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| Descriptive Information Fields | |||||
| Brief Title † | Labor Analgesia in the Latent Phrase | ||||
| Official Title † | Labor Analgesia in the Latent Phrase of the First-Stage of Spontaneous Delivery | ||||
| Brief Summary | Painless labor is an essential part in woman's health care. Labor analgesia in the active phrase is in popular use currently. However, parturients are still haunted by the labor delivery pain in the latent phrase up to 7-8 hours, especially for the nulliparas. Therefore, we hypothesized that labor analgesia in the latent phrase of the first delivery stage would provide superior health care for laboring women. In addition, such analgesia technique would not prolong the time of uterine dilation and labor delivering. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Rate of Cesarean delivery [ Time Frame: The time of the end of the labor ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Time of latent phrase [ Time Frame: From the beginning of regular contraction of uterus to the diameter of cervix to 4cm ] [ Designated as safety issue: Yes ] Time of labor [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: Yes ] Overall feeling of satisfaction of analgesia [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: No ] Side effects [ Time Frame: From the beginning of regular contraction of uterus to the end of the labor ] [ Designated as safety issue: Yes ] VAS pain intensity [ Time Frame: From the intinition of analgesia to the cervical dilation >4cm ] [ Designated as safety issue: Yes ] Instrumental delivery [ Time Frame: The end of the time of the labor ] [ Designated as safety issue: Yes ] Oxytocin infusion rate [ Time Frame: During the whole period of laboring ] [ Designated as safety issue: Yes ] Neonatal Apgar scores [ Time Frame: 1st min, 5th min, 10th min and 20th min ] [ Designated as safety issue: Yes ] Umbilical gas measurement [ Time Frame: After delivering of the fetus ] [ Designated as safety issue: Yes ] Maternal oral temperature [ Time Frame: From the initiation of analgesia to the end of the labor ] [ Designated as safety issue: Yes ] Maternal corticosteroids [ Time Frame: 1h before analgesia; 0h of the analgesia; 5min,10min,30min,45min,1h,2h,3h and hourly till the end of the labor ] [ Designated as safety issue: Yes ] |
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| Condition † | Labor Pain | ||||
| Intervention † | Procedure: Active phrase epidural analgesia Procedure: Latent phrase epidural analgesia |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 15000 | ||||
| Start Date † | January 2003 | ||||
| Completion Date | December 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | China | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00647725 | ||||
| Organization ID | NMU-69714-14XS | ||||
| Secondary IDs †† | MCH03552 | ||||
| Study Sponsor † | Nanjing Medical University | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Nanjing Medical University | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 28, 2008 | ||||
| Last Updated Date | March 31, 2008 | ||||
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