Effect of Supine or Prone Position After Caesarean Birth

This study has been completed.
Sponsor:
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01310153
First received: March 4, 2011
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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.

The investigators hypothesize 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.

The investigators will compare 1033 term babies divided by randomization into two groups prone and supine. The investigators will check for incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU.


Condition Intervention Phase
Respiratory Distress
Transitory Tachypnea of Newborn
Delayed Transition of the Newborn
Persistent Pulmonary Hypertension
Procedure: prone positioning
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Study Start Date: September 2006
Study Completion Date: February 2009
  Eligibility

Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:All women not in labor, who are undergoing elective Cesarean birth at term, 37 to 41 completed weeks gestation.

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Exclusion Criteria:any woman with prior rupture of membranes, diabetes mellitus, gestational diabetes, any woman receiving sedation; 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. We will also excluded any woman with maternal fever, chorioamnionitis, severe neonatal distress, obviously compromised infant at delivery, oligohydramnios or history of antenatal steroids.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01310153

Locations
United States, New York
Jack D. Weiler Hospital of the Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Orna Rosen, MD Montefiore Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01310153     History of Changes
Other Study ID Numbers: 06-09-409
Study First Received: March 4, 2011
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Transient Tachypnea of the Newborn
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Distress Syndrome, Newborn
Respiration Disorders
Tachypnea
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014