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the effect of misoprostol with and without letrozole in successful Induction of medical abortion and its relation with BHCG titrage and cervical length

Protocol summary

Study aim
• Determining the effect of misoprostol alone in inducing successful medical abortion • Determining the effect of misoprostol with letrozole in inducing successful medical abortion • Determining the effect of misoprostol alone in inducing successful medical abortion and its relationship with BHCG titration levels • Determining the effect of misoprostol with letrozole in inducing successful medical abortion and its relationship with BHCG titration levels • Determining the effect of misoprostol alone in inducing successful medical abortion and its relationship with cervical length • Determining the effect of misoprostol with letrozole in inducing successful medical abortion and its relationship with cervical length • Comparison of the effect of misoprostol with and without letrozole in inducing successful medical abortion and its relationship with cervical length • Comparison of the effect of misoprostol with and without letrozole in inducing successful medical abortion and its relationship with BHCG titration levels
Design
The study will be performed by randomization with block and rand function of Excel software with parallel, two-way blind groups, phase 2-3 on 120 patients.
Settings and conduct
comparative effect of misoprostol with and without letrozole in pregnant mothers> 18 weeks and abortion candidate in Sayad Shirazi Hospital in Gorgan by double-blind randomization and clinical trial with blinding the researcher and patient from the drug.
Participants/Inclusion and exclusion criteria
• Pregnant women candidates for termination of pregnancy under 18 weeks of gestation • Missed abortions • Legal and medical abortions • Single pregnancy • Hemoglobin level> 10 g/ l
Intervention groups
group A (recipients of misoprostol with letrozole) and group B (recipients of misoprostol with placebo)
Main outcome variables
Successful abortion of the fetus;Cervical length ;BHCG titration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200702047985N1
Registration date: 2020-07-16, 1399/04/26
Registration timing: registered_while_recruiting

Last update: 2020-07-16, 1399/04/26
Update count: 0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Samaneh Mohammadreza khani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3220 3150
Email address
mrkhn1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-09, 1399/04/19
Expected recruitment end date
2021-03-09, 1399/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of misoprostol with and without letrozole in successful Induction of medical abortion and its relation with BHCG titrage and cervical length
Public title
the effect of misoprostol in successful Induction of medical abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women candidates for termination of pregnancy under 18 weeks of gestation Missed abortions Legal and medical abortions Single pregnancy Hemoglobin level> 10 g/ l There should be no history or evidence of adrenal pathology, malignancies, porphyria, thromboembolism, severe or recurrent liver disease, or gestational pruritus Being consent to participate in the study
Exclusion criteria:
Any sensitivity to misoprostol and letrozole Having an intrauterine device Having a history of more than 2 cesarean sections Any abnormalities in pre-treatment blood tests, including CBC, liver and abnormalities in kidney function tests, including blood urea, creatinine, albumin, globulin, liver enzymes, and electrolytes Specific medical conditions such as severe anemia, coagulation disorders, active liver disease, cardiovascular disease, glaucoma, and uncontrolled seizure disorders Having a history of thromboembolism, adrenal diseases, steroid-dependent cancer, porphyria, and disorders that require treatment with glucocorticoids, such as bronchial asthma
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after obtaining informed consent from patients, participants will be randomized using Block Randomization method into two groups, including group A (recipients of misoprostol with letrozole) and group B (recipients of misoprostol with placebo). In this way, all possible quadruple blocks (120 blocks) that include two groups are written, and each number is assigned to one of the blocks of the table and thus represents its particular state. Randomly, based on the table of random numbers obtained by the computer program, a block will be selected, then based on that, the samples will enter into the different groups of the study. This work will be continued until we reach a sufficient number of samples in each group (4 blocks will be selected by 42 times applying the permutation method.) For example, if block 1 will be selected in the first selection, this means that the first two samples should enter group A, and the third and fourth samples should enter group B. Likewise, the block will be selected again for the next 4 samples. Also during the randomization, matching between the two groups should be applied in terms of age, maternal parity, type of delivery, history of previous miscarriage, fetal anomaly and fetal death (Fetal Death) and the above cases should be included in both groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications will be given to patients in a similar form and package by a clinical caregiver, and the researcher will only evaluate patients and evaluate the consequences.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Science
Street address
Ethics Committee of the Vice Chancellor for Research and Technology, 3rd Floor, School of Dentistry, Golestan University of Medical Sciences, Shast Kola Road, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-06-27, 1399/04/07
Ethics committee reference number
IR.Goums.Rec.1399.076

Health conditions studied

1

Description of health condition studied
medical Abortion
ICD-10 code
O02.1
ICD-10 code description
Missed abortion

Primary outcomes

1

Description
Percentage of induction of successful fetal abortion with transvaginal ultrasound
Timepoint
group A members will receive up to 10 mg letrozole (2.5 mg letrax tablets, made by Abu Reihan Pharmaceuticals [Iran]) on days 1 to 3. Group B members will also receive placebo tablets, similar in appearance and taste to letrozole tablets , on days 1 to 3 .finally all patients will undergo transvaginal ultrasound on the fifth day after medical therapy
Method of measurement
Transvaginal ultrasound for successful abortion and BHCG check

Secondary outcomes

1

Description
Side Effects of Misoprostol
Timepoint
During the study, blood pressure, heart rate and patient temperature will be checked every four hours by the ward nurse and side effects including fever (body temperature more than 38 degrees of Celsius), sweating, hot flashes, arthralgia and fatigue, nausea, vomiting, bone pain, dizziness, muscle aches, diarrhea, abdominal pain, stomach pain, vaginal bleeding, sore throat, pain when urinating, difficulty in urinating, cough, rash, flu-like symptoms, difficulty in sleeping or in staying asleep, amount of bleeding, and the time of discarding of the residual tissue will be recorded by the resident and these data will be written in the patient's dossier.
Method of measurement
Measuring fever with a thermometer and measuring blood pressure with a cuff pressure gauge, clinical examinations and a history of the patient

Intervention groups

1

Description
Intervention group: Receptors of misoprostol and letrozole/). group A members will receive up to 10 mg letrozole (2.5 mg letrax tablets, made by Abu Reihan Pharmaceuticals [Iran]) on days 1 to 3. then on the morning of the third day of the study and will receive 800 micrograms of misoprostol (200 microgram misoglandin tablets, made by Samisaz Pharmaceuticals of Iran), including four 200 microgram tablets, vaginally
Category
Treatment - Drugs

2

Description
Control group: recipients of misoprostol and placebo/Group B members will also receive placebo tablets, similar in appearance and taste to letrozole tablets produced by the Isfahan School of Pharmacy, on days 1 to 3 .then on the morning of the third day of the study and will receive 800 micrograms of misoprostol (200 microgram misoglandin tablets, made by Samisaz Pharmaceuticals of Iran), including four 200 microgram tablets, vaginally
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sayad Shirazi Hospital in Gorgan
Full name of responsible person
Dr. Moghadase Jahanshahi
Street address
Women's Clinic and Obstetrics and Gynecology Department, 2nd floor, Shahid Sayad Shirazi Hospital, Sayad Shirazi Blvd., Bahonar Square, Gorgan, Iran
City
gorgan
Province
Golestan
Postal code
4915663158
Phone
+98 17 3226 1150
Email
infosayyad@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Bahonar
Street address
Ethics Committee of the Vice Chancellor for Research and Technology, 3rd Floor, School of Dentistry, Golestan University of Medical Sciences, Shast Kola Road, Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4915663158
Phone
+98 17 3245 1660
Email
tahghighat.g@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr Moghadase Jahanshahi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Women's Clinic and Obstetrics and Gynecology Department, 2nd floor, Shahid Sayad Shirazi Hospital, Sayad Shirazi Blvd., Bahonar Square, Gorgan, Iran
City
gorgan
Province
Golestan
Postal code
4915663158
Phone
+98 17 3226 1150
Email
Mogh.jahanshahi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Samaneh Mohammadreza khani
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 4, Sarkhajeh Street 7 َAve, Sarkhajeh Blvd, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3220 3150
Fax
Email
mrkhn1366@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Samaneh Mohammadreza khani
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 4, Sarkhajeh Street 7 َAve, Sarkhajeh Blvd, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4918936316
Phone
+98 17 3220 3150
Fax
Email
mrkhn1366@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
• Information obtained from patients will be confidential and only accessible by the investigators and after the study is completed, only part of it will cover the main implications.
When the data will become available and for how long
Data access period begins 3 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Any statistical analysis on the data is possible.
From where data/document is obtainable
Dr. Samaneh Mohammad Reza Khani, Email Address: mrkhn13662gmail.com phone number: 09129487710
What processes are involved for a request to access data/document
If the applicant states the purpose of receiving the data and submits a proposal file related to the subject of his / her present study in a copy to the project executor, the file will be received after two weeks.
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