Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
NCT Number: NCT02659605
The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.
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Notify Me18 year and older
Female
Interventional
Not applicable
Houston, Texas, 77030, United States
This study will compare the difference in neonatal hematocrit with delayed cord clamping above vs. below the perineum, in infants who are born via pre-term spontaneous vaginal deliveries that are vigorous at delivery. Delayed cord clamping below the perineum is an accepted clinical practice in obstetrics and gynecology; however, delayed cord clamping above the perineum has not yet been studied in preterm infants. Delayed cord clamping above the perineum will provide the benefit of immediate skin-to-skin contact between the mother and her newborn.
Patients will have delayed cord clamping performed for 60-75 seconds either below the maternal perineum or while the infant is placed on the mother's abdomen. At approximately 24 hours after delivery (at the time of infant heel stick for routine, state-mandated screening tests), a small additional amount of blood will be collected to evaluate newborn hematocrit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
Time frame: 24 hours after delivery
Time frame: during the initial hospital stay (1-2 days)
Time frame: during the initial hospital stay (1-2 days)
Time frame: during the initial hospital stay (1-2 days)
Time frame: 1 minute after birth
The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.
Time frame: 5 minutes after birth
The Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.
The University of Texas Health Science Center, Houston
Other
Acronym: CLAMP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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