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Effect of Supine or Prone Position After Caesarean Birth

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status

Completed

Conditions

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

Treatments

Procedure: Supine
Procedure: prone positioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01310153
06-09-409

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

65 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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