Effect of Supine or Prone Position After Caesarean Birth

Not Applicable

Completed

• Conditions: Delayed Transition of the Newborn; Transient Tachypnea of the Newborn; Respiratory Distress; Persistent Pulmonary Hypertension
• Interventions: Procedure: prone positioning; Procedure: Supine

• Registration Number: NCT01310153
• Lead Sponsor: 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prone Positioning	prone positioning	Newly born infant placed in prone position (face up) for the first 30 60 seconds of life after delivery by Cesarean birth.
Supine Positioning	Supine	newly born infant placed in supine position (face down) for the first 30 60 seconds of life after delivery by Cesarean birth.

Trial Locations

Locations (1)

Jack D. Weiler Hospital of the Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States