Comparison of the effectiveness of medical versus surgical strategy for first trimester therapeutic abortion
Design
Non-randomized controlled trial (quasi experimental analysis), with control group, parallel group, without blinding, on 140 women (70 for each group)
Settings and conduct
This study are performing with the participation and supervision of a gynecologist on patients referred to Akbarabadi Mothers Support Center, Hazrat Rasoul Akram Hospital and Firoozgar Hospital in Tehran during early six months of persian new year.
Participants/Inclusion and exclusion criteria
Women seeking first trimester therapeutic abortion at the age 18 to 45 without underlying diseases particularly the cancers
Intervention groups
The intervention group includes women who use the drug method (misoprostol) to perform the treatment process of abortion, The control group includes women who use surgery (curettage) to perform abortion treatment.
Main outcome variables
Success rate of abortion treatment in the first trimester of pregnancy, possible complications of each intervention including severe bleeding, infection, uterine injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210916052504N1
Registration date:2021-11-20, 1400/08/29
Registration timing:prospective
Last update:2021-11-20, 1400/08/29
Update count:0
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
Saeed Husseini Barghazan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8867 1615
Email address
hoseyni.sa@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of medical versus surgical abortion for first trimester therapeutic in Iran; A quasi experimental analysis
Public title
The efficacy of medical versus surgical abortion for first trimester therapeutic in Iran; A quasi experimental analysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women seeking first trimester therapeutic abortion
Research Ethics Committees of Iran University of Medical Sciences
Street address
School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2020-04-06, 1399/01/18
Ethics committee reference number
IR.IUMS.REC.1399.068
Health conditions studied
1
Description of health condition studied
Missed abortion
ICD-10 code
O02.1
ICD-10 code description
Missed abortion
2
Description of health condition studied
Complications following (induced) termination of pregnancy
ICD-10 code
O04
ICD-10 code description
Complications following (induced) termination of pregnancy
3
Description of health condition studied
(Induced) termination of pregnancy with other and unspecified complications
ICD-10 code
O04.8
ICD-10 code description
(Induced) termination of pregnancy with other and unspecified complications
Primary outcomes
1
Description
Success rate of abortion treatment in the first trimester of pregnancy termonation
Timepoint
The patient's clinical condition based on the physician's opinion 14 days after receiving the first medication or surgery
Method of measurement
Questionnaire, test, imaging and doctor's opinion
Secondary outcomes
1
Description
Possible side effects of treatment include severe bleeding, need to repeat the abortion process, infection or damage to the uterus
Timepoint
Clinical status of the patient 14 days after receiving the first treatment intervention
Method of measurement
Questionnaire, test, imaging and doctor's opinion
Intervention groups
1
Description
Medical intervention with three doses of misoprostol 400 mg (with trade name Cytotec) sublingual and vaginal 6 hours apart
Category
Treatment - Drugs
2
Description
Dilation and curettage (D & C), the dilation of the cervix and surgical removal of part of the lining of the uterus and/or contents of the uterus by scraping and scooping along with 200 mg of misoprostol at the time of surgery and 6 hours after that
School of Health Management and Information Sciences, No. 6, Rashid Yasemi St. Vali –e Asr Ave, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8878 2919
Fax
Email
Hoseyni.sa@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
This research is part of the dissertation of the PhD course in Health Economics, which is conducted at Iran University of Medical Sciences. Any sharing is done by this university.
When the data will become available and for how long
Second six month of 1401, central library of iran university of medical sciences
To whom data/document is available
In order to facilitate decisions at the level of the health system and policy makers, by physicians or patient preferences, as well as the researchers
Under which criteria data/document could be used
In order to facilitate decisions at the level of the health system and policy makers, by physicians or patient preferences
From where data/document is obtainable
Website or Central Library of Iran University of Medical Sciences
What processes are involved for a request to access data/document
Website or Central Library of Iran University of Medical Sciences