The purpose of this study is to investigate the effect of misoprostol in abortion therapy.This analysis design is a controlled clinical trial.
Inclusion criteria: Pregnant women undergoing therapeutic abortion; aged 15 to 35 years; consent on clinical trials conducted in this study.
Exclusion criteria: previous cesarean section; prior uterine myomectomy; allergies and contraindications to the use of prostaglandins; vaginal bleeding before treatment; rupture of Mambranha or vaginitis before treatment; dissatisfaction upon entering the study.The sample is 70 pregnant women undergoing therapeutic abortion during1391-1392 years to treat with misoprostol.After obtaining informed consent and collecting data (age, times of pregnancy, gestational age, indication for therapeutic abortion, a dose-and time-effects and complications of any procedure)in questionnaire, vaginal and oral misoprostol with gμ 400 Stat, then gμ 200 every 6 hours Up to 48 hourswill be treat. Positive therapeutic results is cervical opening and exitting pregnancy product completely that is equal to passage of #6 bogies.If the cervix is not opening or residual D & C is used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013090414563N1
Registration date:2014-01-27, 1392/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-27, 1392/11/07
Registrant information
Name
Mozhgan Arman
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1442 1651
Email address
m.arman@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation efficacy of vaginal and oral misoprostol on abortion therapy in pregnant women15-35 years old
Public title
efficacy of misoprostol on abortion therapy
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria : pregnant women undergoing therapeutic abortion; aged 15 to 35 years; satisfaction of the trial conducted in this study.
The exclusion criteria : previous cesarean section; previous uterine Myomectomy;allergies and contraindications for the use of prostaglandins;vaginal bleeding before treatment; or rupture of Mambrane or vaginitis before treatment ;dissatisfaction upon entering the study.
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, SHastkola Road, Hyrkan boulevard
City
Gorgan
Postal code
4934174515
Approval date
2013-06-19, 1392/03/29
Ethics committee reference number
77392032904
Health conditions studied
1
Description of health condition studied
abortion therapy
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
abortion therapy
Timepoint
per 6 hours to 48 hours
Method of measurement
Bougie#(6) passed through the cervix
Secondary outcomes
1
Description
Interval between administration of the drug to induce abortion..
Timepoint
Interval between Putting tablets in the vagina to induce abortion
Method of measurement
Per hour
2
Description
Adverse Drug Reactions
Timepoint
when The problem occurred
Method of measurement
researcher Find
3
Description
indication of abortion
Timepoint
when hospitalization
Method of measurement
The researcher identified
Intervention groups
1
Description
Misoprostol 200 micrograms - the 400 and the 200 every 6 hours for 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sayyad SHirazi Hospital
Full name of responsible person
Mozhgan Arman
Street address
Sayad SHirazi Hospital, Boulevard Sayyad SHirazi
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mozhgan Arman
Street address
Golestan University of Medical Sciences,SHastkola Road, Hyrkan boulevard
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Mozhgan Arman
Position
resident at Obstetrics & Gynecology
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, SHastkola Road, Hyrkan boulevard
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1651
Fax
Email
m.arman@goums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mozhgan Arman
Position
resident at Obstetrics & Gynecology
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, SHastkola Road, Hyrkan boulevard
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1651
Fax
Email
m.arman@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mozhgan Arman
Position
resident at Obstetrics & Gynecology
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, SHastkola Road, Hyrkan boulevard
City
Gorgan
Postal code
4934174515
Phone
+98 17 1442 1651
Fax
Email
m.arman@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)