The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion
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|ClinicalTrials.gov Identifier: NCT02625688|
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : March 28, 2017
Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of years. Based on published data, numerous neonatal benefits have been suggested such as increased hemoglobin and ferritin levels both at birth and longer term. Available systematic reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other neonatal outcomes including polycythemia and hyperbilirubinemia.
A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a second objective assessed whether the time of cord clamping was associated with an increased risk of polycythemia and hyperbilirubinemia during the first week of life. Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is provided on what hour of life the bilirubin levels were measured exactly.
In this randomized control study the investigators would like to determine if delayed cord clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring phototherapy) in term infants.
|Condition or disease||Intervention/treatment||Phase|
|Jaundice Neonatal||Other: Delayed cord clamping Other: Cord milking Other: Early cord clamping||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion: A Randomized-blinded Controlled Trial|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||December 2016|
Placebo Comparator: Early cord clamping
Cord clamping will be applied after 30 seconds post delivery.
Other: Early cord clamping
We have decided to clamp the cord in the early intervention group at 30 seconds and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.
Active Comparator: Delayed cord clamping
Cord clamping will be applied after 3 minutes post delivery.
Other: Delayed cord clamping
We have decided to delay cord clamping in the intervention group to 3 minutes and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.
Active Comparator: Cord milking
The baby will be placed below the level of the placenta, between the mother's thighs (during a vaginal delivery) or at the side of the mother swaddled in sterile towels (during a caesarian delivery).
Other: Cord milking
If cord milking will be the allocated intervention, the recruiter will supervise the midwife, or obstetrician preforming the procedure, and count out loud the number of times the cord has been milked. During vaginal deliveries midwifes will be asked to maintain the infant at least 10 cm above the uterus until the cord is clamped. In case of caesarian sections the baby will be placed on the mother's laps and swaddled in sterile towels to prevent heat loss.
- The number of patients with hyperbilirubinemia requiring phototherapy or exchange transfusion. [ Time Frame: 14 days of life ]Infants requiring phototherapy or exchange transfusion will be evaluated according to the AAP guidelines. The above evidence based guidelines describe the management of neonatal hyperbilirubinaemia in newborns above 35 weeks of gestation. Serum bilirubin levels will be interpreted according to the baby's age in hours. Physicians assessing the infant and prescribing phototherapy will be blinded to treatment.
- The number of patients with polycythemia defined as a hematocrit > 65%. [ Time Frame: 48-72 hours of life. ]Hematocrit levels peak at about 2 hours of age, and gradually stabilize during the following 12-24 hours. To avoid bias and minimalize the amount of needle pricks we have chosen to combine serum bilirubin and hematological measurements to the minimal amount of samples .
- The number of patients with symptomatic polycythemia (hematocrit > 75%), and non - symptomatic polycythemia (hematocrit >80%). [ Time Frame: 48-72 hours of life ]Symptomatic polycythemia (hematocrit > 75%), non - symptomatic polycythemia (hematocrit >80%) requiring exchange transfusion during the 48-72 hours of life
- The number of patients with symptomatic polycythemia defined as lethargy, plethora, jitteriness, tachycardia, tachypnea [ Time Frame: 48-72 hours of life ]
- The number of patients with congenital anemia [ Time Frame: at birth ]cord Hb <12.5 g/dL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625688
|Department of Neonatology and Neonatal Intensive Care Warsaw Medical University|
|Warsaw, Poland, 00-315|
|Principal Investigator:||Joanna Seliga-Siwecka, MD Phd||Medical University of Warsaw|