New Options for Preoperative Anesthesia in Intrauterine Needling (NO PAIN)
| Tracking Information | |||||
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| First Received Date ICMJE | November 10, 2009 | ||||
| Last Updated Date | December 7, 2009 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol [ Time Frame: 15-60 minutes ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01013558 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
influence of analgesics (remifentanil) on the fetal stress response [ Time Frame: 15-60 minutes ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | New Options for Preoperative Anesthesia in Intrauterine Needling | ||||
| Official Title ICMJE | NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling | ||||
| Brief Summary | The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
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| 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 | 50 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01013558 | ||||
| Other Study ID Numbers ICMJE | P04.014 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | F.P.H.A. Vandenbussche, MD PhD, Leiden University Medical Center | ||||
| Study Sponsor ICMJE | Leiden University Medical Center | ||||
| Collaborators ICMJE | Leuven University Medical Center | ||||
| Investigators ICMJE |
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| Information Provided By | Leiden University Medical Center | ||||
| Verification Date | November 2009 | ||||
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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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