- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310153
Effect of Supine or Prone Position After Caesarean Birth
Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Jack D. Weiler Hospital of the Albert Einstein College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Prone Positioning
Newly born infant placed in prone position (face up) for the first 30 60 seconds of life after delivery by Cesarean birth.
|
newborn babies in prone positioning
|
Active Comparator: Supine Positioning
newly born infant placed in supine position (face down) for the first 30 60 seconds of life after delivery by Cesarean birth.
|
newborn babies in supine positioning
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Orna Rosen, MD, Montefiore Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Signs and Symptoms, Respiratory
- Infant, Premature, Diseases
- Hypertension
- Respiratory Distress Syndrome, Newborn
- Respiratory Distress Syndrome
- Hypertension, Pulmonary
- Tachypnea
- Transient Tachypnea of the Newborn
Other Study ID Numbers
- 06-09-409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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