Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
difficulty with enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed cord clamping | Experimental | Delayed cord clamping for 30 seconds |
|
| Milking of the cord | Experimental | Milking of the cord 4 times in 10 seconds |
|
| Immediate cord clamping | No Intervention | Immediate cord clamping after delivery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed cord clamping | Procedure | Delay cord clamping for 30 seconds after birth |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Neonatal Event | composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home | up to 24 weeks after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal estimated blood loss | Estimated blood loss at delivery | up to 1 hour after delivery |
| Any grade intraventricular hemorrhage | up to 24 weeks after birth |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rita W Driggers, MD | Washington Hospital Center, Georgetown University Hospital | Principal Investigator |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Milking of the cord |
| Procedure |
Milking of the cord 4 times in 10 seconds |
|
| Severe intraventricular hemorrhage (grade 3 or 4) | up to 24 weeks after birth |
| Periventricular leukomalacia | up to 24 weeks after birth |
| Bronchopulmonary dysplasia | up to 24 weeks after birth |
| Peak transcutaneous and/or serum bilirubin concentrations | up to 24 weeks after birth |
| Phototherapy | Requirement and length of phototherapy | up to 24 weeks after birth |
| Ionotropic support | Requirement and length of ionotropic support | up to 24 weeks after birth |
| Neonatal intesive care unit (NICU) length of stay | up to 24 weeks after birth |
| Sepsis | up to 24 weeks after birth |
| Necrotizing enterocolitis | up to 24 weeks after birth |
| Respiratory distress syndrome | up to 24 weeks after birth |
| Number of blood transfusions while in the neonatal intensive care unit | up to 24 weeks after birth |
| Ventilator time | up to 24 weeks after birth |
| Apgar score <7 at 5 minutes | at 5 minutes after birth |
| Umbilical cord pH < 7.0 | up to 30 minutes after birth |
| Blood pressure on admission to neonatal intensive care unit | at 30 minutes after birth |
| Polycythemia | up to 24 hours of life |
| Hematocrit on admission to neonatal intensive care unit | up to 4 hours after birth |
| Neonatal death | up to 24 weeks of life |
| Length of 3rd stage of labor | Time period between delivery of the baby and delivery of the placenta | up to 1 hour after birth |
| Use of uterotonic agents | up to 1 hour after birth |
| Maternal blood transfusion | up to 5 days after delivery |
| Manual removal of placenta | up to 1 hour after birth |
| Operating time for cesarean delivery | up to 3 hours after birth |
| D000091642 | Urogenital Diseases |