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出境医 / 临床实验 / Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level
Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level
Study Description
Brief Summary:
Magnesium sulphate is an inorganic salt with multiple therapeutic applications in medicine it has been widely utilized and studied on a diverse set of conditions such as asthma, cardiac arrhythmia and stroke. In pregnant women ,MgSo4 has been used in many cases such as for seizures prophylaxis in preeclampsia, tocolysis in preterm labour and for fetal neuroprotection in immenint preterm delivery.MgSo4 has been used as the standard drug for tocolysis in preterm labour and other drugs have been compared to it.
| Condition or disease | Intervention/treatment |
|---|---|
| Pre-Eclampsia | Drug: Magnesium Sulfate |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level in Pregnant Recipients of Magnesium Sulphate |
| Actual Study Start Date : | June 30, 2019 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | November 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Study group
pregnant women admitted to Women's Health Hospital , Assiut university during 2019-2020 will be counseled to participate in the study
|
Drug: Magnesium Sulfate
4 gram MgSo4 diluted in 150 cc saline infused IV within 30 minutes as loading dose then the patient will receive the maintenance dose of 1gram MgSo4 per hour for 6 hours.
|
Outcome Measures
Primary Outcome Measures :
- the percentage of women reaching the Mg therapeutic level. [ Time Frame: 24 hours ]the Mg therapeutic level of 4,8 mg/dl.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
women included will be classified according to BMI underwieght ( less than 18.85) , Normal weight (18.5-24.9)
, Overweight (25-29.9) and obese (30 or more)
Criteria
Inclusion criteria:
pregnant women 34 weeks or less admitted to Women's Health Hospital with a diagnosis of :
- sever preeclampsia. It is defined as 1- blood pressure 160/110 mmHg or more 2- proteinurea (+3 or more by dipstick) 3-HELLP syndrome
- threatened preterm labour that will receive Magnesium Sulphate either for tocolysis or neuroprotection.
Exclusion criteria:
- women with more than 34 weeks gestation and with any contraindication for Magnesium Sulphate intake like severe renal impairment or myasthenia gravis.
Contacts and Locations
Locations
| Egypt | |
| Ahmed Abbas | Recruiting |
| Assiut, Cairo, Egypt, 002 | |
| Contact: ahmed abbas 00201003385183 bmr90@hotmail.com | |
Sponsors and Collaborators
Assiut University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 24, 2019 | ||||
| First Posted Date | April 26, 2019 | ||||
| Last Update Posted Date | April 23, 2021 | ||||
| Actual Study Start Date | June 30, 2019 | ||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
the percentage of women reaching the Mg therapeutic level. [ Time Frame: 24 hours ] the Mg therapeutic level of 4,8 mg/dl.
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level | ||||
| Official Title | Impact of Body Mass Index on Serum Maternal and Fetal Magnesium Level in Pregnant Recipients of Magnesium Sulphate | ||||
| Brief Summary | Magnesium sulphate is an inorganic salt with multiple therapeutic applications in medicine it has been widely utilized and studied on a diverse set of conditions such as asthma, cardiac arrhythmia and stroke. In pregnant women ,MgSo4 has been used in many cases such as for seizures prophylaxis in preeclampsia, tocolysis in preterm labour and for fetal neuroprotection in immenint preterm delivery.MgSo4 has been used as the standard drug for tocolysis in preterm labour and other drugs have been compared to it. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population |
women included will be classified according to BMI underwieght ( less than 18.85) , Normal weight (18.5-24.9) , Overweight (25-29.9) and obese (30 or more) |
||||
| Condition | Pre-Eclampsia | ||||
| Intervention | Drug: Magnesium Sulfate
4 gram MgSo4 diluted in 150 cc saline infused IV within 30 minutes as loading dose then the patient will receive the maintenance dose of 1gram MgSo4 per hour for 6 hours.
|
||||
| Study Groups/Cohorts | Study group
pregnant women admitted to Women's Health Hospital , Assiut university during 2019-2020 will be counseled to participate in the study
Intervention: Drug: Magnesium Sulfate
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
400 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | November 2021 | ||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion criteria: pregnant women 34 weeks or less admitted to Women's Health Hospital with a diagnosis of :
Exclusion criteria: - women with more than 34 weeks gestation and with any contraindication for Magnesium Sulphate intake like severe renal impairment or myasthenia gravis. |
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | |||||
| Listed Location Countries | Egypt | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03928691 | ||||
| Other Study ID Numbers | MAGPET | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ahmed Mohamed Abbas, Assiut University | ||||
| Study Sponsor | Assiut University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Assiut University | ||||
| Verification Date | April 2021 | ||||
