Tramadol for Labour Analgesia in Low Risk Primiparous Women

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01889979

Enrollment

100

Registered

2013-07-01

Start date

2012-10-31

Completion date

2013-06-30

Last updated

2013-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain During Labour

Keywords

Pain during labour, Duration of labour, Apgar score, Umbilical cord pH

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.

Interventions

DRUGTramadol

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026