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

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Meperidine
Saline
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring labor,, meperidine,, active phase,, duration of labor

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • gestational age between 38 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

Sites / Locations

  • Prof.Dr.Cemil Tascioglu City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

meperidine administration group

plasebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total Duration of Labour
Total time of delivery of patients who gave birth including the second stage of delivery
Duration of the Second Stage of Labour
The period of time until the birth of the baby, since the patient being followed for delivery

Full Information

First Posted
March 14, 2012
Last Updated
September 2, 2021
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01555671
Brief Title
Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women
Official Title
Is There Any Effect of Meperidine on the Length of Duration of Labor? A Prospective Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
May 1, 2012 (Actual)
Study Completion Date
July 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Our aim is to examine the effect of the opioid derivative meperidine used during labor on the duration of labor in singleton pregnancies. The sample size was calculated using the Number Cruncher Statistical System (NCSS) / PASS 2007. Power 80% and significance level (α) 0.05, the mean (mean) ± standard deviation (SD) of the first 20 individuals included in the control group of the study (296.04 ± 170.02) and has minimal clinical significance for the active phase of labor from previous studies. We found that the sample size should be 200 (100/100) considering the duration (30 minutes). A Simple randomisation using a random-number table was performed by the independent nurse staff, who took no further part in the study.Using the sealed envelope technique, parturients were randomly allocated to two groups: A meperidine group and B normal saline group Age, height, weight, body mass index (BMI), gravida, parity, week of gestation, expected fetal weight (EFW), hemoglobin (Hb) and hematocrit (Hct) values and episiotomy requirements were recorded in two groups.Gender, birth weight, 1st and 5th minute Apgar scores and presence of meconium aspiration of the newborns in two groups were recorded. During labor, oxytocin induction was not performed during the latent phase in accordance with the routine protocol of our hospital. Pregnant women in both groups were given oxytocin (Synpitan® amp) at a concentration of 1% by 10 drops/min by performing amniotomy when Bishop score was 6 or cervix dilation was 4 cm and when 70% effacement was achieved. In the meperidine group, when the cervical opening was 6 cm and 70% washout, 25 mg iv bolus injection of meperidine (2.5 ml) was administered. The same amount (2.5 ml) of physiological saline was administered intravenously to the subjects in the control group. The patients were followed in NST until 10 cm clearance and 100% effacement. This time was recorded as active phase time. The time from the end of the active phase period to the birth of the baby was recorded as the duration of the second phase of birth. The primary outcome of interest in this study is the duration of active phase of labor .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor,, meperidine,, active phase,, duration of labor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel double blind plasebo controlled study
Masking
ParticipantCare ProviderInvestigator
Masking Description
Both drug provider and patient do not know which drug or placebo was given
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
meperidine administration group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
plasebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Meperidine
Other Intervention Name(s)
Aldolan 100 mg/2 ml
Intervention Description
0.5 ml meperidine injection intravenously injected in randomly selected patients
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
0.90% w/v of NaCl
Intervention Description
0.5 ml saline solution injection intravenously injected in randomly selected patients
Primary Outcome Measure Information:
Title
The Duration of Active Phase of Labour
Description
The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor
Time Frame
24h
Secondary Outcome Measure Information:
Title
Total Duration of Labour
Description
Total time of delivery of patients who gave birth including the second stage of delivery
Time Frame
24h
Title
Duration of the Second Stage of Labour
Description
The period of time until the birth of the baby, since the patient being followed for delivery
Time Frame
24h

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: gestational age between 38 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orhan SAHIN, MD
Organizational Affiliation
Ministery of Health
Official's Role
Study Director
Facility Information:
Facility Name
Prof.Dr.Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21890889
Citation
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.
Results Reference
result
PubMed Identifier
6021289
Citation
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.
Results Reference
result
PubMed Identifier
15507943
Citation
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.
Results Reference
result
PubMed Identifier
16406273
Citation
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.
Results Reference
result
Links:
URL
http://www.nlm.nih.gov/medlineplus/
Description
meperidine,duration of labor,induction of labor

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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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