Tramadol for Labour Analgesia in Low Risk Primiparous Women
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|ClinicalTrials.gov Identifier: NCT01889979|
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : July 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pain During Labour||Drug: Tramadol Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2013|
100 mg of tramadol SC (single dose) = 2 mL
100 mg of Tramadol was applied in the forearm SC (single dose).
Placebo Comparator: Placebo
2 mL of a sterile solution SC
2 ml of a sterile solution was applied in the forearm SC (single dose).
- Pain during labour [ Time Frame: 6 hours ]Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).
- Duration of labour [ Time Frame: 12 hours ]The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.
- Neonatal outcomes [ Time Frame: 48 hours ]Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.
- Side effects [ Time Frame: 48 hours ]Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.
- Requirements of oxytocin [ Time Frame: 12 hours ]Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889979
|Saint Thomas Maternity Hospital|
|Panama, Panama, 1439 zona 9A|
|Principal Investigator:||Osvaldo Reyes, MD||Saint Thomas Maternity Hospital|
|Principal Investigator:||Riggie Castillo, MD||Saint Thomas Maternity Hospital|