Comparison of the efficacy of vaginal isoniazid with sublingual misoprostol and sublingual misoprostol alone in inducing abortion during the first three months of pregnancy
Design
A randomized controlled clinical trial with parallel groups, without blinding
Settings and conduct
In the first group vaginal isoniazid (mg 1500) is placed and 12 hours later sub-lingual misoprostol (800 μg) administered. In the absence of vaginal bleeding or pain, repeat up to 3 doses every 3 hours. In second Group, they receive only the second vaginal misoprostol. After the first dose of misoprostol, abortion was considered successful within 24 hours after ablation, and vaginal ultrasound will be performed to check for residuals. In the absence of residuals, "complete abortion" is reported. In cases of residues below 3 cm, "successful disposal" and "incomplete abortion" are reported. Misoprostol 800μg should be used again every three hours for up to three doses if residuals above 3 cm, failure to excretion, or visualization of pregnancy sacs. At the end of the second 24 hours, vaginal ultrasound was performed to examine the remains. Patients were divided into one of the following groups based on the interval between the onset of misoprostol and the expulsion of the tissue that is considered as successful treatment:
Abortion under 6 hours
Abortion under 12 hours
Abortion under 24 hours
Abortion under 48 hours
Participants/Inclusion and exclusion criteria
All Grade One pregnant women with no vaginal bleeding and whole package with gestational age less than or equal to 91 days based on LMP and ultrasound (blighted ovum, missed abortion, legal abortion) and are candidates for termination of pregnancy or have a forensic abortion permit are enrolled in the study.
Intervention groups
The intervention group received isoniazid plus misoprostol
The control group received only misoprostol.
Main outcome variables
abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190819044561N1
Registration date:2020-02-19, 1398/11/30
Registration timing:retrospective
Last update:2020-02-19, 1398/11/30
Update count:1
Registration date
2020-02-19, 1398/11/30
Registrant information
Name
Mahshid Shirvani Ghadikolaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7762 6006
Email address
shirvani.mahshid777@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-09-21, 1398/06/30
Scientific title
A comparison between the effect of Isoniazid together with Misoprostol and Misoprostol on abortion in the first three months of pregnancy.
Public title
A comparison between the effect of Isoniazid together with Misoprostol and Misoprostol on abortion in the first three months of pregnancy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than 13 weeks
Primigravida
Without vaginal bleeding
Closed cervical os
Candidate for pregnancy termination
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran. Tehran . Hemmat Highway . Next to Milad Tower
City
تهران
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.IUMS.FMD.REC1369.9511290012
Health conditions studied
1
Description of health condition studied
Abortion
ICD-10 code
0o3
ICD-10 code description
Miscarriage
Primary outcomes
1
Description
Abortion Time
Timepoint
During the intervention
Method of measurement
hour
Secondary outcomes
1
Description
Vomit
Timepoint
During the intervention
Method of measurement
See
2
Description
Diarrhea
Timepoint
During the intervention
Method of measurement
see
3
Description
Fever
Timepoint
During the intervention
Method of measurement
Celsius
Intervention groups
1
Description
Intervention group: First, 1500 mg of vaginal isoniazid is administered, and then 12 hours later, 800 micrograms of sub-lingual misoprostol.Repeat every three hours to three doses.
Category
Treatment - Drugs
2
Description
Control group: Only 800 μg of sublingual misoprostol was given every 3 hours up to 3 doses.