Tramadol for Labour Analgesia in Low Risk Primiparous Women
Information source: Saint Thomas Hospital, Panama
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain During Labour
Intervention: Tramadol (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Saint Thomas Hospital, Panama Official(s) and/or principal investigator(s): Osvaldo Reyes, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital Riggie Castillo, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital
Summary
Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately
severe pain. It has been previously evaluated as a method to reduce pain during labour, but
there is always some fear related to its effects (neonatal respiratory depression). The
purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to
pain during labour, duration of labour and neonatal outcomes.
Clinical Details
Official title: Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain during labour
Secondary outcome: Duration of labourNeonatal outcomes Side effects Requirements of oxytocin
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Gestational age between 37 and 40 6/7 weeks
- Primiparous patient
- Singleton
- 4 to 5 cms of dilation
- Intact membranes or spontaneous rupture of membranes less than 2 hours
- Fetus in a vertex presentation
- Gynecoid pelvis by clinical examination
Exclusion Criteria:
- Multiparous
- Multiple pregnancies
- Any pathology
- Induction of labour with prostaglandins
Locations and Contacts
Saint Thomas Maternity Hospital, Panama 1439 zona 9A, Panama
Additional Information
Starting date: October 2012
Last updated: July 7, 2013
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