Effect of Supine or Prone Position After Caesarean Birth
| Tracking Information | |||||
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| First Received Date ICMJE | March 4, 2011 | ||||
| Last Updated Date | March 7, 2011 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01310153 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Supine or Prone Position After Caesarean Birth | ||||
| Official Title ICMJE | Effect of Supine or Prone Position at Delivery on Respiratory Outcomes in Full-Term Infants Following Elective Caesarean Birth | ||||
| 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. The investigators hypothesize 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. The investigators will compare 1033 term babies divided by randomization into two groups prone and supine. The investigators will check for incidence and severity of Respiratory Distress, Use of FiO2 or respiratory support, admissions to NICU. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: prone positioning | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:All women 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; 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. We will also excluded any woman with maternal fever, chorioamnionitis, severe neonatal distress, obviously compromised infant at delivery, oligohydramnios or history of antenatal steroids. - |
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01310153 | ||||
| Other Study ID Numbers ICMJE | 06-09-409 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Montefiore Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Montefiore Medical Center | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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