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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

March 4, 2011
March 7, 2011
September 2006
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Complete list of historical versions of study NCT01310153 on ClinicalTrials.gov Archive Site
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Effect of Supine or Prone Position After Caesarean Birth
Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective 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.

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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Respiratory Distress
  • Transitory Tachypnea of Newborn
  • Delayed Transition of the Newborn
  • Persistent Pulmonary Hypertension
Procedure: prone positioning
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2009
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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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Female
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01310153
06-09-409
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Montefiore Medical Center
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Principal Investigator: Orna Rosen, MD Montefiore Medical Center
Montefiore Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP