Effect of Supine or Prone Position After Caesarean Birth

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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Key information

Conditions

Respiratory Distress Congenital, Hereditary, and Neonatal Diseases and Abnormalities Delayed Transition of the Newborn Dyspnea Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Pathological Conditions, Signs and Symptoms Persistent Pulmonary Hypertension Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea Transient Tachypnea of the Newborn

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jack D. Weiler Hospital of the Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prone positioning

Procedure

newborn babies in prone positioning

SUPINE

Procedure

newborn babies in supine positioning

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Mar 8, 2011
Registry last updated: Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed