Randomized clinical trial Comparison of therapeutic effects and side effects of misoprostol moistened with normal saline and acetic acid in induction of therapeutic abortion in the second trimester
Objective: comparison of therapeutic effects and side effects of misoprostol moistened with normal saline and acetic acid in induction of therapeutic abortion in the second trimester.
Design: randomized, single blind, placebo-controlled, single centre, phase II trial.
Setting and conduct: Patients are randomly classified to get vaginal administration of either acetic acid or normal saline moistened misoprostol tablets with a dose schedule of 400 microgram initially and then 200 microgram every 6 hours up to maximum 8 doses over 48 hours.
Inclusion criteria: healthy pregnant women in their second trimester of pregnancy (14-20 weeks) with closed cervix that are candidate for therapeutic abortion and agree to participate in this clinical trial.
Exclusion criteria: history of more than 2 cesarean section; history of cesarean section with uterine classic or T-shape incision; previous myomectomy; allergy to prostaglandins; severe vaginal bleeding before treatment; anemia Hb less than 7 g/dl ); coagulopathy; significant medical disorder(example, active liver disease, cardiovascular disease, renal failure, chronic adrenal failure, disorders requiring corticosteroid therapy); rupture of membrane and vaginitis. Intervention: Misoprostol prescription moistened by either acetic acid or normal saline.
Primary outcome measure is complete abortion rate at 24 and 48 hours.
Secondary outcome measures are induction abortion interval, failure rate and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120315634N1
Registration date:2014-05-03, 1393/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Tayebeh Jahed Bozorgan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
tayebe.jahed@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-01-27, 1392/11/07
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized clinical trial Comparison of therapeutic effects and side effects of misoprostol moistened with normal saline and acetic acid in induction of therapeutic abortion in the second trimester
Public title
The effect of misoprostol on the therapeutic abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: healthy pregnant women in their second trimester of pregnancy (14-20 weeks) with closed cervix who are candidate for therapeutic abortion and agree to participate in this clinical trial.
Exclusion criteria: history of more than 2 cesarean section; history of cesarean section with uterine classic or T-shape incision; previous myomectomy; allergy to prostaglandins; severe vaginal bleeding before treatment; anemia Hb less than 7 g/dl ); coagulopathy; significant medical disorder(example, active liver disease, cardiovascular disease, renal failure, chronic adrenal failure, disorders requiring corticosteroid therapy); rupture of membrane and vaginitis.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
91
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Shahid Beheshti University of Medical Sciences, Tehran, Iran
medical management of second trimester induced abortion
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Complete abortion rate at 24 and 48 hours
Timepoint
every 6 hours
Method of measurement
Questioneaire
Secondary outcomes
1
Description
failure rate
Timepoint
No abortions occurred in 48 hours
Method of measurement
sonography
2
Description
Side effects of drug
Timepoint
Every 6 hours
Method of measurement
Questionnaire
3
Description
Induction abortion interval from insertion of first dose of misoprostol
Timepoint
Every 6 hours
Method of measurement
hour
Intervention groups
1
Description
In intervention group misoprostol tablets is wetted with 3cc acetic acid 5% and then is inserted misoprostol 400 microgram vaginally followed by 200 microgram every 6 hours for maximum 48 hours.
Category
Treatment - Drugs
2
Description
In controlled group misoprostol is wetted with 3cc normal saline and then is inserted misoprostol 400 microgram vaginally followed by 200 microgram every 6 hours for maximum 48 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Nayereh Rahmati
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
'' Sahid Beheshti University of Medical Sciences, Yaman Street, Shahid Aarabi Avenue, Shahid Chamran Highway
City
Tehran
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, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mahdieh Hospital
Full name of responsible person
Nayereh Rahmati
Position
Resident ,Obstetric & Gynecology
Other areas of specialty/work
Street address
" Fadaeian Street, shoush Square " " Tehran "
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
n136054@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tayebeh Jahed Bozorgan
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 5506 6263
Fax
Email
tayebeh.jahed@yahoo.com; tayebe.jahed@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mahdieh Hospital
Full name of responsible person
Nayereh Rahmati
Position
رزیدنت زنان و مامایی
Other areas of specialty/work
Street address
" Fadaeian Street, shoush Square " " Tehran "
City
Tehran
Postal code
1858117311
Phone
+98 21 5506 6263
Fax
Email
n136054@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)