Background:
To identify an effective misoprostol for the termination of 12-20 week of pregnancy, we compared sublingual and administration of multiple doses of misoprostol in a randomized, placebo-controlled
methods: 480 pregnant women requesting medical abortion at 12–20week into two treatment groups: 400 mg of misoprostol administered either sublingually or vaginally every 6 h, followed by sublingual administration of 400 mg misoprostol every 6. Successful abortion within 48 h was also considered as an outcome along with the inductionto-abortion-interval, side effects and women’s satisfactionon these treatments.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2013040912958N1
Registration date:2013-06-17, 1392/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Yassaman Aghajani
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
y-aghajani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-01, 1391/01/13
Expected recruitment end date
2013-04-01, 1392/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vaginal and sub-lingual misoprestol for induction of therapeutic abortion at 12- 20 weeks gestational age 2012-13
Public title
Misoprostol in therapeutic abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
All pregnant women with gestational age between 12 and 20 weeks who have medical indications for pregnancy termination 20-40 years old including fetal indications like structural or chromosomal fetal abnormalities, PROM, intrauterine fetal death or maternal indication such as pregnant women with hemoglobin less than 10 mg.
Exclusion Criteria:
pregnant women with any type of allergic reaction to misoprestol,
pregnant women high risk for rupture of uterine,
history of classic uterine incision or T-shaped incision,
women with a history of extensive surgery on the fundus of the uterus, pregnant women with IUD,
women with certain medical conditions such as severe anemia, clotting disorders or taking anticoagulant medication, active liver disease, glaucoma, uncontrolled seizure disorders, adrenal disease or disorder that requires treatment with glucocorticoids such as tracheobronchial asthma,
Smoking more than 20 cigarettes per day,
gynecologic abnormalities confirmed by ultrasound, mitral stenosis,
sickle cell anemia,
diastolic blood pressure more than 90 mm Hg, systolic pressure less than 90 mmHg,
history of thromboembolism and liver disease, hemolytic disorders and a history of two cesareans.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
480
Randomization (investigator's opinion)
Randomized
Randomization description
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, Faculty of Medicine
Street address
Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
-
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
91/د/176/130
Health conditions studied
1
Description of health condition studied
Therapeutic abortion
ICD-10 code
O04
ICD-10 code description
Therapeutic Abortion
Primary outcomes
1
Description
complete evacuation of products of conception
Timepoint
24-48 h
Method of measurement
Questinaire
Secondary outcomes
1
Description
pulse rate
Timepoint
24 and 48 hr
Method of measurement
examination
2
Description
Blood pressure
Timepoint
24 and 48 hr
Method of measurement
examination
3
Description
uterine contraction
Timepoint
24 and 48 hr
Method of measurement
examination
4
Description
mean induction to delivery time
Timepoint
24 and 48 hr
Method of measurement
Questionaire
5
Description
occurrence of side effects
Timepoint
24 and 48 hr
Method of measurement
Questionaire
Intervention groups
1
Description
In group A, patients received 400 mg of sub-lingual misoprestol every 6 hours to induce abortion and administration was discontinued in cases of severe contraction.
Category
Treatment - Drugs
2
Description
Group B, received 400 mg of vaginal tablet of misoprestol, placing in the vagina every 6 hours and treatment carried on until delivery of fetus or induction of severe contractures.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Ali Shariati hospital
Full name of responsible person
Nazila Mesbah
Street address
Dr.Ali Shariati Hospital, North Karegar St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhoundzade
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nazila Mesbah
Position
Resident of gynecology
Other areas of specialty/work
Street address
Dr.Ali Shariati Hospital, North Karegar St.
City
Tehran
Postal code
-
Phone
+98 21 8490 2414
Fax
-
Email
nazila.mesbah@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazila Mesbah
Position
Resident of gyencology
Other areas of specialty/work
Street address
Dr.Ali Shariati, North Karegar St.
City
Tehran
Postal code
-
Phone
+98 21 8490 2414
Fax
-
Email
nazila.mesbah@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazila Mesbah
Position
Resident of gynecology
Other areas of specialty/work
Street address
Dr.Ali Shariati, North Karegar St.
City
Tehran
Postal code
-
Phone
+98 21 8490 2414
Fax
-
Email
nazila.mesbah@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)