Epidural Analgesia Versus IV Meperidine for Labor Pain Control
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|ClinicalTrials.gov Identifier: NCT00296751|
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : July 1, 2010
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Procedure: ECG recording Procedure: Epidural catheter insertion Drug: Intravenous meperidine injection Drug: Epidural Bupivacaine and fentanyl injection||Not Applicable|
Population 60 female during second stage of delivery
- Inclusion criteria : all parturients requiring pain relief will choose between systemic or epidural analgesia.
- Exclusion Criteria: all parturients with cardiac disease, neurological disease, endocrine disease, diabetes, hypertension or any parturients being treated with medications that might effect the cardiovascular autonomic system.
- Method: A 10 minute recording of a 3 lead ECG will be performed during the second stage of the delivery (3-7 CM opening).
the parturient will be lying on her left side for that period.
- 30 minutes after administration of either epidural or systemic Meperidine for pain relief, a second recording of maternal ECG will take place for 10 minutes.
- estimated duration of the procedure about one hour per woman.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epidural Analgesia Versus IV Meperidine for Labor Pain Control. Objective Evaluation of the Pain Intensity Influence on the Autonomic Nervous System.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- Three lead ECG monitoring for 10 minutes will be performed 30 minutes after the administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296751
|Rambam - health care campus|
|Haifa, Israel, 31096|
|Study Director:||Amir Weissman, MD||Rambam Health Care Campus|
|Principal Investigator:||Olga Torchov, MD||Rambam Health Care Campus|