NCT01555671

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Labor Pain

Interventions

Type	Name	Description
DRUG	Meperidine	0.5 ml meperidine injection intravenously injected in randomly selected patients
DRUG	Saline	0.5 ml saline solution injection intravenously injected in randomly selected patients

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2015-07-01
• First posted: 2012-03-15
• Last updated: 2021-09-30
• Results posted: 2021-09-30

Locations

1 site across 1 country: Turkey (Türkiye)