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This study aims to evaluate the effect of meperidine on the length of active phase of labor in nulliparous or multiparous women, who will be randomized into two (control and study) groups. Our hypothesis is that the use of meperidine during active labor has no effect on the duration of labor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meperidine administration group | Active Comparator | Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine (Aldolan; Liba Laboratuarları, Istanbul, Turkey) .Providers and patients were blinded to the contents of the bags until the conclusion of the study. Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. |
|
| plasebo group | Placebo Comparator | Bag B (placebo group), containing 0.5ml of normal saline solution. Providers and patients were blinded to the contents of the bags until the conclusion of the study.Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meperidine | Drug | 0.5 ml meperidine injection intravenously injected in randomly selected patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Duration of Active Phase of Labour | The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor | 24h |
| Measure | Description | Time Frame |
|---|---|---|
| Total Duration of Labour | Total time of delivery of patients who gave birth including the second stage of delivery | 24h |
| Duration of the Second Stage of Labour | The period of time until the birth of the baby, since the patient being followed for delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orhan SAHIN, MD | Ministery of Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof.Dr.Cemil Tascioglu City Hospital | Istanbul | 34384 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21890889 | Result | Leong WL, Sng BL, Sia AT. A comparison between remifentanil and meperidine for labor analgesia: a systematic review. Anesth Analg. 2011 Oct;113(4):818-25. doi: 10.1213/ANE.0b013e3182289fe9. Epub 2011 Sep 2. | |
| 6021289 | Result | Sica-Blanco Y, Rozada H, Remedio MR. Effect of meperidine on uterine contractility during pregnancy and prelabor. Am J Obstet Gynecol. 1967 Apr 15;97(8):1096-100. doi: 10.1016/0002-9378(67)90471-1. No abstract available. |
| Label | URL |
|---|---|
| meperidine,duration of labor,induction of labor | View source |
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A total of 449 patients were included in the study. 199 patients who did not meet the inclusion criteria were excluded from the study. The remaining 250 patients were randomized to the groups.
The study was planned to be carried out between January 2012 and May 2012 in Kanuni Sultan Süleyman training and research hospital(Istanbul-Turkey), gynecology and obstetrics department.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Infusion bags were prepared and labelled as Bag A (meperidine group), containing 25 mg meperidine,0.5ml (Aldolan; Liba Laboratuarları, Istanbul, Turkey) . |
| FG001 | Control Group | Bag B (placebo group), containing 0.5ml of normal saline solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
term pregnancies with active labor
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | 0.5 ml meperidine injection intravenously injected in randomly selected patients |
| BG001 | Plasebo Group | 0.5 ml saline solution injection intravenously injected in randomly selected patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Duration of Active Phase of Labour | The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor | women giving birth at term period | Posted | Mean | Standard Deviation | minutes | 24h |
|
24h
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| emezis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Orhan SAHIN | Prof.Dr.Cemil Tascioglu City Hospital | +90 532 240 00 12 | drorhansahin@gmail.com |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008614 | Meperidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
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Randomized parallel double blind plasebo controlled study
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Both drug provider and patient do not know which drug or placebo was given
| Saline | Drug | 0.5 ml saline solution injection intravenously injected in randomly selected patients |
|
|
| 24h |
| 15507943 | Result | Sosa CG, Balaguer E, Alonso JG, Panizza R, Laborde A, Berrondo C. Meperidine for dystocia during the first stage of labor: A randomized controlled trial. Am J Obstet Gynecol. 2004 Oct;191(4):1212-8. doi: 10.1016/j.ajog.2004.03.017. |
| 16406273 | Result | Sosa CG, Buekens P, Hughes JM, Balaguer E, Sotero G, Panizza R, Piriz H, Alonso JG. Effect of pethidine administered during the first stage of labor on the acid-base status at birth. Eur J Obstet Gynecol Reprod Biol. 2006 Dec;129(2):135-9. doi: 10.1016/j.ejogrb.2005.11.033. Epub 2006 Jan 6. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Of the 250 patients included in the study, 45 patients with cesarean indication were excluded from the study and baseline measurements were made on the remaining patient population. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Plasebo Group |
Bag B (placebo group), containing 0.5ml of normal saline solution. Providers and patients were blinded to the contents of the bags until the conclusion of the study.Meperidine or placebo were administered by intravenous infusion by means of injectors containing 0.5ml of solution. Saline: 0.5 ml saline solution injection intravenously injected in randomly selected patients |
|
|
|
| Secondary | Total Duration of Labour | Total time of delivery of patients who gave birth including the second stage of delivery | Total time of delivery of patients who gave birth including the second stage of delivery | Posted | Mean | Standard Deviation | minutes | 24h |
|
|
|
| Secondary | Duration of the Second Stage of Labour | The period of time until the birth of the baby, since the patient being followed for delivery | duration of the second stage of labour | Posted | Mean | Standard Deviation | minutes | 24h |
|
|
|
| 0 |
| 105 |
| 20 |
| 105 |
| EG001 | Control Group | 0 | 100 | 4 | 100 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |