Magnesium for Neonatal Neuroprotection and Mothers (MnMs)
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.
Sedation During Labor and Delivery; Complications, Pulmonary
|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
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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:
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482078
|Contact: Vit Gunka, MDfirstname.lastname@example.org|
|Canada, British Columbia|
|British Columbia's Women's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Contact: Vit Gunka, MD 604-875-2158 email@example.com|
|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|