Effect of Supine or Prone Position After Caesarean Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01310153
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : March 8, 2011
Information provided by:
Montefiore Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Respiratory Distress Transitory Tachypnea of Newborn Delayed Transition of the Newborn Persistent Pulmonary Hypertension Procedure: prone positioning Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth
Study Start Date : September 2006
Actual Study Completion Date : February 2009

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female

Inclusion Criteria:All women 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; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01310153

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
Principal Investigator: Orna Rosen, MD Montefiore Medical Center Identifier: NCT01310153     History of Changes
Other Study ID Numbers: 06-09-409
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011

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