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Completed

NCT Number: NCT01555671

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Prof.Dr.Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

  • 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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meperidine

Drug

0.5 ml meperidine injection intravenously injected in randomly selected patients

Other names: Aldolan 100 mg/2 ml

Saline

Drug

0.5 ml saline solution injection intravenously injected in randomly selected patients

Other names: 0.90% w/v of NaCl

Primary outcomes

  1. The Duration of Active Phase of Labour

    Time frame: 24h

    The primary outcome is to evaluate whether meperidine is effective in shortening the duration of the active phase of labor

Secondary outcomes

  1. Total Duration of Labour

    Time frame: 24h

    Total time of delivery of patients who gave birth including the second stage of delivery

  2. Duration of the Second Stage of Labour

    Time frame: 24h

    The period of time until the birth of the baby, since the patient being followed for delivery

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

Is There Any Effect of Meperidine on the Length of Duration of Labor? A Prospective Randomized Controlled Trial.

Important dates

Study start
2012
Primary completion
2012
Study completion
2015
First posted
Mar 15, 2012
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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