Cord Clamping Level Above or Below Mother's Perineum (CLAMP)
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|ClinicalTrials.gov Identifier: NCT02659605|
Recruitment Status : Unknown
Verified January 2016 by Pamela Berens, The University of Texas Health Science Center, Houston.
Recruitment status was: Not yet recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pre-term Birth Delayed Cord Clamping||Procedure: Delayed cord clamping above the perineum Procedure: Delayed cord clamping below the perineum||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cord Clamping Level Above or Below Mother's Perineum|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||January 2017|
|Experimental: Delayed cord clamping above the perineum||
Procedure: Delayed cord clamping above the perineum
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.
|Active Comparator: Delayed cord clamping below the perineum||
Procedure: Delayed cord clamping below the perineum
The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
- Hematocrit level [ Time Frame: 24 hours after delivery ]
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): NCT02659605
|Contact: Pamela Berens, MD||(713) 500-6471||Pamela.D.Berens@uth.tmc.edu|
|United States, Texas|
|Children's Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Contact: Pamela Berens, MD 713-500-6471 Pamela.D.Berens@uth.tmc.edu|
|Principal Investigator:||Pamela Berens, MD||The University of Texas Health Science Center, Houston|