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Tramadol for Labour Analgesia in Low Risk Primiparous Women

Information source: Saint Thomas Hospital, Panama
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain During Labour

Intervention: Tramadol (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Saint Thomas Hospital, Panama

Official(s) and/or principal investigator(s):
Osvaldo Reyes, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital
Riggie Castillo, MD, Principal Investigator, Affiliation: Saint Thomas Maternity Hospital

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.

Clinical Details

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

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

Primary outcome: Pain during labour

Secondary outcome:

Duration of labour

Neonatal outcomes

Side effects

Requirements of oxytocin

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Saint Thomas Maternity Hospital, Panama 1439 zona 9A, Panama
Additional Information

Starting date: October 2012
Last updated: July 7, 2013

Page last updated: August 23, 2015

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