Preterm BirthCordClampNCT01766908
Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery
A study testing Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery in people with Preterm Birth, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2014
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent
Who cannot join
- multiple gestation/ known intrauterine fetal death unable to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants
Jackson, Mississippi, 39216
About this study
Official title: Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth
This is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. Possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.
Read the detailed description
Intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L\&D unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to keep newborn warm using appropriate measures. Evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of IVH or CP.
- Conditions
- Preterm Birth
- Being tested
- Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
- Keywords
- Timing of Umbilical Cord clamping, Cord Clamp 20 seconds, Cord Clamp 40 seconds, Cord Clamp 60 seconds
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamp cord 20, 40 or 60 seconds following vaginal or cesarean deliveryOther
Also called Clamping of umbilical cord following either preterm vaginal or cesarean delivery
None to add
| Study group | Role | What they receive |
|---|---|---|
| Cord Clamp 20 Seconds After Delivery | Active comparator | Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery Receives: Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery |
| Cord Clamp 40 seconds After Delivery | Active comparator | Timing of cord clamp at 40 seconds following vaginal or cesarean delivery. Receives: Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery |
| Cord Clamp 60 seconds After Delivery | Active comparator | Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery Receives: Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraventricular Hemorrhage number and severity
WE are seeking the length of time to delay cord clamping for various gestational age groups following vaginal or cesarean delivery in order to significantly improve primary outcome.
Measured: 15 months
Secondary outcomes (1)
Incidence and volume of red cell transfusion for newborns.
Benefits will be significantly better with very preterm deliveries compared to those delivered from 29-36 weeks gestation. These benefits will include a lower incidence of transfusion and less frequent/less severe intraventricular hemorrhage in new borns.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Martin, University of Mississippi Medical Center
- Investigators
- James Martin, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766908
- Sponsor's protocol ID
- 2011-0270
- Acronym
- CordClamp
- Status last verified
- Dec 2014
- First submitted
- 9 Jan 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth
- ClinicalTrials.gov ID
- NCT01766908
- Acronym / sponsor ID
- CordClamp / 2011-0270
- Conditions
- Preterm Birth
- Keywords
- Timing of Umbilical Cord clamping, Cord Clamp 20 seconds, Cord Clamp 40 seconds, Cord Clamp 60 seconds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Jan 2013 (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 an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. This study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. Benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. Possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.
Detailed description
Intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. Expectation is 1500 deliveries over 2 year period of time. Randomization upon entry to L\&D unit. Removal from study if resuscitation deemed urgent by newborn staff. Strong effort to keep newborn warm using appropriate measures. Evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of IVH or CP.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cord Clamp 20 Seconds After Delivery | Active comparator | Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean deliveryIntervention is cord clamp at 20 seconds following vaginal or cesarean delivery |
| Cord Clamp 40 seconds After Delivery | Active comparator | Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean deliveryTiming of cord clamp at 40 seconds following vaginal or cesarean delivery. |
| Cord Clamp 60 seconds After Delivery | Active comparator | Other: Clamp cord 20, 40 or 60 seconds following vaginal or cesarean deliveryIntervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent
Key exclusion criteria (1 listed)
- multiple gestation/ known intrauterine fetal death unable to sign consent
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 |
|---|---|---|
| Clamp cord 20, 40 or 60 seconds following vaginal or cesarean deliveryAlso: Clamping of umbilical cord following either preterm vaginal or cesarean deliveryNone to add | Other | Cord Clamp 20 Seconds After Delivery, Cord Clamp 40 seconds After Delivery, Cord Clamp 60 seconds After Delivery |
Primary outcome
Intraventricular Hemorrhage number and severity
Time frame: 15 months
WE are seeking the length of time to delay cord clamping for various gestational age groups following vaginal or cesarean delivery in order to significantly improve primary outcome.
1 secondary outcome
Incidence and volume of red cell transfusion for newborns.
Time frame: 15 months
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 16 Dec 2014.
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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.
James Martin, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery in people with Preterm Birth, run by University of Mississippi Medical Center 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 1 inclusion and 1 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 16 Dec 2014. 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?
Intraventricular Hemorrhage number and severity (time frame: 15 months). 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 16 Dec 2014.