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Protocol summary
Evaluation of the effect of Stachys lavandulifolia on the rate of abortion in the first trimester compared with misoprostol
Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester compared with misoprostol
بررسی اثر چاي كوهي در موفقيت سقط سه ماهه اول در مقايسه با ميزوپروستول
بررسی اثر میزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقیت سقط سه ماهه اول بارداری
بررسی اثر چاي كوهيمیزوپروستول در موفقيتمقایسه با میزوپروستول به همراه چای کوهی در موفقیت سقط سه ماهه اول در مقايسه با ميزوپروستولبارداری
Group A: Stachys lavandulifolia extract in the amount of 12 mg / kg syrup will be prescribed to patients at intervals of three hours. If the fetus is not aborted, 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) will be used orally. If the fetus is not aborted, the above dose will be repeated on the second day.
Group A: Stachys lavandulifolia extract will be administered in the form of tablets (200 mg every three hours, up to two doses) along with 400 micrograms (up to two 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.
Group A: Stachys lavandulifolia extract will be administered in the amountform of 12tablets (200 mg / kg syrup will be prescribed to patients at intervals ofevery three hours, up to two doses) along with 400 micrograms (up to two doses every three hours). If the fetus is not abortedexpelled, 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.
گروه A: عصاره چای کوهی به میزان12mg/kg بصورت شربت به بیماران گروه چای کوهی در فواصل سه ساعت تجویز خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروهB: ميزو پروستول طبق آخرين دستورالعمل پروتكل كشوري تجويز خواهد گرديد. بدین روش که 800 میکروگرم ( چهار عدد قرص 200 میکروگرم) بصورت خوراکی در استفاده خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروه A: عصاره چای کوهی بصورت قرص (200 میلی گرم هر سه ساعت، تا دو دوز ) به همراه 400 میکروگرم ( هر سه ساعت تا دو دوز) تجویز خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروهB: ميزو پروستول طبق آخرين دستورالعمل پروتكل كشوري تجويز خواهد گرديد. بدین روش که 800 میکروگرم ( چهار عدد قرص 200 میکروگرم) بصورت خوراکی هر سه ساعت( تا سه دوز) استفاده خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروه A: عصاره چای کوهی به میزان12mg/kg بصورت شربت به بیماران گروه چای کوهی در فواصلقرص (200 میلی گرم هر سه ساعت، تا دو دوز ) به همراه 400 میکروگرم ( هر سه ساعت تا دو دوز) تجویز خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید. گروهB: ميزو پروستول طبق آخرين دستورالعمل پروتكل كشوري تجويز خواهد گرديد. بدین روش که 800 میکروگرم ( چهار عدد قرص 200 میکروگرم) بصورت خوراکی درهر سه ساعت( تا سه دوز) استفاده خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
General information
Used
Not used
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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.
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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با سلام
احتراما به استحضار میرساند طرح حاضر با عنوان "مقایسه ی اثر میزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقیت سقط سه ماهه ی اول بارداری در بیماران مراجعه کننده به زایشگاه بیمارستان امام سجاد شهر یاسوج در سال 1398" درکمیته اخلاق دانشگاه علوم پزشکی یاسوج مصوب گردیده بوده است که اطلاعات گروه ها به اشتباه در دو گروه میزوپروستول به تنهایی و چای کوهی به تنهایی وارد گردیده بود که تصحیح گردید.
با سلام احتراما به استحضار میرساند طرح حاضر با عنوان "مقایسه ی اثر میزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقیت سقط سه ماهه ی اول بارداری در بیماران مراجعه کننده به زایشگاه بیمارستان امام سجاد شهر یاسوج در سال 1398" درکمیته اخلاق دانشگاه علوم پزشکی یاسوج مصوب گردیده بوده است که اطلاعات گروه ها به اشتباه در دو گروه میزوپروستول به تنهایی و چای کوهی به تنهایی وارد گردیده بود که تصحیح گردید.
Stachys lavandulifolia on the rate of abortion in the first trimester compared with misoprostol
Misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
Misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester compared with misoprostol
چاي كوهي در موفقيت سقط سه ماهه اول در مقايسه با ميزوپروستول
میزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقيت سقط سه ماهه اول
چاي كوهيمیزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقيت سقط سه ماهه اول در مقايسه با ميزوپروستول
Evaluation of the effect of Stachys lavandulifolia on the rate of abortion in the first trimester compared with misoprostol
Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester compared with misoprostol
بررسی اثر چاي كوهي در موفقيت سقط سه ماهه اول در مقايسه با ميزوپروستول
بررسی اثر میزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقيت سقط سه ماهه اول
بررسی اثر چاي كوهيمیزوپروستول در مقایسه با میزوپروستول به همراه چای کوهی در موفقيت سقط سه ماهه اول در مقايسه با ميزوپروستول
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use envelopes in the package
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
Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software; Sequence Building: Using randomized 4 in 4 blocks; Hiding method: Use envelopes in the package
Intervention groups
#1
Group A: Stachys lavandulifolia extract in the amount of 12 mg / kg syrup will be prescribed to patients at intervals of three hours. If the fetus is not aborted, the above dose will be repeated on the second day.
