Effect of Supine or Prone Position After Caesarean Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-02-28

Brief Summary

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Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs. supine for the first 30 60 seconds of life after delivery by Caesarean birth.

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Detailed Description

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This study hypothesizes that when the infant is prone they will have postural drainage, better dorsal lung expansion, less vagal response from suctioning and less agitation secondary to the righting reflex.

This study will compare 1033 term babies divided by randomization into two groups prone and supine. During the study, care givers will monitor and record incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.

Conditions

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Respiratory Distress Transient Tachypnea of the Newborn Delayed Transition of the Newborn Persistent Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prone Positioning

Newly born infant placed in prone position (face up) for the first 30 60 seconds of life after delivery by Cesarean birth.

Group Type ACTIVE_COMPARATOR

prone positioning

Intervention Type PROCEDURE

newborn babies in prone positioning

Supine Positioning

newly born infant placed in supine position (face down) for the first 30 60 seconds of life after delivery by Cesarean birth.

Group Type ACTIVE_COMPARATOR

Supine

Intervention Type PROCEDURE

newborn babies in supine positioning

Interventions

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prone positioning

newborn babies in prone positioning

Intervention Type PROCEDURE

Supine

newborn babies in supine positioning

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\* Any woman not in labor who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.

Exclusion Criteria

* any woman with prior rupture of membranes
* diabetes mellitus, gestational diabetes,
* any woman receiving sedation
* using medication such as Demerol, magnesium sulfate or general anesthesia
* any woman who has a known drug history
* any known macrosomia
* known congenital anomalies or meconium stained fluid
* any woman with illnesses such as maternal fever, chorioamnionitis, severe neonatal distress
* any woman with compromised infant at delivery
* oligohydramnios
* history of antenatal steroids.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes