Labor Pain
Conditions
Keywords
labor,, meperidine,, active phase,, duration of labor
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 .
Interventions
DRUGMeperidine
0.5 ml meperidine injection intravenously injected in randomly selected patients
DRUGSaline
0.5 ml saline solution injection intravenously injected in randomly selected patients
Sponsors
Kanuni Sultan Suleyman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Both drug provider and patient do not know which drug or placebo was given
Intervention model description
Randomized parallel double blind plasebo controlled study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Duration of Active Phase of Labour | 24h | The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Duration of Labour | 24h | Total time of delivery of patients who gave birth including the second stage of delivery |
| Duration of the Second Stage of Labour | 24h | The period of time until the birth of the baby, since the patient being followed for delivery |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
The study was planned to be carried out between January 2012 and May 2012 in Kanuni Sultan Süleyman training and research hospital(Istanbul-Turkey), gynecology and obstetrics department.
Pre-assignment details
A total of 449 patients were included in the study. 199 patients who did not meet the inclusion criteria were excluded from the study. The remaining 250 patients were randomized to the groups.
Participants by arm
| Arm | Count |
|---|---|
| Study Group 0.5 ml meperidine injection intravenously injected in randomly selected patients | 125 |
| Plasebo Group 0.5 ml saline solution injection intravenously injected in randomly selected patients | 125 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 20 | 25 |
Baseline characteristics
| Characteristic | Plasebo Group | Study Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 125 Participants | 250 Participants |
| Age, Continuous | 26.03 years STANDARD_DEVIATION 4.8 | 25.21 years STANDARD_DEVIATION 5.17 | 25.83 years STANDARD_DEVIATION 5.06 |
| Region of Enrollment Turkey | 125 participants | 125 participants | 250 participants |
| Sex: Female, Male Female | 125 Participants | 125 Participants | 250 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 105 | 4 / 100 |
| serious Total, serious adverse events | 0 / 105 | 0 / 100 |
Outcome results
Primary
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
Time frame: 24h
Population: women giving birth at term period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meperidine Administration Group | The Duration of Active Phase of Labour | 249 minutes | Standard Deviation 122 |
| Plasebo Group | The Duration of Active Phase of Labour | 304 minutes | Standard Deviation 167 |
p-value: 0.029Wilcoxon (Mann-Whitney)
Secondary
Duration of the Second Stage of Labour
The period of time until the birth of the baby, since the patient being followed for delivery
Time frame: 24h
Population: duration of the second stage of labour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meperidine Administration Group | Duration of the Second Stage of Labour | 24 minutes | Standard Deviation 15 |
| Plasebo Group | Duration of the Second Stage of Labour | 27 minutes | Standard Deviation 22 |
Secondary
Total Duration of Labour
Total time of delivery of patients who gave birth including the second stage of delivery
Time frame: 24h
Population: Total time of delivery of patients who gave birth including the second stage of delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meperidine Administration Group | Total Duration of Labour | 273 minutes | Standard Deviation 129 |
| Plasebo Group | Total Duration of Labour | 331 minutes | Standard Deviation 177 |