UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039038 |
|---|---|
| Receipt number | R000044512 |
| Scientific Title | Magnesium sulfate versus combination of magnesium and phentolamine for control of blood pressure in pregnancy induced hypertension |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2019/12/31 21:20:30 |
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Basic information
Public title
Magnesium sulfate versus combination of magnesium and phentolamine for control of blood pressure in pregnancy induced hypertension
Acronym
Magnesium sulfate versus combination of magnesium and phentolamine in pregnancy induced hypertension
Scientific Title
Magnesium sulfate versus combination of magnesium and phentolamine for control of blood pressure in pregnancy induced hypertension
Scientific Title:Acronym
Magnesium sulfate versus combination of magnesium and phentolamine in pregnancy induced hypertension
Region
| Africa |
Condition
Condition
blood pressure control in preclampsia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will examine the efficacy of combination of Phentolamine infusion with Magnesium sulfate in management of urgent preeclampsia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of the combination of magnesium sulfate and phentolamine in the treatment of patients with hypertensive disorder with pregnancy (HDCP)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control group C. will be given an intravenous infusion of 25 ml of magnesium sulfate and 100 ml of glucose solution with a concentration of 5% the infusion will be finished in 30 min. The patients will then be given an intravenous infusion of 60 ml of magnesium sulfate with a concentration of 25%. Finally, the patients will intravenously be instilled with 10 ml of magnesium sulfate
Interventions/Control_2
group P will receive the combination treatment of magnesium sulfate and phentolamine on the basis of single first loading dose of magnesium sulfate will be included in the phentolamine (20 mg of phentolamine will be added to the glucose solution with a concentration of 5%), and the patients will intravenously instilled with this mixed solution
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who will be included conformed to the diagnostic criteria of moderate and severe gestational hypertension.
Key exclusion criteria
intolerance or allergy to magnesium sulfate or phentolamine; mental illnesses and serious medical diseases as cerebral compromised or renal insufficiency
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Wafiya |
| Middle name | R. |
| Last name | Mahdy |
Organization
Faculty of medicine Menofia university
Division name
Anesthesia department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201094245826
wafia.mahdi@med.menofia.edu.eg
Public contact
Name of contact person
| 1st name | Ghada |
| Middle name | |
| Last name | Hassan |
Organization
Menofia University
Division name
Anesthesia department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201001592001
Homepage URL
ghada.ibrahim@med.menofia.edu.eg
Sponsor or person
Institute
Faculty of medicine Menofia university, Egypt
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine Menofia university, Egypt
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of medicine, Menofia University, Egypt
Address
Egyopt, Shebin El-Kom, Yassin Abdel Ghaffar street
Tel
00201094245826
wafia.mahdi@med.menofia.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Anesthesia Department, Faculty of medicine Menofia university, Egypt
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 31 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044512
