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Phase 4 N=250 Randomized Triple-blind Supportive Care

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

Labor Pain

Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: The Duration of Active Phase of Labour — 249; 304 minutes — p=0.029

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Meperidine (Drug); Saline (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Primary completion
May 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
The Duration of Active Phase of Labour
249; 304 0.029 sig
SECONDARY
Total Duration of Labour
273; 331
SECONDARY
Duration of the Second Stage of Labour
24; 27

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01555671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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