Premature BirthNCT02092103
Delayed Clamping and Milking the Umbilical Cord in Preterm Infants
A study testing Cord Milking in people with Premature Birth, run by TriHealth Inc. at 1 site in United States.
Trial summary
This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth
- What is being tested?
- Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 8 Jul 2018
- 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
- Admitted to Labor \& Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio with expected/possible preterm delivery between 23-34 weeks gestation
- Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or Tri-State Maternal Fetal Medicine
Who cannot join
- Declined to participate
- Known congenital anomalies
- Precipitous delivery preventing completion of the protocol
- Placental abruption around the time of or as indication for delivery
- Mother has uterine rupture
- Non reassuring fetal heart tracing (FHT) immediately prior/leading to delivery
Show all 9Show fewer
- Multiple gestation
- Parvo B19
- Infants known to be at risk of anemia due to isoimmunization (mother has red blood cell antibodies
Trial locations and contacts
1 site in 1 country.
United States1 site
Good Samaritan TriHealth Hospital
Cincinnati, Ohio, 45220
About this study
Official title: Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes
This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.
Read the detailed description
The optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. It has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. Due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. Immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. Directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. In this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. The decision was made not to include immediate cord clamping due to a recent American Congress of Obstetricians and Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.
- Conditions
- Premature Birth
- Being tested
- Cord Milking
- Keywords
- Premature Birth, Umbilical Cord Clamping
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord MilkingProcedure or surgery
See description in cord milking arm.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Clamping | No intervention | The American Congress of Obstetricians and Gynecologists (ACOG) recommends delayed cord clamping for preterm infants. Infants randomized to this group will follow the protocol below: 1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery) 2. Once infant is delivered designated RN starts timer 3. Infant warming bag on delivery table 4. Infant placed into warming bag then wrapped in a towel 5. Assistant to deliver preps cord clamps 6. Registered Nurse (RN) notifies provider at 30 seconds 7. Cord clamped and cut 8. Infant handed off to waiting staff 9. Exceptions: Placental separation, cord stops pulsating, need for immediate resuscitation, all would result in clamping prior to 30 seconds |
| Cord Milking | Experimental | Infants randomized to the cord milking group will follow the protocol below:
1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery)
2. Infant held and the cord is milked from perineum to infant four times
3. Assistant to deliver preps cord clamps
4. Cord clamped and cut
5. Infant handed off to waiting staff Receives: Procedure: Cord Milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin and Hematocrit values (H/H) in NICU
All H/H values in the neonatal intensive care unit (NICU) will be recorded.
Measured: NICU admission to discharge, expected average of 50 days
Secondary outcomes (3)
Neonatal transfusions
The incidence of transfusions between the two groups will be compared.
Measured: Birth to discharge, expected average of 50 days
Necrotizing enterocolitis
The incidence of necrotizing enterocolitis between the two groups will be compared.
Measured: Birth to discharge, expected average of 50 days
Intraventricular hemorrhage
The incidence of intraventricular hemorrhage between the two groups will be compared.
Measured: Birth to discharge, expected average of 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion8 Jul 2018
- Study completion8 Jul 2018
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 Premature BirthStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Smith, MD PhD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092103
- Sponsor's protocol ID
- 13094-14-012
- Status last verified
- Sep 2018
- First submitted
- 13 Mar 2014
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
PubMed 23168790
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT02092103
- Acronym / sponsor ID
- 13094-14-012
- Conditions
- Premature Birth
- Keywords
- Premature Birth, Umbilical Cord Clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Mar 2014
- Primary completion
- 8 Jul 2018 (actual)
- Study completion
- 8 Jul 2018 (actual)
- First posted
- 19 Mar 2014 (estimated)
- 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.
This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.
Detailed description
The optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. It has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. Due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. Immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. Directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. In this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. The decision was made not to include immediate cord clamping due to a recent American Congress of Obstetricians and Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Clamping | No intervention | –The American Congress of Obstetricians and Gynecologists (ACOG) recommends delayed cord clamping for preterm infants. Infants randomized to this group will follow the protocol below: 1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery) 2. Once infant is delivered designated RN starts timer 3. Infant warming bag on delivery table 4. Infant placed into warming bag then wrapped in a towel 5. Assistant to deliver preps cord clamps 6. Registered Nurse (RN) notifies provider at 30 seconds 7. Cord clamped and cut 8. Infant handed off to waiting staff 9. Exceptions: Placental separation, cord stops pulsating, need for immediate resuscitation, all would result in clamping prior to 30 seconds |
| Cord Milking | Experimental | Procedure: Cord MilkingInfants randomized to the cord milking group will follow the protocol below: 1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery) 2. Infant held and the cord is milked from perineum to infant four times 3. Assistant to deliver preps cord clamps 4. Cord clamped and cut 5. Infant handed off to waiting staff |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to Labor \& Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio with expected/possible preterm delivery between 23-34 weeks gestation
- Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or Tri-State Maternal Fetal Medicine
Key exclusion criteria (9 listed)
- Declined to participate
- Known congenital anomalies
- Precipitous delivery preventing completion of the protocol
- Placental abruption around the time of or as indication for delivery
- Mother has uterine rupture
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 |
|---|---|---|
| Cord MilkingSee description in cord milking arm. | Procedure or surgery | Cord Milking |
Primary outcome
Hemoglobin and Hematocrit values (H/H) in NICU
Time frame: NICU admission to discharge, expected average of 50 days
All H/H values in the neonatal intensive care unit (NICU) will be recorded.
3 secondary outcomes
Neonatal transfusions
Time frame: Birth to discharge, expected average of 50 days
Necrotizing enterocolitis
Time frame: Birth to discharge, expected average of 50 days
Intraventricular hemorrhage
Time frame: Birth to discharge, expected average of 50 days
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 28 Dec 2018.
- Background: PubMed 23168790Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
- 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.
Kathleen Smith, MD PhD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cord Milking in people with Premature Birth, run by TriHealth Inc. at 1 site in United States.
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 2 inclusion and 9 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 28 Dec 2018. 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 United States. 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 and Hematocrit values (H/H) in NICU (time frame: NICU admission to discharge, expected average of 50 days). 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 NCT02092103, 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 28 Dec 2018.