Magnesium for Neonatal Neuroprotection and Mothers (MnMs)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01482078|
Recruitment Status : Recruiting
First Posted : November 30, 2011
Last Update Posted : April 10, 2018
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 or disease|
|Premature Birth Sedation During Labor and Delivery; Complications, Pulmonary Respiratory Depression|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Prospective Observational Study, Maternal Effects of Magnesium Sulphate for Neonatal Neuroprotection in Women Having Cesarean Section Under Neuraxial Anesthesia|
|Actual Study Start Date :||January 26, 2012|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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:
- Maximal Expiratory Pressure [ Time Frame: 3 minutes for each of 5 tests over 2 hours ]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 ]
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 ]
- 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 ]
- lowest sedation score <4 (% of patients)
- sedation score decrease of >1 from baseline (% of patients) • nausea and vomiting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482078
|Contact: James D Taylor, BSc||604-875-2424 ext firstname.lastname@example.org|
|Contact: James Brown, MB BCh||604-875-2424 ext 6120||James.Brown@cw.bc.ca|
|Canada, British Columbia|
|BC Women's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Contact: James D Taylor, BSc 604-875-2424 ext 6076 email@example.com|
|Contact: James Brown, MB BCh 604-875-2424 ext 6120 James.Brown@cw.bc.ca|
|Principal Investigator: James PR Brown, MBChB|
|Sub-Investigator: Joanne Douglas, MD|
|Sub-Investigator: Susan Bright, MD|
|Sub-Investigator: Amanda Skoll, MD|
|Sub-Investigator: James Taylor, BSc|
|Sub-Investigator: Vit Gunka, MD|
|Principal Investigator: Anna West, MBBS|
|Principal Investigator:||James Brown, MB BCh||BC Women's Hospital, University of British Columbia|