Protocol summary
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Study aim
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Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
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Design
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clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 40 patients
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Settings and conduct
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Eligible patients entering the study referred to Imam Sajjad Hospital of Yasuj University of Medical Sciences will be divided into two groups of 20 people and the consequences of abortion will be measured.
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Participants/Inclusion and exclusion criteria
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Uterine size in proportion to gestational age on clinical examination
Candidates for termination of pregnancy for reasons such as missed abortion, blighted ovum, or fetal death can be confirmed by two ultrasounds.
Age between 18 to 45 years
Gestational age less than 12 weeks gestation
No contraindication to use of misoprostol
No history of uterine pathology ultrasound findings
No mole pregnancy
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Intervention groups
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Group A: Stachys lavandulifolia extract will be administered in the form of tablets (400 mg every three hours, up to three doses) along with 400 micrograms (up to three doses every three hours). If the fetus is not expelled, the above dose will be repeated on the second day.
In group B: Misoprostol will be prescribed according to the latest national protocol guidelines. In this way, 800 micrograms (four 200 microgram tablets) every three hours, up to three doses) will be used orally. If the fetus is not aborted, the above dose will be repeated on the second day.
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Main outcome variables
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Completed abortion
Incompleted abortion
Hemorrhage
Pain severity
General information
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Reason for update
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Hi
Respectfully recalls the present study entitled "Comparison of the effect of misoprostol in comparison with Stachys lavandulifolia with misoprostol in the success of the first trimester of abortion in patients referred to the maternity ward of Imam Sajjad Hospital in Yasouj in 1398" in the ethics committee of Yasouj University of Medical Sciences was confirmed that the information of the groups was entered incorrectly in the two groups of misoprostol alone and Stachys lavandulifolia alone, which was corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160524028038N7
Registration date:
2020-07-01, 1399/04/11
Registration timing:
registered_while_recruiting
Last update:
2021-04-13, 1400/01/24
Update count:
2
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Registration date
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2020-07-01, 1399/04/11
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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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2020-01-20, 1398/10/30
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Expected recruitment end date
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2021-03-19, 1399/12/29
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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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Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
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Public title
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Misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Uterine size in proportion to gestational age on clinical examination
Candidates for termination of pregnancy for reasons such as missed abortion, blighted ovum, or fetal death can be confirmed by two ultrasounds.
Age between 18 to 45 years
Gestational age less than 12 weeks gestation
No contraindication to use of misoprostol
No history of uterine pathology ultrasound findings
No mole pregnancy
Exclusion criteria:
Unwillingness to participate in the study
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Age
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From 18 years old to 45 years old
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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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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized in 4 blocks; Hiding method: Use envelopes in the package
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The blinding method is patients will not be aware of their allocation to study groups and all medications will be placed into same capsules of size, shape and color by the pharmacist.
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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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2020-01-18, 1398/10/28
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Ethics committee reference number
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IR.YUMS.REC.1398.147
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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O04.8
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ICD-10 code description
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(Induced) termination of pregnancy with other and unspecified complications
Primary outcomes
1
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Description
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Completed abortion
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Timepoint
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After intervention
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Method of measurement
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Symptom
2
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Description
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Incompleted abortion
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Timepoint
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After intervention
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Method of measurement
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Symptom
3
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Description
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Pain severity
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Timepoint
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After intervention
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Method of measurement
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VAS scale
Intervention groups
1
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Description
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Group A: Stachys lavandulifolia extract will be three doses) along with 400 micrograms (up to three doses every three hours). If the fetus is not expelled, the above dose will be repeated on the second day.
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Category
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Treatment - Drugs
2
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Description
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In group B: Misoprostol will be prescribed according to the latest national protocol guidelines. In this way, 800 micrograms (four 200 microgram tablets) every three hours, up to three doses) will be used orally. If the fetus is not aborted, the above dose will be repeated on the second day.
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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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Yasouj 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not 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