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

Information source: Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arrested Active Phase of Labor as Antepartum Condition

Intervention: Placebo (Drug); Meperidine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Kanuni Sultan Suleyman Training and Research Hospital

Official(s) and/or principal investigator(s):
Orhan SAHIN, MD, Study Director, Affiliation: Ministery of Health

Overall contact:
Orhan SAHIN, MD, Phone: +90 212 473 03 03, Ext: 1803, Email: drorhansahin@gmail.com

Summary

Labor pain is universal and occurs acutely. This is the most painful experience in a woman's life. Pain relief during labor is expected to have positive impact on the progress, outcome and cost of labor. However, it is controversial whether labor analgesia shortens the length of labor and influences progression to cesarean. Labor analgesia can be performed via spinal, epidural or systemic routes (intravenous or intramuscular). Opioid agonists (meperidine, fentanyl etc.) as well are the systemic agents frequently used for labor analgesia. Results of the studies concerning effect of meperidine on the length of labor are controversial. Many studies have expressed that meperidine has no effect or effect on the progress of labor. 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 case and control groups.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The duration of active phase of labour

Secondary outcome:

mode of delivery

duration of the second stage of labour

need of oxytocin augmentation

meconium-stained liquor

instrumental delivery rate

maternal satisfaction score for the birth process obtained within 24 h of delivery [a visual analog scale (VAS) of 0-10, with higher score denoting greater satisfaction]

Detailed description:

- Participant eligibility for the study included gestational age between 34 and 42 weeks,

live fetus, cephalic presentation, and were in active phase of labour with well-establish uterine contractions (3 contractions within 10 min) and cervical dilatation between 3 and 5 cm with a partially effaced cervix ( %70 or more ).

- Exclusion criteria are placenta previa, placental abruption, caesarean section or any

uterine scarring, abnormal placentation (accreta, increta, or percreta), multiple gestation, fetal macrosomia (≥4000 g), suspicious of cephalopelvic disproportion, meperidine allergy, use any kind of labour induction or augmentation before on admission for delivery in our hospital.

- A Simple randomisation using a random-number table was performed by the investigational

pharmacy staff, who took no further part in the study.

- The primary outcome of interest in this study is the labor duration.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- gestational age between 34 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

Locations and Contacts

Orhan SAHIN, MD, Phone: +90 212 473 03 03, Ext: 1803, Email: drorhansahin@gmail.com

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul 34306, Turkey; Recruiting
Orhan SAHIN, MD, Phone: +90 212 473 03 03
Orhan SAHIN, MD, Principal Investigator
Additional Information

meperidine,duration of labor,induction of labor

Starting date: January 2012
Last updated: December 13, 2012

Page last updated: August 23, 2015

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