Comparison of the effect of vaginal progesterone on uterine Doppler findings in early-onset preeclampsia
Design
This study was designed as a single-blinded randomized clinical trial with parallel groups and a sample size of40 people in each group.
Settings and conduct
The study will be conducted at Kamali Hospital on pregnant women. Patients who signed informed consent will be randomly divided into two groups. The first group will receive progesterone suppository 200 mg daily for one week. The control group will not receive an intervention The final outcome of the study will be assessed by a third party who is unaware of the study process. Also, the statistician will be unaware of the study process
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age between 24-32 weeks; Increased uterine artery resistance; Single pregnancy; Patients with a history of lupus antiphospholipid syndrome; History of high blood pressure; Previous history of preeclampsia; Diabetic
Exclusion criteria: Having kidney, liver, and heart disease;e Having progesterone sensitivity Having severe preeclampsia Rupture of membranes; Patients with cardiomyopathy; Evidence of fetal growth retardation; Ultrasound evidence of life-threatening congenital anomalies; Use assisted reproductive techniques such as IVF
Intervention groups
Intervention group: Progesterone suppository 200 mg daily for one week
Control group: Without intervention
Main outcome variables
Uterine artery Doppler resistance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210127050156N1
Registration date:2021-03-03, 1399/12/13
Registration timing:prospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Masoumeh Farahani
Name of organization / entity
The Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 5627
Email address
m.farahanii@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-20, 1399/12/30
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vaginal progesterone on uterine Doppler findings in early-onset preeclampsia
Public title
Comparison of the effect of vaginal progesterone on uterine Doppler findings in early-onset preeclampsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age between 24-32 weeks
Increased uterine artery resistance
Single pregnancy
Patients with a history of lupus antiphospholipid syndrome
History of high blood pressure
Previous history of preeclampsia
Diabetic
Exclusion criteria:
Having kidney, liver and heart disease
Having progesterone sensitivity
Having severe preeclampsia
Rupture of membrance
Patients with cardiomyopathy;
Evidence of fetal growth retardation;
Ultrasound evidence of life-threatening congenital anomalies
Use assisted reproductive techniques such as IVF
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
First, this study is done as a pilot, and then, based on the results, the sample size is determined. Simple randomization approach will be implemented in this study. Randomization will be performed using a computer-generated list. For this purpose, 80 sealed envelopes will be numbered 1-80 according to the randomization list. Group allocation will be kept separate until the study is completed. The randomization ratio would be 1: 1, with 40 envelopes allocated to each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. Due to the type of intervention, participants are aware of the type of treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Tehran
Province
Tehran
Postal code
3149779453
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.ABZUMS.REC.1399.245
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Uterine artery resistance
Timepoint
Before and one week after the intervention
Method of measurement
Doppler ultrasound
2
Description
Symptoms of preeclampsia
Timepoint
During pregnancy
Method of measurement
Doctor's opinion
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Progesterone vaginal suppository 200 mg (Aburaihan pharmaceutical company) every night for one week
Category
Treatment - Drugs
2
Description
Control group: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Masoomeh Farahani
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Tehran
Province
Tehran
Postal code
3149779453
Phone
+98 26 3222 2021
Email
m.farahanii@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Nourisepehr
Street address
Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Masoomeh Farahani
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
m.farahanii@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Masoomeh Farahani
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
m.farahanii@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Masoomeh Farahani
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kamali hospital; Kamali alley; Shohada square; Shahid Beheshti street
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3222 2021
Email
m.farahanii@abzums.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