Comparison of the effect of intra cervical Foley Catheter without traction and Dilapan-S on second trimester induced abortion: a randomized controlled trial
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General information
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The English spelling of words was corrected
The English spelling of words was corrected
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املای انگلیسی لغات اصلاح شد
املای انگلیسی لغات اصلاح شد
Comparison of the effectiveness of intra cervical Foley Catheter without traction and Dilapan-S in second trimester induction abortion: a randomized controlled trial
Comparison of the effect of intra cervical Foley Catheter without traction and Dilapan-S on second trimester induced abortion: a randomized controlled trial
Comparison of the effectivenesseffect of intra cervical Foley Catheter without traction and Dilapan-S inon second trimester inductioninduced abortion: a randomized controlled trial
Recruitment centers
#1
Name of recruitment center - English: Dr Ganjavian Hospital
Name of recruitment center - Persian: بیمارستان دکتر گنجویان
Full name of responsible person - English: Fatemeh yoosefi
Full name of responsible person - Persian: فاطمه یوسفی
Street address - English: Azadegan Blvd, Dezful Town
Street address - Persian: دزفول، بلوار آزادگان
City - English: Dezful
City - Persian: دزفول
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6461669969
Phone: +98 61 4242 8717
Fax:
Email: Salimeh268@gmail.com
Web page address:
Name of recruitment center - English: Dr Ganjavian Hospital
Name of recruitment center - Persian: بیمارستان دکتر گنجویان
Full name of responsible person - English: Fatemeh Yoosefi
Full name of responsible person - Persian: فاطمه یوسفی
Street address - English: Azadegan Blvd, Dezful Town
Street address - Persian: دزفول، بلوار آزادگان
City - English: Dezful
City - Persian: دزفول
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6461669969
Phone: +98 61 4242 8717
Fax:
Email: Salimeh268@gmail.com
Web page address:
Name of recruitment center - English: Dr Ganjavian Hospital Name of recruitment center - Persian: بیمارستان دکتر گنجویان Full name of responsible person - English: Fatemeh yoosefiYoosefi Full name of responsible person - Persian: فاطمه یوسفی Street address - English: Azadegan Blvd, Dezful Town Street address - Persian: دزفول، بلوار آزادگان City - English: Dezful City - Persian: دزفول Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6461669969 Phone: +98 61 4242 8717 Fax: Email: Salimeh268@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Neda torabi far
Full name of responsible person - Persian: ندا ترابی فر
Street address - English: Azadegan blvd
Street address - Persian: بلوار آزادگان
City - English: Dezful
City - Persian: دزفول
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6461669969
Phone: +98 61 4242 8717
Fax:
Email: Salimeh268@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Neda Torabifar
Full name of responsible person - Persian: ندا ترابی فر
Street address - English: Azadegan blvd
Street address - Persian: بلوار آزادگان
City - English: Dezful
City - Persian: دزفول
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6461669969
Phone: +98 61 4242 8717
Fax:
Email: Salimeh268@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Neda torabi farTorabifar Full name of responsible person - Persian: ندا ترابی فر Street address - English: Azadegan blvd Street address - Persian: بلوار آزادگان City - English: Dezful City - Persian: دزفول Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6461669969 Phone: +98 61 4242 8717 Fax: Email: Salimeh268@gmail.com Web page address:
Protocol summary
Study aim
Comparison of the effectiveness of cervical Catheter without traction and Dilapan-S at the gestational age of 12 to 20 weeks in patients referred to Dr. Ganjovian Hospital for abortion treatment.
Design
A randomized controlled clinical trial, with a parallel group design of 150 patients
Settings and conduct
The participants will be 150 women with a gestational age of 12 to 20 weeks referring to Ganjovian Hospital for abortion treatment. The sample members will be divided in a block randomIzation method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age, over 18 years old 2. Gestational age 12 to 20 weeks 3. Having two ultrasounds indicates the Intrauterine Fetal Death or having a forensic medicine license for abortion 4. Having placental adhesion ultrasound in people with cesarean section‘s history. exclusion criteria: 1. Acute liver or kidney disease 2. History of caesarean section more than twice 3. History of surgery for uterine fibroids 4. Hemoglobin level less than 10 at the beginning of the study 5. Coagulopathy 6. Having a known allergy to misoprostol 7. Impossibility of using a cervical Catheter or dilapan
Intervention groups
In the first group, before applying misoprostol, a cervical catheter is placed in the cervix without tension. in the second group, a Dilapen S is placed in cervix. in the third group, Misoprostol is prescribed alone.
Main outcome variables
The duration of cervical repening until Discharge of abortion products
General information
Reason for update
The English spelling of words was corrected
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051312N2
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-21, 1401/12/02
Update count:5
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Salimeh Moradinasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 8477
Email address
moradi.sal@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intra cervical Foley Catheter without traction and Dilapan-S on second trimester induced abortion: a randomized controlled trial
Public title
Comparison of the effectiveness of cervical Foley Catheter without traction and Dilapan-S on induction of second trimester abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 12 and 20 weeks
over 18 years old
Having two ultrasounds indicating the Intrauterine Fetal Death or having a forensic medicine license for abortion
Having placental adhesion ultrasound in people with cesarean section‘s history
Exclusion criteria:
Acute liver or kidney disease
History of caesarean section more than twice
History of surgery for uterine fibroids
Hemoglobin level less than 10 at the beginning of the study
Coagulopathy
Having a known allergy to misoprostol
Impossibility of using a cervical Catheter or dilapan
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, convenience sampling method and random allocation software will be used for randomization. According to the sample size (150 people), 25 blocks of 6 people will be considered. In this method, 25 blocks of all possible combinations (AABBBCC, ABCABC, ABABCC, BBAACC, CCBBAA, AABCBC, etc.) are created, then these blocks are inserted on opaque and sealed envelopes and randomly selected and back The heads will be placed in a box and the participants will take each envelope and thus divide it into three groups A (cervical catheter without tension), group B (dilapan) and group C (misoprostol).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Dezful University of Medical Sciences
Street address
Azadegan Blvd, Dezful
City
Dezful
Province
Khouzestan
Postal code
6461669969
Approval date
2022-01-09, 1400/10/19
Ethics committee reference number
IR.DUMS.REC.۱۴۰۰.۰۴۹
Health conditions studied
1
Description of health condition studied
Second trimester abortion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The time needed for expulsion of products of gestation
Timepoint
Every 30 minutes
Method of measurement
Physical exam
Secondary outcomes
1
Description
The interval between the insertion of the catheter and expulsion of the pregnancy's products
Timepoint
Every 30 minutes
Method of measurement
Physical exam
2
Description
The interval between the insertion of Dilapan-s and expulsion of the pregnancy's products
Timepoint
Every 30 minutes
Method of measurement
Physical exam
3
Description
Hemoglobin level
Timepoint
At admission and 6 hours after expulsion
Method of measurement
Lab test
Intervention groups
1
Description
Intervention group: Sublingual Misoprostol. Two doses of misoprostol (200 micrograms) are prescribed every three hours, Maximum 5 doses. (According to the International Federation of Gynecology and Obstetrics protocol)
Category
Treatment - Other
2
Description
Intervention group: Dilapan-s (mechanical cervical dilator). A Dilapan-S (3x55mm) is inserted into the cervix, 4-6 hours later, Two doses of misoprostol (200 micrograms) are prescribed every three hours, Maximum 5 doses.
Category
Treatment - Devices
3
Description
Intervention group: intra cervical Foley Catheter without traction. The patient is placed in the lithotomy position, after placing the speculum and cleaning the cervix with betadine solution, a Foley 14 catheter is inserted into the endocervical canal (Supa medical devices, Tehran, Iran) and placed in the inner opening of the cervix and filled with 40 cc of normal saline. then we fix the end of the catheter to the inner surface of the thigh with glue
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Ganjavian Hospital
Full name of responsible person
Fatemeh Yoosefi
Street address
Azadegan Blvd, Dezful Town
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 8717
Email
Salimeh268@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Neda Torabifar
Street address
Azadegan blvd
City
Dezful
Province
Khouzestan
Postal code
6461669969
Phone
+98 61 4242 8717
Email
Salimeh268@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dezfoul 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
Dezfoul University of Medical Sciences
Full name of responsible person
Salimeh Moradinasab
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 10, Vahed Ave., Golestan Street., Dezful Town
City
Dezful
Province
Khouzestan
Postal code
6461657514
Phone
+98 61 4242 8477
Email
Salimeh268@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Salimeh Moradinasab
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 10, Vahed Ave., Golestan Blvd., Dezful Town
City
Dezful
Province
Khouzestan
Postal code
6461657514
Phone
+98 61 4242 8477
Email
Salimeh268@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Dezfoul University of Medical Sciences
Full name of responsible person
Salimeh Moradinasab
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 10, Vahed Ave., Golestan Street., Dezful Town
City
Dezful
Province
Khouzestan
Postal code
6461657514
Phone
+98 61 4242 8477
Email
Salimeh268@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
Not applicable
Title and more details about the data/document
The whole data will be shareable after being unidentifiable
When the data will become available and for how long
Access period will be 6 months after publishing the results
To whom data/document is available
Data will be accessible for all researchers, students and professors in all medical schools over the country
Under which criteria data/document could be used
Data will be available for research use if approved by the project principals