Determining the comparative effect of dydrogesterone and progesterone in preventing premature birth in women with short cervix
Design
Clinical trial with control group, with parallel group, double blind, randomized, phase 3 on 64 patients. Block randomization using block of four
Settings and conduct
The study is conducted in Sayadshirazi Hospital, Gorgan. Patients with a minimum gestational age of 18 weeks and a cervix length of less than 25 mm are randomly classified into two groups.The dydrogesterone group(32 people) will receive oral medication, 30 mg of dydrogesterone tablets and a similar placebo suppository (glycerin suppository vaginally).The vaginal progesterone group received one 400 mg vaginal progesterone suppository and three similar oral placebo pills (vitamin B6) daily.
Participants/Inclusion and exclusion criteria
Entering Criteria:
Cervical length less than 25 mm, measured by TVS
Singleton pregnancy
Refer to the center between 6 and18 weeks of pregnancy
Any evidence of threatened abortion in the first half of pregnancy
Exit criteria:
Multiple pregnancy
Any uncontrolled systemic diseases
History of consuming alcoholic beverages or drug or drug abuse
Absence of gestational sac in the fifth week
Lack of yolk sac in 5.5 to 6 weeks of pregnancy
Absence of fetus in 6-6.5 weeks of pregnancy
Absence of fetal heartbeat in weeks 16 to 24
Having a history of preterm delivery and cervical surgery
Having a pair of umbilical cords confirmed by transvaginal ultrasound
Intervention groups
An oral dydrogesterone group will receive a daily 30 mg dydrogesterone tablet and a similar placebo suppository. The vaginal progesterone group will receive a daily 400 mg vaginal progesterone suppository suppository and a similar placebo oral tablet.
Main outcome variables
Preterm labour
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221107056426N1
Registration date:2022-11-14, 1401/08/23
Registration timing:registered_while_recruiting
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
mahboobeh khajehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 1722
Email address
mahboobkhajepour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-08, 1401/08/17
Expected recruitment end date
2023-11-08, 1402/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Dydrogesterone and Progesterone in prevention of preterm birth in women with a short cervix
Public title
Efectiveness of dydrogesterone and progesterone in prevention of preterm birth in women with a short cervix
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cervical length less than 25 mm, measured by transvaginal ultrasound
Singleton pregnancy
Refer to the center at the age of pregnancy between 6 and 18 weeks
Any evidence of threatened abortion( vaginal bleeding and bloody vaginal discharge) in the first half of pregnancy
Willingness and written consent to enter the study
Follow-up and regular referrals for pregnancy care
Exclusion criteria:
Multiple pregnancy
Any uncontrolled systemic disease(diabete, blood pressure, kidney, liver, etc.)
History of consuming alcoholic beverages or drug or drug abuse
Absence of gestational sac in the fifth week
Lack of yolk sac in 5.5 to 6 weeks of pregnancy
Absence of fetus in 6-6.5 weeks of pregnancy
Absence of fetal heartbeat in weeks 16 to 24
Having a history of preterm delivery
Having a pair of umbilical cords confirmed by transvaginal ultrasound
History of surgery on the cervix
Fetal and uterine anomalies
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the samples, we use the block method with blocks of four. In this way, one of the following blocks is first chosen randomly (for example, with a dice) and according to the order of that, the samples are assigned to two groups. (A for the oral dydrogesterone group and B for the progesterone group (for example, if block three is selected and the first sample will be assigned to the group receiving dydrogesterone, the second and third samples will be assigned to the progesterone group, and the fourth sample will be assigned to the group receiving dydrogesterone. For the next four samples, we will randomly select a block again and perform the allocation according to it, and this process will continue until the end of the sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding process is done in such a way that one group receives 3 oral pills of 10 mg of Dydrogesterone and a placebo vaginal suppository similar to vaginal progesterone, and the other group receives 3 oral placebo pills similar to Dydrogesterone in terms of size, color and shape, which is a complication for the mother and does not have a fetus, they are studied by uninformed people along with vaginal progesterone
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gorgan University of Medical Sciences
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services، Hirkan Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2022-10-16, 1401/07/24
Ethics committee reference number
IR.GOUMS.REC.1401.348
Health conditions studied
1
Description of health condition studied
Preterm labour
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
Cervical length
Timepoint
1, 5, 9 weeks after starting treatment and immediately after delivery
Method of measurement
Vaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vaginal progesterone group, daily one suppository of 400 mg of vaginal progesterone suppository and three oral pills of the same placebo (vitamin B6)
Category
Prevention
2
Description
Control group: The oral dydrogesterone group will receive 30 mg of dydrogesterone tablets and a similar placebo suppository (vaginal glycerin suppository).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan Shahid sayad shirazi hospital
Full name of responsible person
Mahboobeh Khajehpour
Street address
Shahid sayad shirazi Blv
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1502
Email
Mahboobkhajepour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beigom mirbehbahani
Street address
Central Organization of Golestan University of Medical Sciences and Healthcare Services, Hirkan Blv, Gorgan
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3243 0310
Email
Mahboobkhajepour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Mahboobeh Khajehpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 42, Alley 54, Shahid Mostafa Khomeini Street
City
Kerman
Province
Kerman
Postal code
7617657189
Phone
0098 43 32131722
Email
Mahboobkhajepour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahboobeh Khajehpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No42, Alley54, Shahid Mostafa Khomeini street
City
Kerman
Province
Kerman
Postal code
7617657189
Phone
0098 43 32131722
Email
Mahboobkhajepour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mahboobeh Khajehpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 42, Alley 54, Shahid Mostafa Khomeini Street
City
Kerman
Province
Kerman
Postal code
7617657189
Phone
0098 43 32131722
Email
Mahboobkhajepour@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
Information on the main outcome
When the data will become available and for how long