Preterm Birth
Conditions
Keywords
Timing of Umbilical Cord clamping, Cord Clamp 20 seconds, Cord Clamp 40 seconds, Cord Clamp 60 seconds
Brief 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. 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.
Interventions
OTHERClamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery
None to add
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraventricular Hemorrhage number and severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and volume of red cell transfusion for newborns. | 15 months | 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. |
Countries
United States
Outcome results
None listed