Effect of Supine or Prone Position After Caesarean Birth

NCT01310153 | Completed

• 1 other identifier: 06-09-409
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Study Arms (2)

Prone Positioning

ACTIVE COMPARATOR

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

Procedure: prone positioning

Supine Positioning

ACTIVE COMPARATOR

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

Procedure: Supine

Interventions

prone positioning PROCEDURE

newborn babies in prone positioning

Prone Positioning

Supine PROCEDURE

newborn babies in supine positioning

Supine Positioning

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

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

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Dyspnea; Transient Tachypnea of the Newborn

Interventions

Prone Position; Supine Position

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Orna Rosen, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof., Dept of Pediatrics (Neonatology)

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 8, 2011
• Study Start: September 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (1)