Preventive Analgesia in Multiparas Undergoing Induction of Labour
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| First Received Date ICMJE | April 23, 2007 | ||||
| Last Updated Date | December 12, 2007 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Pain scores (VAS) remain 3 or less [ Time Frame: throughout the first stage of labor ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Pain scores (VAS) remain 3 or less throughout the first stage of labor | ||||
| Change History | Complete list of historical versions of study NCT00465231 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preventive Analgesia in Multiparas Undergoing Induction of Labour | ||||
| Official Title ICMJE | Preventive Analgesia in Labour:A Randomised, Placebo-Controlled Study in Multiparas Undergoing Induction of Labour | ||||
| Brief Summary | Our study is about providing a better birthing experience by placing and initiating epidural for labour pain before the contractions start. This concept of prevention of pain before its onset is known as preventive - or preemptive -pain management and is well known in surgical and anaesthetic practice. We believe that the use of preventive epidural analgesia will improve the quality of labour epidurals, increase maternal satisfaction and reduce the stress response to labour and delivery. |
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| Detailed Description | Labour induces a well-documented stress response in both mother and fetus. Pain, anxiety and stress associated with labour result in the activation of the sympathetic nervous system, which increases plasma catecholamine concentrations with a resultant increase in cardiac output, peripheral vascular resistance and eventually, reduction in utero-placental perfusion. One aspect that has not been addressed in the literature is the role of preventive analgesia in labour. We believe that the use of preventive epidural analgesia will improve the quality of labour pain, increase maternal satisfaction and reduce the stress response in labour. The multiparous parturients that are scheduled for elective inductions of labour will be offered preventive epidural analgesia. Upon placing the epidural, patients will receive, in a double blind fashion, one of two possible epidural drug regimens, which are a saline placebo or 0.0625% bupivacaine with 2 micrograms of fentanyl per millilitre. The patient then undergoes routine induction and management of labour. At any point after induction of labour, patients in either group can request analgesia. Upon request for analgesia the standard epidural loading dose and infusion with PCEA is initiated. The primary outcome will be the success of analgesia (Verbal Analogue Scale of 3 or less) during the first stage of labor, from first request of epidural analgesia to full dilatation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | 16 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00465231 | ||||
| Other Study ID Numbers ICMJE | 07-01, 06-0230-A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Jose Carvalho, Mount Sinai Hospital | ||||
| Study Sponsor ICMJE | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||||
| Verification Date | December 2007 | ||||
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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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