Comparison of the effect of intrauterine misoprostol administration with sublingual in second trimester abortions induction
Design
This is a clinical trial study on 86 patients. Patients will be randomly divided into two groups 1 and 2 in parallel based on the random score assigned by rendomizer software. The researcher and analyst will be blinded in this study.
Settings and conduct
This study is performed in Tabriz University of Medical Sciences. In this study, all pregnant women with a gestational age of 12 to 22 weeks who are candidates for legal abortion included in the study. This study is performed as a randomized Double-blind clinical trial .Data collection is completed by the questioner which is done through a checklist.The sample size was 86 people. are randomly divided in two equal groups 1 and 2.
Participants/Inclusion and exclusion criteria
Women with the indication of termination of pregnancy will be included in the study in the second trimester and will be excluded from the study if they have coagulation problems and a history of cesarean section.
Intervention groups
The first group includes intrauterine administration of misoprostol. A catheter under direct vision and by using the vaginal speculum will be entered the uterine space through the endocervix and 500 micrograms of misoprostol, 2 tablets of 200 micrograms, a tablet of 100 micrograms will be Dissolved in saline under sterile conditions at a rate of 20 drops per minute equivalent to 1 micrograms will be constantly infused and this infusion will be continued until the fetus is expelled or the catheter is expelled. In the second group, misoprostol pills will be prescribed sublingually based on gestational age according to the FIGO protocol
Main outcome variables
The interval between the onset of abortion induction and the expulsion of pregnancy products is considered to be the main consequence.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130626013777N3
Registration date:2022-07-08, 1401/04/17
Registration timing:registered_while_recruiting
Last update:2022-07-08, 1401/04/17
Update count:0
Registration date
2022-07-08, 1401/04/17
Registrant information
Name
Shamsi Abbasalizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
abbasalizadehs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-01, 1401/04/10
Expected recruitment end date
2023-07-01, 1402/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intrauterine misoprostol administration with sublingual in second trimester abortions induction
Public title
Comparison of the effect of intrauterine misoprostol administration with sublingual in second trimester abortions induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 16 years
Gestational age 14 to 22 weeks based on first trimester ultrasound
Consent to participate in the study
Having an indication for termination of pregnancy
Exclusion criteria:
Coagulation disorders or taking anticoagulant
Possibility of ectopic pregnancy
Probability of molar pregnancy
Women with an IUD
Women with a history of one or more cesarean sections or a history of uterine incision or myoctomy
Pregnancy of placenta peria
Parity 5 times or more
Age
From 16 years old
Gender
Female
Phase
2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who meet the inclusion criteria are divided into two intervention groups using simple randomization method.The randomization method used in this study is the use of a table of random numbers.Random number table is a set of numbers that is generated without a specific pattern or order and they generated randomly and they are formed in a table.In first the direction of reading the numbers was specified.To read the numbers, random numbers are read from the left side of the table, then even numbers extracted from the table are allocated to intervention group 1 and odd numbers extracted from the table are allocated to intervention group 2.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient numbers will be randomly distributed in two groups, in a ratio of 1: 1 and will be kept inside a sealed envelope.The assistant of the researcher who is not in contact with the patients and will only be responsible for keeping the envelopes will announce how to induce the abortion after the call of the researcher based on the number assigned to the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
تبریز
Province
East Azarbaijan
Postal code
5166616471
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.TBZMED.REC.1401.160
Health conditions studied
1
Description of health condition studied
Therapeutic Abortion
ICD-10 code
O04
ICD-10 code description
Therapeutic/Medical Abortion (termination of pregnancy)
Primary outcomes
1
Description
The time interval between induction of abortion and excretion of pregnancy products
Timepoint
From the beginning of the intervention until the complete rejection of the fetus
Method of measurement
Clinical examination and ultrasound
Secondary outcomes
1
Description
Fever
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Thermometer
2
Description
Nausea
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
3
Description
Vomiting
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
4
Description
Chills
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
5
Description
chills
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
6
Description
Headache
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
7
Description
Skin rash
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
8
Description
Dizziness
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
9
Description
Dfficulty breathing
Timepoint
Every 4 hours from the beginning of the intervention until the complete abortion of the fetus
Method of measurement
Clinical examination
Intervention groups
1
Description
The first group includes intrauterine administration of misoprostol. A catheter under direct vision and under sterile conditions using chlorhexidine or betadine by using the vaginal speculum will be entered the uterine space through the endocervix and its balloon will be dilated with 30 cc of sterile saline or sterile distilled water. The infusion set will be connected to a Foley catheter and a 50 cc solution containing 500 micrograms of misoprostol (manufactured by Abu Reihan-Iran Pharmaceutical Company), 2 tablets of 200 micrograms, a tablet of 100 micrograms will be Dissolved in saline under sterile conditions at a rate of 20 drops per minute equivalent to 1 micrograms will be constantly infused and this infusion will be continued until the fetus is expelled or the catheter is expelled.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second group, misoprostol 400 microgram tablets (manufactured by Abu Reihan-Iran Pharmaceutical Company) are administered sublingually every 4 hours with control of vital signs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Shamsi Abbasalizadeh
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
alzahrahosp@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Vice chancellor for Research,Tabriz University Of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Abbasalizadeh
Position
Professor Of Obstetricians and Gynecologists
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
shamciabbasalizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Abbasalizadeh
Position
Gynecology and Obstetrics
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
shamciabbasalizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shamsi Abbasalizadeh
Position
Professor Of Obstetricians and Gynecologists
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1553 9161
Email
shamciabbasalizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available