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.

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Meperidine; Drug: Saline

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 .

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Prof.Dr.Cemil Tascioglu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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; 0.5 ml meperidine injection intravenously injected in randomly selected patients; Other Names: Aldolan 100 mg/2 ml
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: Saline; 0.5 ml saline solution injection intravenously injected in randomly selected patients; Other Names: 0.90% w/v of NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Duration of Labour	Total time of delivery of patients who gave birth including the second stage of delivery	24h
Duration of the Second Stage of Labour	The period of time until the birth of the baby, since the patient being followed for delivery	24h

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Study Director: Orhan SAHIN, MD, Ministery of Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• meperidine,duration of labor,induction of labor

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: labor,; meperidine,; active phase,; duration of labor
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Meperidine
• Other Study ID Numbers: 02-11-11-Rev-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No