Tramadol for Labour Analgesia in Low Risk Primiparous Women

Pain During Labour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889979
• Other study ID #: MHST2012-09
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2013
• Last updated: July 7, 2013
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain During Labour

Intervention

Drug:
• Tramadol
100 mg of Tramadol was applied in the forearm SC (single dose).
• Placebo
2 ml of a sterile solution was applied in the forearm SC (single dose).

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during labour	Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).	6 hours	No
Secondary	Duration of labour	The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.	12 hours	No
Secondary	Neonatal outcomes	Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.	48 hours	Yes
Secondary	Side effects	Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.	48 hours	Yes
Secondary	Requirements of oxytocin	Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.	12 hours	No