Cord Clamping Level Above or Below Mother's Perineum

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-02-28

Brief Summary

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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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Detailed Description

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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

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Pre-term Birth Delayed Cord Clamping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Delayed cord clamping above the perineum

Group Type EXPERIMENTAL

Delayed cord clamping above the perineum

Intervention Type PROCEDURE

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.

Delayed cord clamping below the perineum

Group Type ACTIVE_COMPARATOR

Delayed cord clamping below the perineum

Intervention Type PROCEDURE

The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No