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Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women

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ClinicalTrials.gov Identifier: NCT01555671
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Arrested Active Phase of Labor as Antepartum Condition Drug: Placebo Drug: Meperidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Is There Any Effect of Meperidine on the Length of Duration of Labor? A Prospective Randomized Controlled Trial.
Study Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: meperidine administration group
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.
Drug: Meperidine
25mg (0.5 ml ) meperidine injection intravenous

Placebo Comparator: 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.
Drug: Placebo
Bag B (placebo group), containing 0.5mL of normal saline solution




Primary Outcome Measures :
  1. 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 :
  1. mode of delivery [ Time Frame: 24h ]
    The secondary outcome is to determine the mode of delivery either ceasarean or vaginally when meperidine is used

  2. duration of the second stage of labour [ Time Frame: 24h ]
  3. need of oxytocin augmentation [ Time Frame: 24h ]
  4. meconium-stained liquor [ Time Frame: 24h ]
  5. instrumental delivery rate [ Time Frame: 24h ]
  6. 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 ]


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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

Information from the National Library of Medicine

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): NCT01555671


Locations
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Turkey
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey, 34306
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Study Director: Orhan SAHIN, MD Ministery of Health

Additional Information:
Publications of Results:
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Responsible Party: Orhan SAHIN, M.D., MD,, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01555671     History of Changes
Other Study ID Numbers: 02-11-11-Rev-1
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Keywords provided by Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research Hospital:
labor,
meperidine,
active phase,
duration of labor
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Meperidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia