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

This study is currently recruiting participants.
Verified December 2012 by Kanuni Sultan Suleyman Training and Research
Sponsor:
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

March 14, 2012
December 13, 2012
January 2012
November 2012   (final data collection date for primary outcome measure)
The duration of active phase of labour [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor
Same as current
Complete list of historical versions of study NCT01555671 on ClinicalTrials.gov Archive Site
  • mode of delivery [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • need of oxytocin augmentation [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • meconium-stained liquor [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • instrumental delivery rate [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women
Is There Any Effect of Meperidine on the Length of Duration of Labor? A Prospective Randomized Controlled Trial.

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.

  • 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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arrested Active Phase of Labor as Antepartum Condition
  • Drug: Placebo
    Bag B (placebo group), containing 10 mL of normal saline solution
  • Drug: Meperidine
    50 mg meperidine injection intramusculer
    Other Name: aldolan
  • 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.
    Intervention: Drug: Meperidine
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
January 2013
November 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact: Orhan SAHIN, MD +90 212 473 03 03 ext 1803 drorhansahin@gmail.com
Contact: Orhan SAHİN +905056151961
Turkey
 
NCT01555671
02-11-11-Rev-1
Yes
Orhan SAHIN, M.D., Kanuni Sultan Suleyman Training and Research
Kanuni Sultan Suleyman Training and Research
Not Provided
Study Director: Orhan SAHIN, MD Ministery of Health
Kanuni Sultan Suleyman Training and Research
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP