Evaluation of the effect of Stachys lavandulifolia on the rate of abortion in the first trimester compared with misoprostol
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 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.
Evaluation of the effect of Stachys lavandulifolia on the rate of abortion in the first trimester compared with misoprostol
Public title
Stachys lavandulifolia on the rate of abortion in the first trimester compared with misoprostol
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 4 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
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 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.
Category
Treatment - Drugs
2
Description
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.
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
حسین ماری اریاد
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