Optimal Timing of Cord Clamping in Preterm Pregnancy Following Vaginal or Cesarean Delivery (CordClamp)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Mississippi Medical Center
Sponsor:
Information provided by (Responsible Party):
James Martin, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01766908
First received: January 9, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Preterm Birth
Other: cord clamp at 20, 40 or 60 seconds

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Timing of Umbilical Cord Clamping After Vaginal or Cesarean Preterm Birth

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Primary Outcome Measures:
  • Intraventricular Hemorrhage number and severity [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence and volume of red cell transfusion for newborns. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cord Clamping at 20 Seconds
Intervention is cord clamp at 20 seconds following vaginal or cesarean delivery rather than immediately at time of birth.
Other: cord clamp at 20, 40 or 60 seconds
None to add
Other Name: Clamping of umbilical cord following either preterm vaginal or cesarean delivery
Active Comparator: Cord Clamping at 40 seconds
Timing of cord clamp at 40 seconds either by vaginal or cesarean delivery.
Other: cord clamp at 20, 40 or 60 seconds
None to add
Other Name: Clamping of umbilical cord following either preterm vaginal or cesarean delivery
Active Comparator: Cord Clamp at 60 seconds
Intervention is timing of cord clamp at 60 seconds either by vaginal or cesarean delivery rather than immediate cord clamping.
Other: cord clamp at 20, 40 or 60 seconds
None to add
Other Name: Clamping of umbilical cord following either preterm vaginal or cesarean delivery

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

18 years old singleton gestation Between 23-37 weeks gestation Able to understand and sign informed consent

Exclusion Criteria:

multiple gestation/ known intrauterine fetal death unable to sign consent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766908

Contacts
Contact: James N Martin, JR, MD 601-984-5358 jnmartin@umc.edu
Contact: Sheila Belk 601-984-5377

Locations
United States, Mississippi
University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants Recruiting
Jackson, Mississippi, United States, 39216
Contact: James Martin, MD    601-984-5377      
Principal Investigator: James Martin, MD         
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: James Martin, MD University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: James Martin, Professor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01766908     History of Changes
Other Study ID Numbers: 2011-0270
Study First Received: January 9, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
Timing of Umbilical Cord clamping
Cord Clamp 20 seconds
Cord Clamp 40 seconds
Cord Clamp 60 seconds

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 20, 2014