Study of the Effectiveness of Administration of Meperidine on the Length of Active Phase of Labor in Women
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

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 .
    

Intervention name(s): Meperidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 ml meperidine injection intravenously injected in randomly selected patients; 0.5 ml saline solution injection intravenously injected in randomly selected patients
Other intervention name(s): Aldolan 100 mg/2 ml; 0.90% w/v of NaCl
Intervention MeSH terms: Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized parallel double blind plasebo controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: labor,; meperidine,; active phase,; duration of labor