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Effect of Supine or Prone Position After Caesarean Birth

Primary Purpose

Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

prone positioning

Supine

About this trial

This is an interventional prevention trial for Respiratory Distress

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Prone Positioning

Supine Positioning

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01310153

First Posted

March 4, 2011

Last Updated

August 29, 2018

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01310153

Brief Title

Effect of Supine or Prone Position After Caesarean Birth

Official Title

Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montefiore Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prone Positioning

Arm Type

Active Comparator

Arm Description

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

Arm Title

Supine Positioning

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

prone positioning

Intervention Description

newborn babies in prone positioning

Intervention Type

Procedure

Intervention Name(s)

Supine

Intervention Description

newborn babies in supine positioning

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orna Rosen, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

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Effect of Supine or Prone Position After Caesarean Birth

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