Magnesium for Neonatal Neuroprotection and Mothers (MnMs)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01482078
First received: November 28, 2011
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition
Premature Birth
Sedation During Labor and Delivery; Complications, Pulmonary
Respiratory Depression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study, Maternal Effects of Magnesium Sulphate for Neonatal Neuroprotection in Women Having Cesarean Section Under Neuraxial Anesthesia

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Maximal Expiratory Pressure [ Time Frame: 3 minutes for each of 5 tests over 2 hours ] [ Designated as safety issue: Yes ]
    We consider 15 cmH20 difference in MEP to be clinically significant.

  • Composite sedation score [ Time Frame: 30 seconds for each of 6 tests over 2 hours ] [ Designated as safety issue: Yes ]

    A composite score of ≤3 (at any data collection point). This implies one of the following criteria:

    • Subject responds only after name is spoken loudly or repeatedly
    • Speech is slurred or slow
    • Marked relaxation of facial expression
    • Both eyes are glazed with marked ptosis.

    We judge this degree and incidence of sedation to be clinically significant. It would certainly be sufficient to interfere with maternal interaction with the newborn, would likely affect maternal memory of the event, and would place the mother at risk of potential airway compromise and respiratory insufficiency.



Secondary Outcome Measures:
  • To compare the following respiratory measurements [ Time Frame: 3 minutes for each of 5 tests over 2 hours ] [ Designated as safety issue: Yes ]
    • oxygen saturation ≤95% (% of patients)
    • ETCO2 increase of ≥5mmHg from baseline (% of patients)
    • MEP ≤ 60cmH20 (% of patients)
    • MIP 30% decrease from baseline (% of patients)
    • Forced Vital Capacity (FVC) decrease ≥30% from baseline (% of patients)

  • To compare the following sedation measurements [ Time Frame: 30 seconds for each of 6 tests over 2 hours ] [ Designated as safety issue: Yes ]
    • lowest sedation score <4 (% of patients)
    • sedation score decrease of >1 from baseline (% of patients) • nausea and vomiting


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Obstetric patients planning to deliver at British Columbia's Women's Hospital

  • MgSO4 infusion cohort

    -Eligible parturients at less than 34 weeks gestational age with potential pre-term labor, pre-term rupture of membranes or intrauterine growth restriction.

  • Non-MgSO4 infusion cohort -We will approach a control group of subjects: i.e. parturients undergoing cesarean section (elective or emergency) with neuraxial anesthesia.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482078

Locations
Canada, British Columbia
British Columbia's Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Vit Gunka, MD BC Women's Hospital, University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01482078     History of Changes
Other Study ID Numbers: H11-02970
Study First Received: November 28, 2011
Last Updated: June 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Magnesium Sulphate
Neuroprotection
Neuraxial Anesthesia
Sedation
Respiratory function
Cesarean Section
Obstetrical Anesthesia

Additional relevant MeSH terms:
Depression
Depressive Disorder
Premature Birth
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Respiration Disorders
Respiratory Tract Diseases
Anesthetics
Magnesium Sulfate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 22, 2014