Group A: Stachys lavandulifolia extract will be administered in the form of tablets (200 mg every three hours, up to two doses) along with 400 micrograms (up to two doses every three hours). If the fetus is not expelled, the above dose will be repeated on the second day.
Group A: Stachys lavandulifolia extract will be administered in the amountform of 12tablets (200 mg / kg syrup will be prescribed to patients at intervals ofevery three hours, up to two doses) along with 400 micrograms (up to two doses every three hours). If the fetus is not abortedexpelled, the above dose will be repeated on the second day.
گروه A: عصاره چای کوهی به میزان12mg/kg بصورت شربت به بیماران گروه چای کوهی در فواصل سه ساعت تجویز خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروه A: عصاره چای کوهی بصورت قرص (200 میلی گرم هر سه ساعت، تا دو دوز ) به همراه 400 میکروگرم ( هر سه ساعت تا دو دوز) تجویز خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروه A: عصاره چای کوهی به میزان12mg/kg بصورت شربت به بیماران گروه چای کوهی در فواصلقرص (200 میلی گرم هر سه ساعت، تا دو دوز ) به همراه 400 میکروگرم ( هر سه ساعت تا دو دوز) تجویز خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
#2
Group B: Misoprostol will be prescribed according to the latest national protocol guidelines. In this way, 800 micrograms (four 200 microgram tablets) will be used orally. If the fetus is not aborted, 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.
GroupIn 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.
گروهB: ميزو پروستول طبق آخرين دستورالعمل پروتكل كشوري تجويز خواهد گرديد. بدین روش که 800 میکروگرم ( چهار عدد قرص 200 میکروگرم) بصورت خوراکی در استفاده خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروهB: ميزو پروستول طبق آخرين دستورالعمل پروتكل كشوري تجويز خواهد گرديد. بدین روش که 800 میکروگرم ( چهار عدد قرص 200 میکروگرم) بصورت خوراکی هر سه ساعت( تا سه دوز) استفاده خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
گروهB: ميزو پروستول طبق آخرين دستورالعمل پروتكل كشوري تجويز خواهد گرديد. بدین روش که 800 میکروگرم ( چهار عدد قرص 200 میکروگرم) بصورت خوراکی درهر سه ساعت( تا سه دوز) استفاده خواهد گردید. در صورت عدم دفع جنین، دوز فوق در روز دوم مجددا تکرار خواهد گردید.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: حسین ماری اریاد
Full name of responsible person - Persian: Hossein Mari-Oriad
Street address - English: No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
Street address - Persian: کهگیلویه و بویراحمد، یاسوج، خیابان شهید جلیل، پلاک 7916839319
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7916839319
Phone: +98 74 3333 7251
Fax:
Email: dr.samirakalami@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hossein Mari-Oriad
Full name of responsible person - Persian: حسین ماری اریاد
Street address - English: No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
Street address - Persian: کهگیلویه و بویراحمد، یاسوج، خیابان شهید جلیل، پلاک 7916839319
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7916839319
Phone: +98 74 3333 7251
Fax:
Email: dr.samirakalami@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: حسین ماری اریادHossein Mari-Oriad Full name of responsible person - Persian: Hossein Mari-Oriadحسین ماری اریاد Street address - English: No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad Street address - Persian: کهگیلویه و بویراحمد، یاسوج، خیابان شهید جلیل، پلاک 7916839319 City - English: Yasuj City - Persian: یاسوج Province: Kohgilouyeh-va-Boyrahmad Country: Iran (Islamic Republic of) Postal code: 7916839319 Phone: +98 74 3333 7251 Fax: Email: dr.samirakalami@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
Design
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 40 patients
Settings and conduct
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.
Participants/Inclusion and exclusion 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
Intervention groups
Group A: Stachys lavandulifolia extract will be administered in the form of tablets (200 mg every three hours, up to two doses) along with 400 micrograms (up to two 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.
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.
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N7
Registration date:2020-07-01, 1399/04/11
Registration timing:registered_while_recruiting
Last update:2021-04-02, 1400/01/13
Update count:2
Registration date
2020-07-01, 1399/04/11
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
Public title
Misoprostol compared with Stachys lavandulifolia with misoprostol on the rate of abortion in the first trimester
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.YUMS.REC.1398.147
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
O04.8
ICD-10 code description
(Induced) termination of pregnancy with other and unspecified complications
Primary outcomes
1
Description
Completed abortion
Timepoint
After intervention
Method of measurement
Symptom
2
Description
Incompleted abortion
Timepoint
After intervention
Method of measurement
Symptom
3
Description
Pain severity
Timepoint
After intervention
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Group A: Stachys lavandulifolia extract will be administered in the form of tablets (200 mg every three hours, up to two doses) along with 400 micrograms (up to two doses every three hours). If the fetus is not expelled, the above dose will be repeated on the second day.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Samira Kalami
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
یاسوج
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.samirakalami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari-Oriad
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.samirakalami@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Samira Kalami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.samirakalami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Samira Kalami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.samirakalami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Samira Kalami
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.samirakalami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD