Tramadol for Labour Analgesia in Low Risk Primiparous Women

S

Saint Thomas Hospital (HST)

Status and phase

Completed
Phase 3

Conditions

Pain During Labour

Treatments

Drug: Placebo
Drug: Tramadol

Study type

Interventional

Funder types

Other

Identifiers

NCT01889979
MHST2012-09

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Tramadol
Experimental group
Description:
100 mg of tramadol SC (single dose) = 2 mL
Treatment:
Drug: Tramadol
Placebo
Placebo Comparator group
Description:
2 mL of a sterile solution SC
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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