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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Locations

Turkey

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey, 34306

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 

Publications of Results:

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. Review.

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.

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.

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. Epub 2006 Jan 6.

• 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
• 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:

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