Working… Menu

Tramadol for Labour Analgesia in Low Risk Primiparous Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01889979
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : July 9, 2013
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief 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.

Condition or disease Intervention/treatment Phase
Pain During Labour Drug: Tramadol Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: Tramadol
100 mg of tramadol SC (single dose) = 2 mL
Drug: Tramadol
100 mg of Tramadol was applied in the forearm SC (single dose).

Placebo Comparator: Placebo
2 mL of a sterile solution SC
Drug: Placebo
2 ml of a sterile solution was applied in the forearm SC (single dose).

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. Neonatal outcomes [ Time Frame: 48 hours ]
    Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.

  3. Side effects [ Time Frame: 48 hours ]
    Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.

  4. Requirements of oxytocin [ Time Frame: 12 hours ]
    Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01889979

Layout table for location information
Saint Thomas Maternity Hospital
Panama, Panama, 1439 zona 9A
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Layout table for investigator information
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Maternity Hospital
Principal Investigator: Riggie Castillo, MD Saint Thomas Maternity Hospital
Layout table for additonal information
Responsible Party: Osvaldo A. Reyes T., Coordinator of Research, Saint Thomas Hospital, Panama Identifier: NCT01889979    
Other Study ID Numbers: MHST2012-09
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Pain during labour
Duration of labour
Apgar score
Umbilical cord pH
Additional relevant MeSH terms:
Layout table for MeSH terms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents