Tramadol for Labour Analgesia in Low Risk Primiparous Women

Phase 3

Completed

• Conditions: Pain During Labour
• Interventions: Drug: Placebo; Drug: Tramadol

• Registration Number: NCT01889979
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-28
• Status Verified: 2013-07
• Study First Posted: 2013-07-01
• Last Update Submitted: 2013-07-07
• Last Update Posted: 2013-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 mL of a sterile solution SC
Tramadol	Tramadol	100 mg of tramadol SC (single dose) = 2 mL

Primary Outcome Measures

Name	Time	Method
Pain during labour	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

Name	Time	Method
Duration of labour	12 hours	The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.
Neonatal outcomes	48 hours	Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.
Side effects	48 hours	Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.
Requirements of oxytocin	12 hours	Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama