Comparison of efficacy and side effects of two different routes of sublingual or buccal administration of misoprostol
Design
Phase 3 randomized clinical trial with a control group, single-blind, on 300 patients, randomized by block randomization method using Sealedenvelop.com website software.
Settings and conduct
The study will be conducted in Akbarabadi Hospital. 300patients with an indication of abortion are included in the study and randomly receive one of the two interventions of sublingual or buccal misoprostol. The success of the treatment is compared between the two groups. In this study, the outcome assessor and data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Women over 18 years of age with an indication of abortion in the first trimester who consent to participate in the study and do not have a previous history of cesarean section or sensitivity to misoprostol.
Intervention groups
Sublingual and buccal misoprostol recipients
Main outcome variables
Treatment failure, drug side effects, length of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230617058504N1
Registration date:2024-03-13, 1402/12/23
Registration timing:prospective
Last update:2024-03-13, 1402/12/23
Update count:0
Registration date
2024-03-13, 1402/12/23
Registrant information
Name
Sarah Ghorbanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 6034
Email address
ghorbanzadeh.iums@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of buccal and sublingual misoprostol administration in first trimester abortions: a clinical trial study
Public title
Sublingual and buccal misoprostol in the first trimester abortions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abortion indication in the first trimester (including legal abortion, missed abortion, incomplete induced abortion)
Signing informed consent
Exclusion criteria:
Allergy to misoprostol
Previous history of cesarean section
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using block randomization method with a block size of 4. The random sequence is generated by Sealedenvelope.com website software and is made available by an independent person outside the study. After the people enter the study, it is provided to the researcher one by one.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome evaluator collects information related to the outcome without knowing the type of intervention; without asking the volunteers. The information is provided to the analyst in the form of two intervention codes A and B, so he/she is unaware of the intervention type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee on Ethics in Biomedical Research, Faculty of Medicine, Iran University of Medical Sciences
Street address
Next to Milad tower. Hemmat exp.way
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.IUMS.FMD.REC.1402.447
Health conditions studied
1
Description of health condition studied
Medical abortion of the first trimester
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Percentage of treatment failure
Timepoint
24 hours post-intervention
Method of measurement
Evaluation of the complete excretion of the product of pregnancy through clinical history and examination and in case of uncertainty, through ultrasound
Secondary outcomes
1
Description
Misoprostol side effects
Timepoint
Immediately after , 6, 24 and 48 hours post-intervention
Method of measurement
Clinical history and examination
2
Description
Lenght of hospitalization
Timepoint
Time of discharge
Method of measurement
Based on the information of the medical records
Intervention groups
1
Description
Intervention group 1: Recipient of sublingual misoprostol : In this group of patients, 4 tablets of misoprostol 200 are taken sublingually every 3 hours up to three times a day.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intervention group: Recipient of buccal misoprostol : In this group of patients, 4 tablets of misoprostol 200 are taken buccally every 3 hours up to three times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Mojgan Mokhtari
Street address
Bagh Ferdous station, Molavi st.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
mokhtari.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mojgan Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bagh Ferdous Station, Molavi. St.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 6655 2972
Email
mokhtari.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojgan Mokhtari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bagh Ferdous Station, Molavi. St.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 6655 2972
Email
mokhtari.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sarah Ghorbanzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bagh Ferdous Station, Molavi. St.
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
Email
ghorbanzadeh.s@doctorid.ir
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