical cord milking (UCM)
Read the detailed description
This was a double-blind randomized controlled trial that performed between May 2021 to March 2022 at the Obstetrics and Gynecology Department of Queen Savang Vadhana Memorial Hospital. Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM. The primary outcome was neonatal Hb level at 48-72 hour after birth.
- Conditions
- Umbilical Cord Milking
- Being tested
- one-time umbilical cord milking, three-times umbilical cord milking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-time umbilical cord milkingOther
Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision.
Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics.
three-times umbilical cord milkingOther
Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision.
Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics.
| Study group | Role | What they receive |
|---|---|---|
| one-time umbilical cord milking | Experimental | Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision.
Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics. Receives: Other: one-time umbilical cord milking |
| three-time umbilical cord milking | Experimental | Before UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision.
Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics. Receives: Other: three-times umbilical cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was neonatal Hb level
neonatal Hb level
Measured: 48-72 hour after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 May 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 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.
- 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
- Sequential
- Model description
- Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM.
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551390
- Sponsor's protocol ID
- 010/2564
- Acronym
- RRT
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of One-time Versus Three-times of Umbilical Cord Milking on Neonatal Hemoglobin in Late Preterm: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05551390
- Acronym / sponsor ID
- RRT / 010/2564
- Conditions
- Umbilical Cord Milking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Sep 2022 (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.
To compare the neonatal hemoglobin (Hb) in late preterm between one-time versus three-times of umbilical cord milking (UCM)
Detailed description
This was a double-blind randomized controlled trial that performed between May 2021 to March 2022 at the Obstetrics and Gynecology Department of Queen Savang Vadhana Memorial Hospital. Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM. The primary outcome was neonatal Hb level at 48-72 hour after birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times UCM.
| Arm | Type | Receives |
|---|---|---|
| one-time umbilical cord milking | Experimental | Other: one-time umbilical cord milkingBefore UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics. |
| three-time umbilical cord milking | Experimental | Other: three-times umbilical cord milkingBefore UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Late preterm pregnant women (34-36+6 week's gestation)
Key exclusion criteria (6 listed)
- placenta accrete
- placenta percreta
- placenta previa
- placental abruption
- congenital anomaly
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 |
|---|---|---|
| one-time umbilical cord milkingBefore UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics. | Other | one-time umbilical cord milking |
| three-times umbilical cord milkingBefore UCM procedures, in the case of vaginal delivery, the maternity doctor or nurse held the newborn below the level of the introitus. In the case of a cesarean section, the surgeon carries the newborn below the level of the incision. Then maternity nurse or doctor swiped blood in length 20 centimeters of umbilical cord into the newborn, according to the number of swipes that assigned, then cutting the umbilical cord by the international standard methods. Newborns after birth were cared for and assessed according to the newborn nursing standards of QSMH in the department of pediatrics. | Other | three-time umbilical cord milking |
Primary outcome
The primary outcome was neonatal Hb level
Time frame: 48-72 hour after birth
neonatal Hb level
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 22 Sep 2022.
- Individual participant dataSharing planned: No
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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 one-time umbilical cord milking and three-times umbilical cord milking in people with Umbilical Cord Milking, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 6 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 22 Sep 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 Thailand. 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?
The primary outcome was neonatal Hb level (time frame: 48-72 hour after birth). 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 22 Sep 2022.