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Completed

NCT Number: NCT01889979

Tramadol for Labour Analgesia in Low Risk Primiparous Women

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.

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Key information

Conditions

Pain During Labour

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Saint Thomas Maternity Hospital

Panama City, 1439 zona 9A, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

100 mg of Tramadol was applied in the forearm SC (single dose).

Placebo

Drug

2 ml of a sterile solution was applied in the forearm SC (single dose).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2013
Registry last updated
Jul 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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