Determination of the auxiliary effect of melatonin in the prevention of preeclampsia in women with moderate and high risk
Design
The clinical trial has a control group with a parallel intervention group in a blinded three-way, simple randomized block, phase 2-3 on 120 patients, rand excel function is used for randomization.
Settings and conduct
Shahid Beheshti Hospital, Kashan
Participants/Inclusion and exclusion criteria
Inclusion criteria
16 years and older
12-28 weeks of pregnancy
moderate to high risk of preeclampsia based on US Preventive Services Task Force criteria
Having informed consent
Exclusion criteria
Multiple pregnancy
Current or previous use of melatonin in the past 6 weeks
Allergy to melatonin and aspirin
Use of any of the following drugs that can interfere with the metabolism and/or elimination of melatonin: fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors. Carbamazepine, rifampicin and other CYP1A2 inducers. and zalplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics.
lose to follow-up
non cooperate
The presence of any disease or condition that is a contraindication for continued pregnancy
Fetal anomaly
Intervention groups
Taking aspirin with melatonin
Main outcome variables
Occurrence of preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230930059563N1
Registration date:2023-12-30, 1402/10/09
Registration timing:registered_while_recruiting
Last update:2023-12-30, 1402/10/09
Update count:0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Mozhgan Alishahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5500 9999
Email address
alishahimozhgan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-26, 1402/09/05
Expected recruitment end date
2024-01-25, 1402/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating of the adjuvant effect of melatonin in the prevention of preeclampsia in moderate and high risk women
Public title
The effect of melatonin in the prevention of preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
16 years and older
12-28 weeks of pregnancy
moderate to high risk of preeclampsia based on US Preventive Services Task Force criteria
informed consent
Exclusion criteria:
Multiple pregnancy
Current or previous use of melatonin in the past 6 weeks
Allergy to melatonin and aspirin
Use of any of the following drugs that can interfere with the metabolism and/or elimination of melatonin: fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors. Carbamazepine, rifampicin and other CYP1A2 inducers. and zalplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics.
lose to follow-up
non cooperate
The presence of any disease or condition that is a contraindication for continued pregnancy
Fetal anomaly
Age
From 16 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be using random allocation in blocks of 6. Thus, in each block of 6, 3 patients will be in the intervention group and 3 patients will be in the control group. At the beginning of block selection, patients are selected by simple random method using random numbers until the chance of accepting the patient in the block is 100%, in which case patients are selected in that group to complete the block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Both groups will receive the drugs in the same packaging, size and box. The codes will remain with one of the colleagues of the research project and will be decoded at the end of the study. None of the presenters and patients know the type of codes of each patient until after the data analysis, thus this study is conducted in a triple blind manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Hekmat 55 Street, Qutb Rawandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2023-09-10, 1402/06/19
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.138
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14.9
ICD-10 code description
Unspecified pre-eclampsia
Primary outcomes
1
Description
Occurrence of preeclampsia
Timepoint
The time interval until the occurrence of pre-eclampsia or termination of pregnancy, whichever is earlier.
Method of measurement
Based on clinical examination
Secondary outcomes
1
Description
Type of delivery
Timepoint
Once upon a time
Method of measurement
clinical basis
2
Description
neonate Apgar
Timepoint
Once at the moment of the birth
Method of measurement
Based on the Apgar scoring system
3
Description
Newborn characteristics (height-weight)
Timepoint
Once at the moment of the birth
Method of measurement
Based on the standard method of measuring the height and weight of the baby
Intervention groups
1
Description
Intervention group: Aspirin + melatonin
Category
Prevention
2
Description
Control group: Aspirin
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شهید بهشتی کاشان
Full name of responsible person
مژگان علیشاهی
Street address
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5558 9444
Email
info@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
کاشان، بلوار قطب راوندی، کوچه حکمت ۵۵
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mozhgan Alishahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9338
Email
alishahimozhgan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
مرضیه طالبیان
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5558 9444
Email
talebianm861@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mozhgan Alishahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 935 550 2153
Email
alishahimozhgan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Age, body mass index, blood pressure, baby weight, number of pregnancies, nationality, education, gestational age at arrival, gestational age at delivery, treatment group, type of delivery, occurrence of pre-eclampsia, baby Apgar, baby height, baby head circumference
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use for the purpose of meta-analyses is allowed. In other matters, it is necessary to obtain permission from the owner of the license.
From where data/document is obtainable
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
Obstetrics and Gynecology Group
00983155589444
What processes are involved for a request to access data/document
Call or send a request to the Obstetrics and Gynecology Department of Kashan University of Medical Sciences