The evaluation of effect the melatonin with Sildenafil on intrauterine fetal growth restriction
Design
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 88 patients
Settings and conduct
Eligible patients with intrauterine growth restriction and uterine vascular Doppler disorder; umbilical artery midbrain, referring to a gynecology clinic of Yasuj University of Medical Science, divided into four groups of 22 individuals and pregnancy outcomes will be measured.
Participants/Inclusion and exclusion criteria
Single-pregnancy pregnancy with IUGR
Pregnancy's age between 26 and 32 weeks
Mother's age between 18 to 45 years
No using alcohol and cigarettes
Normal anomaly scan
The absence of fetal with known or suspected anomalies
No gestational or chronic diagnosed diabetes
Not using other vasodilator drugs such as nitric oxide and calcium channel blockers
Intervention groups
Group A (sildenafil): In this group, sildenafil citrate tablets (Vizarcin), 25 mg orally every eight hours for four weeks.
Group B (Melatonin): In this group, melatonin tablets (Razak Pharmaceutical Company, Iran) are prescribed three mg three times a day (morning, lunch, before bed) for four weeks.
Group C (sildenafil with melatonin): In this group, the drug dose will be the same as the drug group A and B.
Group D: Plasbo drug containing starch is prescribed in the same way as the above intervention groups.
Main outcome variables
Weight percentile
Abdominal circumference growth
Fetal amniotic fluid index
Pregnancy duration
Neonate anthropometric measurements (height and weight)
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N6
Registration date:2020-06-30, 1399/04/10
Registration timing:registered_while_recruiting
Last update:2020-06-30, 1399/04/10
Update count:0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-20, 1398/07/28
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Sildenafil Citrate with melatonin on intrauterine growth restriction
Public title
Sildenafil Citrate with melatonin and intrauterine growth restriction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single-pregnancy pregnancy with IUGR
Pregnancy's age between 26 and 32 weeks
Mother's age between 18 to 45 years
No using alcohol and cigarettes
Normal anomaly scan
The absence of fetal with known or suspected anomalies
No gestational or chronic diagnosed diabetes
Not using other vasodilator drugs such as nitric oxide and calcium channel blockers
Exclusion criteria:
Lack of follow-up
Unwillingness to participate in the study
Complications such as premature rupture of membrane, vaginal bleeding, and intrauterine infection
Sildenafil sensitivity and tolerance to side effects (flushing, visual disturbances, severe drop in blood pressure and hearing impairment)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use envelopes in the package
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding method is patients and physicians will not be aware of their allocation to study groups and all medications will be placed into same capsules of size, shape and color by the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
یاسوج
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.YUMS.REC.1398.129
Health conditions studied
1
Description of health condition studied
Intrauterine growth restriction
ICD-10 code
P05
ICD-10 code description
Disorders of newborn related to slow fetal growth and fetal malnutrition
Primary outcomes
1
Description
Weight percentile
Timepoint
At each visit pregnancy
Method of measurement
Ultrasound
2
Description
Abdominal circumference growth
Timepoint
At each visit pregnancy
Method of measurement
Ultrasound
3
Description
Fetal amniotic fluid index
Timepoint
At each visit pregnancy
Method of measurement
Ultrasound
4
Description
Pregnancy duration
Timepoint
End of pregnancy
Method of measurement
Questionnaire
5
Description
Neonate anthropometric measurements (height and weight)
Timepoint
Delivery time
Method of measurement
Scales and meters
6
Description
Quality of life
Timepoint
End of intervention
Method of measurement
Questionnaire
7
Description
Sleep quality
Timepoint
End of intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group A (sildenafil): In this group, sildenafil citrate tablets (Vizarcin), 25 mg orally every eight hours for four weeks.
Category
Treatment - Drugs
2
Description
Group B (Melatonin): In this group, melatonin tablets (Razak Pharmaceutical Company, Iran) are prescribed three mg three times a day (morning, lunch, before bed) for four weeks.
Category
Treatment - Drugs
3
Description
Group C (sildenafil with melatonin): In this group, the drug dose will be the same as the drug group A and B.
Category
Treatment - Drugs
4
Description
Group D: Plasbo drug containing starch is prescribed in the same way as the above intervention groups.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Shakiba Amirjani
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
Shakiba.amirjani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari-Oriad
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
Shakiba.amirjani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Shakiba Amirjani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
Shakiba.amirjani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shakiba Amirjani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
Shakiba.amirjani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shakiba Amirjani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
یاسوج
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
Shakiba.amirjani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD