Protocol summary
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Study aim
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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.
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Design
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A randomized controlled clinical trial, with a parallel group design of 90 patients
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Settings and conduct
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The participants will be 90 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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The duration of cervical repening until Discharge of abortion products
General information
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Reason for update
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The Persian title was corrected
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210516051312N2
Registration date:
2023-02-12, 1401/11/23
Registration timing:
registered_while_recruiting
Last update:
2024-04-25, 1403/02/06
Update count:
5
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Registration date
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2023-02-12, 1401/11/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-11, 1400/12/20
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Expected recruitment end date
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2023-07-11, 1402/04/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Comparison of the effectiveness of cervical Foley Catheter without traction and Dilapan-S on induction of second trimester abortion
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, convenience sampling method and random allocation software will be used for randomization. the sample size (90 people) based on previous study will be considered. To conceal the allocation sequence, the papers identifying the group of individuals in the order of the generated allocation sequence were placed in closed envelopes and coded in the same order from 1 to 90. Eventually three groups of 30 patients including group A(cervical catheter without tension), group B(dilapan) and group C(misoprostol) will be randomly selected in this study.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-01-09, 1400/10/19
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Ethics committee reference number
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IR.DUMS.REC.۱۴۰۰.۰۴۹
Health conditions studied
1
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Description of health condition studied
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Second trimester abortion
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The time needed for expulsion of products of gestation
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Timepoint
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Every 30 minutes
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Method of measurement
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Physical exam
Secondary outcomes
1
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Description
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The interval between the insertion of the catheter and expulsion of the pregnancy's products
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Timepoint
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Every 30 minutes
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Method of measurement
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Physical exam
2
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Description
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The interval between the insertion of Dilapan-s and expulsion of the pregnancy's products
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Timepoint
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Every 30 minutes
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Method of measurement
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Physical exam
3
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Description
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Hemoglobin level
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Timepoint
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At admission and 6 hours after expulsion
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Method of measurement
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Lab test
Intervention groups
1
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Description
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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)
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Devices
3
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Description
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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_16 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
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Dezfoul University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The whole data will be shareable after being unidentifiable
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When the data will become available and for how long
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Access period will be 6 months after publishing the results
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To whom data/document is available
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Data will be accessible for all researchers, students and professors in all medical schools over the country
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Under which criteria data/document could be used
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Data will be available for research use if approved by the project principals
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From where data/document is obtainable
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Tel: 00986142428717 email: fatemehyousefi135926@gmail.com
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What processes are involved for a request to access data/document
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Agreement of project managers and the research center
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Comments
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