Magnesium for Neonatal Neuroprotection and Mothers (MnMs)
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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 |
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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 |
- 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.
- 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 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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
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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:
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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 |
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.
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| Contact: Vit Gunka, MD | 604-875-2158 | vgunka@cw.bc.ca |
| Canada, British Columbia | |
| British Columbia's Women's Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3N1 | |
| Contact: Vit Gunka, MD 604-875-2158 vgunka@cw.bc.ca | |
| Sub-Investigator: James PR Brown, MBChB (Hons) | |
| Sub-Investigator: Joanne Douglas, MD | |
| Sub-Investigator: Susan Bright, MD | |
| Sub-Investigator: Amanda Skoll, MD | |
| Sub-Investigator: Danielle Murray, BA | |
| 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: | August 20, 2012 |
| 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:
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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 May 19, 2013