UMIN-CTR Clinical Trial

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