Clinical trial, with parallel groups, double-blind, randomized, phase 2 on 150 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study will be conducted in Hajar Shahrekord Hospital in the population of primiparous mothers with term pregnancy. In this study, the participants will be randomly divided into 3 groups and will be treated with dexamethasone in the first group, hyoscine in the second group, and both in the third group. In this study, the person responsible for data collection and the patient were blinded to the method of intervention.
Participants/Inclusion and exclusion criteria
This study will be conducted on primiparous women with singleton pregnancy and full term, and women with a history of illness or infertility will not be included in the study.
Intervention groups
There are 3 study groups in this study. The first group was treated with dexamethasone, the second group was treated with hyoscine, and the third group was treated with both drugs.
Main outcome variables
The duration of the first and second phases of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240222061084N1
Registration date:2024-03-23, 1403/01/04
Registration timing:retrospective
Last update:2024-03-23, 1403/01/04
Update count:0
Registration date
2024-03-23, 1403/01/04
Registrant information
Name
Saba Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 019 9657
Email address
hnajafi_d@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
2023-04-21, 1402/02/01
Actual recruitment end date
2023-09-23, 1402/07/01
Trial completion date
empty
Scientific title
Investigating the effect of injectable hyoscine and dexamethasone on cervical preparation in primiparous women with term pregnancy
Public title
hyoscine and dexamethasone on cervical preparation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous
Singelton
Term pregnancy
Exclusion criteria:
History of infertility
Cord prolapse
Placenta decollement
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study will be simple. At first, a number of random numbers between 0 and 1 will be generated according to the desired sample size using the function of the Excel program. The generated numbers will be placed in sealed envelopes. In order of entry of the participants, an envelope will be opened and a random number will be seen. If this number is between 0 and 0.333, the person is in the first group, if it is between 0.334 and 0.667, the person is in the second group, and if the number is between 0.668 and 1, the person is in the third group. This process will continue until the required number for each group is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The data collector and the patient are blinded. The collecting person will only provide clinical care and is not aware of the patients' files and the type of medicine received. The patient is also aware of participating in the study, but is unaware of the type of intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahrekord University of Medical Sciences
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2022-12-22, 1401/10/01
Ethics committee reference number
IR.SKUMS.MED.REC.1401.036
Health conditions studied
1
Description of health condition studied
cervical ripening
ICD-10 code
O26
ICD-10 code description
Maternal care for other conditions predominantly related to pregnancy
Primary outcomes
1
Description
duration of first and second labor phase
Timepoint
During Labor
Method of measurement
by the concerned resident with physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, the amount of 8 mg (equivalent to 2 cc) of dexamethasone (manufactured by Iran Hormon Company/Iran) intravenously.
Category
Treatment - Drugs
2
Description
Intervention group: The second group recieve 20 mg of hyoscine butyl bromide manufactured by Exir company, Iran
Category
Treatment - Drugs
3
Description
Intervention group: The third group injected an amount of 8 mg (equivalent to 2 cc) of intravenous dexamethasone (manufactured by Iran Hormon Company) along with 20 mg of intravenous hyoscine butyl bromide (manufactured by Exir Company).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Saba Najafi
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 914 019 9657
Email
njfi.saba@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeesi
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 914 019 9657
Email
njfi.saba@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Saba Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
njfi.saba@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saba Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
njfi.saba@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Saba Najafi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
njfi.saba@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD