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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cord Clamp 20 Seconds After Delivery | Active Comparator | Intervention is cord clamp at 20 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. |
|
| Cord Clamp 60 seconds After Delivery | Active Comparator | Intervention is timing of cord clamp at 60 seconds following vaginal or cesarean delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery | Other | None to add |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
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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
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| Name | Affiliation | Role |
|---|---|---|
| James Martin, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center, Winfred L. Wiser Hospital for Women and Infants | Jackson | Mississippi | 39216 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002585 | Cesarean Section |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| D000091642 | Urogenital Diseases |