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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 because the information has not been verified recently.
Verified December 2012 by Kanuni Sultan Suleyman Training and Research Hospital.
Recruitment status was  Recruiting
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Kanuni Sultan Suleyman Training and Research Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
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)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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:
meperidine,duration of labor,induction of labor  This link exits the ClinicalTrials.gov site

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
Health Authority: Turkey: Ministry of Health

Keywords provided by Kanuni Sultan Suleyman Training and Research Hospital:
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 September 29, 2016