Recruiting

Magnesium

Sponsor:

University of British Columbia

Code:

NCT01482078

Conditions

Premature Birth

Sedation During Labor and Delivery; Complications, Pulmonary

Respiratory Depression

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Premature Birth

Sedation During Labor and Delivery; Complications, Pulmonary

Respiratory Depression

Study ID

NCT01482078

Start date

Jan 26, 2012

Status verified date

Oct, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Receive MgSO4 infusion

Parturients who present to the hospital at less than 34 weeks gestational age with potential pre-term labor, pre-term rupture of membranes or intrauterine growth restriction

Do not receive MgSO4 infusion

We will approach a control group of subjects: i.e. parturients undergoing cesarean section (elective or emergency) with neuraxial anesthesia.

We will seek to ensure that the control group is similar to the study group with respect to the following parameters:

  • Number of singleton or multiple pregnancy
  • Parity of parturients
  • Anesthetic technique (spinal or epidural)
  • Time of cesarean section (08:00-19:59 or 20:00 to 07:59) Once informed consent is obtained these subjects will be treated identically to the study group in terms of anesthetic management and data collection.

Primary outcome measure

  • Maximal Expiratory Pressure [ Time Frame: 3 minutes for each of 5 tests over 2 hours ]
  • Composite sedation score [ Time Frame: 30 seconds for each of 6 tests over 2 hours ]

Central Contacts and Locations

Central contacts

James D Taylor, BSc

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

James Brown, MB BCh

604-875-2424James.Brown@cw.bc.ca

Locations

BC Women's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

James D Taylor, BSc

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

James Brown, MB BCh

604-875-2424James.Brown@cw.bc.ca

Principal Investigator:

James PR Brown, MBChB

More Information

Sponsor

University of British Columbia

Last update posted

Oct 12, 2018

Last verified

Oct, 2018

Keywords

  • Magnesium Sulphate
  • Neuroprotection
  • Neuraxial Anesthesia
  • Sedation
  • Respiratory function
  • Cesarean Section
  • Obstetrical Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2018-10-12.