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Combined effect of dexamethasone, hyoscine and misoprostol drugs during therapeutic or legal abortion in patients visiting Imam Khomeini Hospital in Tehran

Protocol summary

Study aim
Effect of the combined effect of dexamethasone and hyoscine with misoprostol during therapeutic or legal abortion in patients visiting Imam Khomeini Hospital in Tehran.
Design
The study is conducted at Imam Khomeini Hospital in Tehran. In this study, 75 women diagnosed with medical or legal abortion from the time of approval of the plan until reaching the desired sample size are included in the study.
Settings and conduct
Individuals are assigned to three study groups (A: misoprostol, B: misoprostol + dexamethasone, and C: misoprostol + hyoscine) using a random allocation table and block classification. Misoprostol is according to Figo protocol and is used vaginally. Dexamethasone and hyoscine are administered intramuscularly, and placebo intramuscular injection is performed for the misoprostol group alone.
Participants/Inclusion and exclusion criteria
Inclusion criteria: pregnant women aged 25-45 who have become pregnant spontaneously and the need for a therapeutic or legal abortion has been definitively diagnosed. Exclusion criteria: drug sensitivity, presence of intrauterine device (IUD), severe anemia, coagulation disorder or use of anticoagulants, active liver disease, cardiovascular disease, uncontrolled seizures, adrenal disease with high blood pressure, use Steroid drugs.
Intervention groups
The three pharmacological interventions are as follows: 1. The first group (A) receiving misoprostol 2. The second group (B) receiving misoprostol + dexamethasone 3. The third group (C) receiving misoprostol + hyoscine The non-blinded clinical trial (only the patients are not aware of the group allocation) includes 75 people who are randomly divided into 3 equal intervention groups of 25.
Main outcome variables
Examining and comparing the amount of pain, the amount of bleeding, the success of medical abortion and the time required to perform an abortion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180409039247N9
Registration date: 2024-01-04, 1402/10/14
Registration timing: prospective

Last update: 2024-01-04, 1402/10/14
Update count: 0
Registration date
2024-01-04, 1402/10/14
Registrant information
Name
Marjan Ghaemibidgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4858
Email address
m_ghaemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined effect of dexamethasone, hyoscine and misoprostol drugs during therapeutic or legal abortion in patients visiting Imam Khomeini Hospital in Tehran
Public title
Combined effect of dexamethasone, hyoscine and misoprostol drugs during therapeutic or legal abortion in patients visiting Imam Khomeini Hospital in Tehran
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant woman aged 25-45 who has become pregnant spontaneously and the necessity of performing a therapeutic or legal abortion has been definitively diagnosed. Patient's awareness and acceptance of two medical and surgical methods and complications resulting from each of them Intrauterine pregnancy with a gestational age of 14 weeks or less based on ultrasound or the date of the last menstrual period a reason to terminate the pregnancy (missed abortion, blighted ovum, therapeutic abortion)
Exclusion criteria:
Allergy to Drug IUD (intrauterine device) severe anemia coagulation disorder or use of anticoagulants uncontrolled seizures adrenal disease with high blood pressure cardiovascular disease active liver disease use Steroid drugs
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are assigned to three study groups (A: misoprostol, B: misoprostol + dexamethasone, and C: misoprostol + hyoscine) using a random allocation table and block classification.The randomization list will be administered using identical, sequentially numbered study drug containers, and these containers will be identically labeled by two investigators who will not be involved in the recruitment of study subjects. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 3 alleles of size 6
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
East Bagherkhan Street
City
Tehran
Province
Tehran
Postal code
14146
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.289

Health conditions studied

1

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

Primary outcomes

1

Description
Comparison of intervention in the amount of patient pain during abortion, comparison of intervention in the amount of patient bleeding during abortion, comparison of intervention in the time required for abortion
Timepoint
The amount of bleeding and the time required are measured at the end of the process.
Method of measurement
The amount of bleeding is measured based on the patient's pads and the time is measured based on hours and minutes.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Vaginal misoprostol 400 micro every 4 hours until abortion
Category
Treatment - Drugs

2

Description
Intervention group: Vaginal misoprostol 400 micrograms every 4 hours + dexamethasone 8 mg intravenous injection (with the first dose of misoprostol)
Category
Treatment - Drugs

3

Description
Intervention group: Vaginal misoprostol 400 micrograms every 4 hours + one dose of hyosin 20 mg intravenous injection (with the first dose of misoprostol)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Marjan Ghaemi
Street address
East Bagherkhan Street
City
Tehran
Province
Tehran
Postal code
14146
Phone
+98 912 196 7735
Email
marjan_ghaemi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
East Bagherkhan Street
City
Tehran
Province
Tehran
Postal code
14146
Phone
+98 21 6658 1616
Email
info@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
14146
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
14146
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
14146
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
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