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Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Information provided by (Responsible Party):
Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research
ClinicalTrials.gov Identifier:
NCT01555671
First received: March 14, 2012
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
Labor pain is universal and occurs acutely. This is the most painful experience in a woman's life. Pain relief during labor is expected to have positive impact on the progress, outcome and cost of labor. However, it is controversial whether labor analgesia shortens the length of labor and influences progression to cesarean.Labor analgesia can be performed via spinal, epidural or systemic routes (intravenous or intramuscular). Opioid agonists (meperidine, fentanyl etc.) as well are the systemic agents frequently used for labor analgesia.Results of the studies concerning effect of meperidine on the length of labor are controversial.
Many studies have expressed that meperidine has no effect or effect on the progress of labor.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 case and control groups.
| Condition | Intervention | Phase |
|---|---|---|
| Arrested Active Phase of Labor as Antepartum Condition | Drug: Placebo Drug: Meperidine | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Is There Any Effect of Meperidine on the Length of Duration of Labor? A Prospective Randomized Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research:
Primary Outcome Measures:
- The duration of active phase of labour [ Time Frame: 24h ]The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor
Secondary Outcome Measures:
- mode of delivery [ Time Frame: 24h ]The secondary outcome is to determine the mode of delivery either ceasarean or vaginally when meperidine is used
- duration of the second stage of labour [ Time Frame: 24h ]
- need of oxytocin augmentation [ Time Frame: 24h ]
- meconium-stained liquor [ Time Frame: 24h ]
- instrumental delivery rate [ Time Frame: 24h ]
- maternal satisfaction score for the birth process obtained within 24 h of delivery [a visual analog scale (VAS) of 0-10, with higher score denoting greater satisfaction] [ Time Frame: 24h ]
| Estimated Enrollment: | 440 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: meperidine administration group
Infusion bags were prepared and labelled as Bag A (meperidine group), containing 50 mg meperidine (Aldolan; Liba Laboratuarları, Istanbul, Turkey) in 9 mL 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 slow intravenous infusion in about 2 minutes by means of injectors containing 10 mL of solution.
|
Drug: Meperidine
50 mg meperidine injection intramusculer
Other Name: aldolan
|
|
Placebo Comparator: plasebo group
Bag B (placebo group), containing 10 mL 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 slow intravenous infusion in about 2 minutes by means of injectors containing 10 mL of solution.
|
Drug: Placebo
Bag B (placebo group), containing 10 mL of normal saline solution
|
Detailed Description:
- Participant eligibility for the study included gestational age between 34 and 42 weeks, live fetus, cephalic presentation, and were in active phase of labour with well-establish uterine contractions (3 contractions within 10 min) and cervical dilatation between 3 and 5 cm with a partially effaced cervix ( %70 or more ).
- Exclusion criteria are placenta previa, placental abruption, caesarean section or any uterine scarring, abnormal placentation (accreta, increta, or percreta), multiple gestation, fetal macrosomia (≥4000 g), suspicious of cephalopelvic disproportion, meperidine allergy, use any kind of labour induction or augmentation before on admission for delivery in our hospital.
- A Simple randomisation using a random-number table was performed by the investigational pharmacy staff, who took no further part in the study.
- The primary outcome of interest in this study is the labor duration.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- gestational age between 34 and 42 weeks
- live fetus
- cephalic presentation
- in active phase of labour
Exclusion Criteria:
- placenta previa, placental abruption
- caesarean section or any uterine scarring
- multiple gestation
- fetal macrosomia (≥4000 g)
- meperidine allergy
- use any kind of labour induction or augmentation before on admission for delivery in our hospital
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555671
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555671
Contacts
| Contact: Orhan SAHIN, MD | +90 212 473 03 03 ext 1803 | drorhansahin@gmail.com | |
| Contact: Orhan SAHİN | +905056151961 |
Locations
| Turkey | |
| Kanuni Sultan Suleyman Training and Research Hospital | Recruiting |
| Istanbul, Turkey, 34306 | |
| Contact: Orhan SAHIN, MD +90 212 473 03 03 | |
| Principal Investigator: Orhan SAHIN, MD | |
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
| Study Director: | Orhan SAHIN, MD | Ministery of Health |
More Information
Additional Information:
Publications:
| Responsible Party: | Orhan SAHIN, M.D., MD,, Kanuni Sultan Suleyman Training and Research |
| ClinicalTrials.gov Identifier: | NCT01555671 History of Changes |
| Other Study ID Numbers: |
02-11-11-Rev-1 |
| Study First Received: | March 14, 2012 |
| Last Updated: | December 13, 2012 |
Keywords provided by Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research:
|
labor, meperidine, active phase, duration of labor |
Additional relevant MeSH terms:
|
Meperidine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on June 22, 2017