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

NCT01555671 | Completed Phase 4 Results DMC

• 1 other identifier: 02-11-11-Rev-1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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 two (control and study) groups. Our hypothesis is that the use of meperidine during active labor has no effect on the duration of labor.

Conditions

Labor Pain

Keywords

labor,; meperidine,; active phase,; duration of labor

Outcome Measures

Primary Outcomes (1)

• The Duration of Active Phase of Labour

  The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor

  24h

Secondary Outcomes (2)

• Total Duration of Labour

  24h

• Duration of the Second Stage of Labour

  24h

Study Arms (2)

meperidine administration group

ACTIVE COMPARATOR

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

plasebo group

PLACEBO COMPARATOR

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: Saline

Interventions

Meperidine DRUG

0.5 ml meperidine injection intravenously injected in randomly selected patients

Also known as: Aldolan 100 mg/2 ml

meperidine administration group

Saline DRUG

0.5 ml saline solution injection intravenously injected in randomly selected patients

Also known as: 0.90% w/v of NaCl

plasebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• gestational age between 38 and 42 weeks
• live fetus
• cephalic presentation
• in active phase of labour

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Prof.Dr.Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21890889 RESULT

• 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. doi: 10.1016/0002-9378(67)90471-1. No abstract available.

  PMID: 6021289 RESULT

• 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. doi: 10.1016/j.ajog.2004.03.017.

  PMID: 15507943 RESULT

• 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. doi: 10.1016/j.ejogrb.2005.11.033. Epub 2006 Jan 6.

  PMID: 16406273 RESULT

Related Links

• meperidine,duration of labor,induction of labor

MeSH Terms

Conditions

Labor Pain

Interventions

Meperidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Orhan SAHIN
• Organization: Prof.Dr.Cemil Tascioglu City Hospital

drorhansahin@gmail.com

+90 532 240 00 12

Study Officials

• Orhan SAHIN, MD

  Ministery of Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both drug provider and patient do not know which drug or placebo was given
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,

Model Details: Randomized parallel double blind plasebo controlled study

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 15, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2015
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Locations

TU (1)