Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tenoxicam
Intravenous administration of tenoxicam, a lyophilisate with 20 mg to be dissolved and diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
Tenoxicam
Pethidine
Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
Pethidine
Interventions
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Tenoxicam
Pethidine
Eligibility Criteria
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Inclusion Criteria
* Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
* Maternal age between 20-30 years
* Singleton term pregnancy (37-42 weeks of gestation)
* Vertex-presenting fetus
Exclusion Criteria
* Scarred uterus; previous cesarean section, hysterotomy or myomectomy
* Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
* Fetal distress
* Receiving any regional or parenteral analgesia before recruitment in the study
* Known hypersensitivity to the drug family
20 Years
30 Years
FEMALE
Yes
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Hamdy Bakry Mohye Soliman El Kinawy
TA
Other Identifiers
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IP-TXM
Identifier Type: -
Identifier Source: org_study_id
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