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Evaluation of the effect of vaginal progesterone administration on ultrasonographic indicators and fetal and pregnancy outcomes of women at high risk of preeclampsia

Protocol summary

Study aim
Evaluation of the effect of vaginal progesterone administration on ultrasonographic indicators and fetal and pregnancy outcomes of women at high risk of preeclampsia
Design
Clinical trial with parallel control group, double blind, randomized, single center trial, Sample size 40 people.
Settings and conduct
Amiralmomenin Hospital In this study, the vascular resistance index and uterine artery pulsatility index, which are related to the use of aspirin and progesterone, are examined immediately before and 6 weeks after the start of the intervention. The patient and the specialist doctor evaluating the patients and the radiologist will remain unaware of the type of patient grouping and the drug used by each group.
Participants/Inclusion and exclusion criteria
The statistical population includes pregnant women referring to the women's clinics of Amirul Mominin Semnan. Inclusion criteria: Age 18 and above; Body mass index above 30; The interval between pregnancies is more than 10 years; Multiple pregnancy; Pre-gestational diabetes, Live singleton fetus. Exclusion criteria: Heart, liver, thyroid diseases, history of asthma; Aspirin sensitivity; Threatened abortion such as vaginal bleeding; Eclampsia and pre-eclampsia at the time of study.
Intervention groups
Intervention group: In this group; Treatment with oral aspirin tablets (Cardiosprin 80 grams, manufactured by Samisaz, Iran) on a daily basis from the 12th week of pregnancy to the 36th week; Together with vaginal progesterone suppositories (Cyclogest 400 mg, manufactured by Octoverco, Iran) daily from the 12th week of pregnancy to the 34th week. Control group: In this group; Treatment with oral aspirin tablets (Cardiopirin 80 grams, manufactured by Samisaz Company, Iran) is performed daily from the 12th week of pregnancy to the 36th week.
Main outcome variables
Vascular Resistance Index (RI), Pulsatile index (PI).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151228025732N72
Registration date: 2022-09-05, 1401/06/14
Registration timing: prospective

Last update: 2022-09-05, 1401/06/14
Update count: 0
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vaginal progesterone administration on ultrasonographic indicators and fetal and pregnancy outcomes of women at high risk of preeclampsia
Public title
Evaluation of the effect of vaginal progesterone administration on ultrasonographic indicators and fetal and pregnancy outcomes of women at high risk of preeclampsia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above Body mass index above 30 The interval between pregnancies is more than 10 years Multiple pregnancy Pre-gestational diabetes Live singleton fetus
Exclusion criteria:
Heart, liver, thyroid diseases, history of asthma Aspirin sensitivity Threatened abortion such as vaginal bleeding Eclampsia and pre-eclampsia at the time of study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
We will construct 6 blocks in AABB, BBAA, ABAB, BABA, ABBA, and BAAB using four blocks. We will assign 1 to 6 for each block. Then, using the random number table, based on the sample size, 15 units of 4 blocks will be selected so that we consider having 30 people in the group (A) and 30 people in the group (B). Therefore, we will do block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug packaging is coded. So that the evaluators and patients are unaware of the drug content packaging and intervention that they receive.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2022-04-25, 1401/02/05
Ethics committee reference number
IR.SEMUMS.REC.1401.018

Health conditions studied

1

Description of health condition studied
High risk pregnancy
ICD-10 code
O09
ICD-10 code description
Supervision of high risk pregnancy

Primary outcomes

1

Description
Vascular Resistance Index (RI)
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
Color Doppler ultrasound

2

Description
Pulsatile index (PI)
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
Color Doppler ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group; Treatment with oral aspirin tablets (Cardiosprin 80 grams, manufactured by Samisaz, Iran) on a daily basis from the 12th week of pregnancy to the 36th week; Together with vaginal progesterone suppositories (Cyclogest 400 mg, manufactured by Octoverco, Iran) daily from the 12th week of pregnancy to the 34th week.
Category
Diagnosis

2

Description
Control group: In this group; Treatment with oral aspirin tablets (Cardiopirin 80 grams, manufactured by Samisaz Company, Iran) is performed daily from the 12th week of pregnancy to the 36th week.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Satinik Darzi
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Satinik Darzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Satinik Darzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Satinik Darzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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