Study of the therapeutic effect of Sildenafil Citrate on maternal and fetal outcomes of complicated pregnant women with severe preeclampsia
Design
A total of 64 single-pregnant women with severe preeclampsia indicating an expectant management and aging between 24 and 34 weeks were randomly and triple blind assigned to two groups of 1 and 2 treated with placebo and drug.
Settings and conduct
Patients with severe preeclampsia admitted to the maternity ward of Qaem Hospital in Mashhad who are eligible to enter the study are included. Individuals are randomly treated with medication and placebo through closed packets. So the therapist and patients and statistician do not know the type of drug they receive.
Participants/Inclusion and exclusion criteria
Pregnant women aged 18-50 years old with single pregnancy with a gestational age of 24 to 34 weeks who have been diagnosed with severe preeclampsia and who are candidate for expectant management, enrolled in the study.
Exclusion criteria: History of chronic hypertension, chronic diseases such as diabetes; fetal malformations or maternal comorbiditis leading to early pregnancy termination; use of drugs such as erythromycin; israconazole; ketoconazole; antiretroviral compounds or any other drug It interferes with sildenafil; and drugs used to reduce blood pressure eccept methyl dopa.
Intervention groups
Sildenafil is given as an intervention to individuals and to Placebo with the same form and color is given to the other group.
Main outcome variables
Primary outcome: The mean pregnancy time from preeclampsia diagnosis to termination of pregnancy
Secondary outcomes: mean maternal blood pressure; the need for prescribing oral and intravenous antihypertensive drugs; examining the number of sildenafil doses consumed from prescription to termination of pregnancy; maternal complications and fetal complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190201042577N1
Registration date:2019-03-07, 1397/12/16
Registration timing:registered_while_recruiting
Last update:2019-03-07, 1397/12/16
Update count:0
Registration date
2019-03-07, 1397/12/16
Registrant information
Name
Azadeh Kamkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3611 1357
Email address
kamkara951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-19, 1397/10/29
Expected recruitment end date
2020-01-19, 1398/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The therapeutic effect of Sildenafil Citrate on maternal and fetal outcomes of pregnancies associated with severe preeclampsia
Public title
The therapeutic effect of Sildenafil Citrate on maternal and fetal outcomes of pregnancies associated with severe preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with single pregnancy with gestational age 24 to 34 weeks
Ladies 18 to 50 years old
Patients with the diagnosis of severe preeclampsia (systolic blood pressure greater than 160 and diastolic blood pressure greater than 110 in two times with a minimum measurement time of 4 hours and proteinuria greater than 300 mg in 24 hours) indicating an expected treatment.
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual unit; using a packet packet
Blinding (investigator's opinion)
Triple blinded
Blinding description
Individuals entered into the study are randomly and triple blind divided into two groups by closed packets. The original drug and placebo were named by someone other than the therapist and researcher with the same shape and color as the first drug and the second drug, and each drug was given two groups. Data are analyzed by a statistician who is not aware of the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Ferdowsi University, Faculty of Medicine
City
mashhad
Province
Razavi Khorasan
Postal code
9177948964
Approval date
2019-01-11, 1397/10/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.582
Health conditions studied
1
Description of health condition studied
Severe Preeclampsia
ICD-10 code
O14.1
ICD-10 code description
Severe pre-eclampsia
Primary outcomes
1
Description
The mean of the pregnancy period since the diagnosis of severe preeclampsia until the end of pregnancy
Timepoint
since the diagnosis of severe preeclampsia until the end of pregnancy
Method of measurement
day
Secondary outcomes
1
Description
mean maternal blood pressure
Timepoint
Every four hours
Method of measurement
mercury Barometer
2
Description
newborn birth weight
Timepoint
at birth
Method of measurement
scaler
Intervention groups
1
Description
Intervention group: receive sildenafil tablets 25 mg every 8 hours.
Category
Treatment - Drugs
2
Description
Control group: receive a tablet of the same color and shape as the sildenafil tablet every 8 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Azadeh Kamkar
Street address
Ahmadabad Street, not reaching Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3854 3031
Email
Kamkara951@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqqodi
Street address
University of Mashhad University of Medical Sciences, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azadeh Kamkar
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 406, Sayed Razi 48 Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188737813
Phone
+98 51 3611 1357
Email
Kamkara951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azadeh Kamkar
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 406, Sayed Razi 48 Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188737813
Phone
+98 51 3611 1357
Email
kamkara951@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azadeh Kamkar
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 406, Sayed Razi 48 Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188737813
Phone
+98 51 3611 1357
Email
Kamkara951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available