UnknownNot Applicable

Magnesium for Neonatal Neuroprotection and Mothers

Canada50 participantsStarted 2012-01-26

Plain-language summary

Magnesium is a treatment for mothers to protect brains of babies born early. This study investigates combined effects of magnesium and spinal or epidural anesthesia on mothers having cesareans. The investigators will use a scoring system to measure sedation and devices that subjects breath in and out of to measure breathing strength. The investigators hypothesize the combination of magnesium and anesthesia will reduce breathing strength and cause sedation. This is an observational study comparing those having magnesium and anesthesia with those just having anesthesia. Routine medical care will not be altered. Results will hopefully allow anesthesiologists to provide better patient care.

Who can participate

Age range

19 Years

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: * Delivering by cesarean section at less than 34 weeks gestational age (maximum 33 weeks and 6 days). * ≥19 yr * Singleton or multiple pregnancy o There is potentially greater intra-abdominal pressure associated with multiple pregnancies, which may affect anesthetic block height by increasing blood volume in epidural blood vessels. It may also increase the risk of basal atelectasis and will affect respiratory mechanics to a greater extent. We plan to undertake sub-group analysis to test this effect. * Primiparous or multiparous * English-speaking * Undergoing cesarean section with neuraxial anesthesia (intrathecal, epidural or combined spinal epidural \[CSE\]). * Parturients response may not be identical to the different neuraxial techniques, e.g. the degree of respiratory motor blockade exhibited or onset of opioid effect. Therefore we plan to undertake sub-group analysis to test this effect. Exclusion Criteria: * Illegal, non-prescription drug use within the last year * Psychiatric disorder treated with medication within the last year

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

Maximal Expiratory Pressure

Timeframe: 3 minutes for each of 5 tests over 2 hours

Composite sedation score

Timeframe: 30 seconds for each of 6 tests over 2 hours

Trial details

NCT IDNCT01482078

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-07

Contact for this trial

James D Taylor, BSc

604-875-2424 james.taylor1@phsa.ca

View on ClinicalTrials.gov More Premature Birth trials