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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039038
Receipt No. 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

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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
Obsterics 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
Email 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
Email ghada.ibrahim@med.menofia.edu.eg

Sponsor
Institute Faculty of medicine Menofia university, Egypt
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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