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Cord Clamping Level Above or Below Mother's Perineum

Not Applicable
Completed
Conditions
Delayed Cord Clamping
Pre-term Birth
Interventions
Procedure: Delayed cord clamping below the perineum
Procedure: Delayed cord clamping above the perineum
Registration Number
NCT02659605
Lead Sponsor
The University of Texas Health Science Center, Houston
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
103
Inclusion Criteria
  • Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation
Exclusion Criteria
  • Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders
  • Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption
  • Infants who are not anticipated to undergo spontaneous vaginal delivery

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Delayed cord clamping below the perineumDelayed cord clamping below the perineum-
Delayed cord clamping above the perineumDelayed cord clamping above the perineum-
Primary Outcome Measures
NameTimeMethod
Hematocrit Level24 hours after delivery
Secondary Outcome Measures
NameTimeMethod
Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)during the initial hospital stay (1-2 days)
Number of Participants With Infants Who Received Blood Transfusionduring the initial hospital stay (1-2 days)
Number of Participants With Infants Who Received Phototherapyduring the initial hospital stay (1-2 days)
Apgar Score at 1 Minute1 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.

Apgar Score at 5 Minutes5 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.

Trial Locations

Locations (1)

Children's Memorial Hermann Hospital

🇺🇸

Houston, Texas, United States

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