1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of transactional catheter and Extra-Amniotic Normal Saline Infusion (EASI) on cervical readiness in primiparous mothers who are candidates for termination of pregnancy with Bishop score less than 4 4in Ayatollah Mosavi Hospital in Zanjan in 2021-2022

Protocol summary

Study aim
Comparison of the effect of traction catheter and normal amniotic extraction (EASI) on cervical preparation in primiparous mothers candidates for termination of pregnancy
Design
This single-blind randomized clinical trial with parallel groups will be performed on 52 pregnant women. Patients are randomly divided into two groups by block randomization. In patients in EASI group, cervical catheter will be used and in cervical traction catheter group, cervical catheter will be used.
Settings and conduct
This single-blind randomized clinical trial study with parallel groups will be performed on 52 women with a gestational age of 37 weeks and older in Zanjan academic hospital. In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the drug prescribing protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria are gestational age equal to or greater than 37 weeks (based on LMP and first trimester ultrasound), single pregnancy. Patients with a history of previous cesarean section, placenta previa, premature rupture of membranes, and people with preeclampsia will be excluded from the study.
Intervention groups
In EASI patients, 15 cc of normal saline solution is first injected into the cervical catheter balloon and then this infusion is continued at a rate of one milliliter per minute into the extraamniotic space. In the cervical traction catheter group, in the lithotomy position, the cervical catheter No. 24 passes directly throw the inner hole of the cervix and its balloon will be filled with 30 cc of sterile serum.
Main outcome variables
Duration of stages one, two and three of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220403054399N1
Registration date: 2022-04-24, 1401/02/04
Registration timing: prospective

Last update: 2022-04-24, 1401/02/04
Update count: 0
Registration date
2022-04-24, 1401/02/04
Registrant information
Name
fatemeh daraie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
daraie.fatemeh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of transactional catheter and Extra-Amniotic Normal Saline Infusion (EASI) on cervical readiness in primiparous mothers who are candidates for termination of pregnancy with Bishop score less than 4 4in Ayatollah Mosavi Hospital in Zanjan in 2021-2022
Public title
The effect of transactional catheter and Extra-Amniotic Normal Saline Infusion (EASI) on cervical readiness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single tone pregnancy Gestational age more than 37 weeks
Exclusion criteria:
Premature rupture of membranes (PROM) previous cesarean section (CS) Placenta Previa Preeclampsia
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the block randomization method. The size of all blocks is equal. Random allocation software is also used to generate a random sequence of blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data collectors, outcome assessors, and manuscript writers will be completely unaware of the prescribing protocol.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhori BLV. Azadi Squ. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1435689752
Approval date
2022-02-21, 1400/12/02
Ethics committee reference number
IR.ZUMS.REC.1400.502

Health conditions studied

1

Description of health condition studied
labor
ICD-10 code
O60.2
ICD-10 code description
Term delivery with preterm labor

Primary outcomes

1

Description
duration of first stage of labor
Timepoint
Not applicable
Method of measurement
hour

Secondary outcomes

1

Description
Duration of second stage of labor
Timepoint
Not applicable
Method of measurement
Hour

Intervention groups

1

Description
Intervention group: In EASI patients, 15 cc of normal saline solution is first injected into the cervical catheter balloon and then this infusion is continued at a rate of one milliliter per minute into the extraamniotic space.
Category
Treatment - Devices

2

Description
Intervention group: In the cervical traction catheter group, in the lithotomy position, the cervical catheter No. 24 passes directly throw the inner hole of the cervix and its balloon will be filled with 30 cc of sterile serum.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Fatemeh Daraie
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Daraie.Fatemeh@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University of Medical Sciences Campus, Dr. Yousef Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
riasat@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Daraie
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
Zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Daraie.Fatemeh@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Daraie
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Daraie.Fatemeh@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Daraie
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi Hospital, Gavazang Road, Zanjan
City
zanjan
Province
Zanjan
Postal code
1425678922
Phone
+98 21 8806 4148
Email
Daraie.Fatemeh@zums.ac.ir

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
Part of the data including the main and secondary outcomes can be shared.
When the data will become available and for how long
Access period starts from 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals.
From where data/document is obtainable
Contact the research expert of the Infertility Clinic of Zanjan University to receive the required documents or data.
What processes are involved for a request to access data/document
To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her.
Comments
Loading...