A clinical trial with a control group, with parallel groups, concentrated, phase 3 on 42 patients.
For randomization, a random table of numbers is used.
Settings and conduct
Imam Khomeini Hospital, University of Tehran, patients with UCA≥105ᵒ in 18-20 weeks of gestation are randomly selected according to the table. One group was given vaginal progesterone 400 mg daily, and the other group was not given it as a drug control. CL length and UCA change rate are evaluated one month later. Finally, delivery time based on gestational age, need for cerclage, and cervical length change are compared in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. All women aged 18-45, 2. A singleton pregnancy carrier, 3. No history of premature birth
Exclusion criteria: 1. Having a history of premature birth, 2. History of cervical insufficiency and 3. The initial length of the cervix in the initial evaluation of the patient was CL ≤ 30mm , 4. no consent to participate.
Intervention groups
The intervention group was given vaginal progesterone 400 mg daily from 18-20 weeks of pregnancy until 36 weeks of pregnancy, and the control group was not given medication.
Main outcome variables
Preterm delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190208042655N3
Registration date:2024-01-29, 1402/11/09
Registration timing:prospective
Last update:2024-01-29, 1402/11/09
Update count:0
Registration date
2024-01-29, 1402/11/09
Registrant information
Name
Nafiseh Saedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 0727
Email address
nsaedi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of progesterone suppository on reducing the rate of preterm labor in patients with utererocervical angle above 105 °
Public title
Evaluation of progesterone suppository in reducing preterm labor in high uterocervical angle
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All women aged 18-45
A singleton pregnancy carrier
No history of premature birth
Exclusion criteria:
history of preterm labor
history of second-trimester abortion
cervical length below 30 mm
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
According to the table of random numbers, patients are classified into one of two intervention or control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after entering the mentioned study and filling out the informed consent form to participate in the study, and explaining the desired intervention in each group , according to the table of random numbers, the patients are placed in one of the two intervention or control groups. Finally, data analysis will be done by a third person who is completely blinded about the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Sattar Khan Street, Imam Khomeini Hospital Complex, Women's Department
City
tehran
Province
Tehran
Postal code
1597856511
Approval date
2023-08-29, 1402/06/07
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.201
Health conditions studied
1
Description of health condition studied
preterm labor
ICD-10 code
O34.32
ICD-10 code description
Maternal care for cervical incompetence, second trimester
Primary outcomes
1
Description
The effect of progesterone suppositories in reducing premature labor
Timepoint
delivery time
Method of measurement
Investigation of preterm birth under 37 weeks of pregnancy
Secondary outcomes
1
Description
The effect of progesterone suppositories on changing the uterocervical angle one month after receiving suppositories
Timepoint
One month after receiving progesterone suppositories
Method of measurement
with Philips Affinity 70 ultrasound machine and with vaginal probe 1-10
Intervention groups
1
Description
Intervention group: Pregnant women with a uterocervical angle above 105 degrees, receive 400 mg of vaginal progesterone suppositories daily (Aborehan Company) from 18-20 weeks to 36 weeks of pregnancy.
Category
Prevention
2
Description
Control group: Pregnant women with uterocervical angle above 105 degrees and normal cervical length without receiving medication.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Nafiseh Saedi
Street address
sattarkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 912 747 5821
Email
saedi.tums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Nima Rezaee
Street address
sattarkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 912 747 5821
Email
nsaedi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
assistant proffesor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
sattarkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8886 3994
Email
nsaedi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafise Saedi
Position
assistant proffesor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
sattarkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8886 3994
Email
nsaedi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Saedi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
sattarkhan
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8886 3994
Email
saedi.tums@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
All data are available in SPSS file
When the data will become available and for how long
3 months after the publication of the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
If the data is needed and used to provide the proposal to the executor of the project, the right of the executor and the co-author of the project should be respected.
From where data/document is obtainable
Send via email nsaedi@sina.tums.ac.ir request
What processes are involved for a request to access data/document
First, the reason for the request and proposal of the proposed project will be sent to nsaedi@sina.tums.ac.ir address, and then, if the executor agrees, taking into account the agreement between the parties to protect the rights of the executors of the project, it will be sent via email and in the form of SPSS file.