Clinical Trials Directory

Trials / Completed

CompletedNCT02659605

Cord Clamping Level Above or Below Mother's Perineum

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
103 (actual)
Sponsor
The University of Texas Health Science Center, Houston · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDelayed cord clamping above the perineumAfter 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.
PROCEDUREDelayed cord clamping below the perineumThe infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.

Timeline

Start date
2016-01-01
Primary completion
2017-02-01
Completion
2017-02-01
First posted
2016-01-20
Last updated
2022-02-02
Results posted
2022-02-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02659605. Inclusion in this directory is not an endorsement.