Protocol summary
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Study aim
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Comparison of the efficacy of vaginal isoniazid with sublingual misoprostol and sublingual misoprostol alone in inducing abortion during the first three months of pregnancy
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Design
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A randomized controlled clinical trial with parallel groups, without blinding
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Settings and conduct
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In the first group vaginal isoniazid (mg 1500) is placed and 12 hours later sub-lingual misoprostol (800 μg) administered. In the absence of vaginal bleeding or pain, repeat up to 3 doses every 3 hours. In second Group, they receive only the second vaginal misoprostol. After the first dose of misoprostol, abortion was considered successful within 24 hours after ablation, and vaginal ultrasound will be performed to check for residuals. In the absence of residuals, "complete abortion" is reported. In cases of residues below 3 cm, "successful disposal" and "incomplete abortion" are reported. Misoprostol 800μg should be used again every three hours for up to three doses if residuals above 3 cm, failure to excretion, or visualization of pregnancy sacs. At the end of the second 24 hours, vaginal ultrasound was performed to examine the remains. Patients were divided into one of the following groups based on the interval between the onset of misoprostol and the expulsion of the tissue that is considered as successful treatment:
Abortion under 6 hours
Abortion under 12 hours
Abortion under 24 hours
Abortion under 48 hours
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Participants/Inclusion and exclusion criteria
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All Grade One pregnant women with no vaginal bleeding and whole package with gestational age less than or equal to 91 days based on LMP and ultrasound (blighted ovum, missed abortion, legal abortion) and are candidates for termination of pregnancy or have a forensic abortion permit are enrolled in the study.
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Intervention groups
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The intervention group received isoniazid plus misoprostol
The control group received only misoprostol.
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Main outcome variables
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abortion
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190819044561N1
Registration date:
2020-02-19, 1398/11/30
Registration timing:
retrospective
Last update:
2021-12-01, 1400/09/10
Update count:
1
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Registration date
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2020-02-19, 1398/11/30
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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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2018-04-21, 1397/02/01
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Expected recruitment end date
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2019-09-21, 1398/06/30
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Actual recruitment start date
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2018-04-21, 1397/02/01
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Actual recruitment end date
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2019-09-21, 1398/06/30
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Trial completion date
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2019-09-21, 1398/06/30
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Scientific title
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A comparison between the effect of Isoniazid together with Misoprostol and Misoprostol on abortion in the first three months of pregnancy.
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Public title
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A comparison between the effect of Isoniazid together with Misoprostol and Misoprostol on abortion in the first three months of pregnancy.
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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 less than 13 weeks
Primigravida
Without vaginal bleeding
Closed cervical os
Candidate for pregnancy termination
Exclusion criteria:
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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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3
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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:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Blocked randomization
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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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2018-04-16, 1397/01/27
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Ethics committee reference number
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IR.IUMS.FMD.REC.1396.9511290012
Health conditions studied
1
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Description of health condition studied
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Abortion
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ICD-10 code
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0o3
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ICD-10 code description
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Miscarriage
Primary outcomes
1
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Description
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Abortion Time
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Timepoint
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During the intervention
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Method of measurement
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hour
Secondary outcomes
1
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Description
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Vomit
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Timepoint
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During the intervention
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Method of measurement
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See
2
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Description
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Diarrhea
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Timepoint
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During the intervention
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Method of measurement
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see
3
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Description
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Fever
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Timepoint
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During the intervention
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Method of measurement
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Celsius
Intervention groups
1
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Description
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Intervention group: First, 1500 mg of vaginal isoniazid is administered, and then 12 hours later, 800 micrograms of sub-lingual misoprostol.Repeat every three hours to three doses.
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Category
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Treatment - Drugs
2
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Description
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Control group: Only 800 μg of sublingual misoprostol was given every 3 hours up to 3 doses.
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Category
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Treatment - Drugs
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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Iran 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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Not applicable
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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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No - There is not a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as information about the main outcome or the like, can be shared.
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When the data will become available and for how long
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Start of access period 12 months after publishing results
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To whom data/document is available
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Gynecologists
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Under which criteria data/document could be used
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Use of data and documentation is permitted by mentioning the source name.
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From where data/document is obtainable
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Dr Mahshid Shirvani
shirvani.mahshid777@gmail.com
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What processes are involved for a request to access data/document
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After contacting Dr. Shirvani if your request complies with study policies, the data will be available to you.
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Comments
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