CompletedPhase 3

Tramadol for Labour Analgesia in Low Risk Primiparous Women

Panama100 participantsStarted 2012-10

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain during labour

Timeframe: 6 hours

Trial details

NCT IDNCT01889979

SponsorSaint Thomas Hospital, Panama

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Pain During Labour trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.