Objective : The purpose of this study was to compare the efficacy of two different misoprostol diets in second trimester pregnancy termination . Methods : 60 consenting women who were on 14 to 28 weeks of gestational age with indications of pregnancy termination due to missed abortion ,fetal abnormality ,fetal death and PROM per ultrosound twice were randomly allocated in two equal groups of 30 persons to receive either vaginal or oral misoprostol .Dosage diet was 400 µg as an initial ones which was followed by another 400 µg up to 3 dosage (1200 µg) if it was needed . The due date of termination was 48 hours after the last dosage.Otherwise,the oxytocin or surgery methods was used. It was recommended to reffer two weeks later for ultrasound to investigate of pregnancy residual and determine weather D&C was needed or not.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706061106N1
Registration date:2008-09-27, 1387/07/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-09-27, 1387/07/06
Registrant information
Name
Zohreh Azarbad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2999
Email address
azarbad_zo@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
KASHAN UNIVERSITY OF MEDICAL SCIENCES
Expected recruitment start date
2006-08-22, 1385/05/31
Expected recruitment end date
2007-03-23, 1386/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the oral and vaginal Misoprostol effects on Pregnancy Termination in Second
Public title
Comparison between the oral and vaginal Misoprostol effects on Pregnancy Termination in Second
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Pregnant women in( 14- 28 week) were candidate in termination because of missed abortion ,fetal abnormality ,fetal death and premature rupture of membrane.
Exclusion criteria :Uncontrolled seizure, asthma,glucohema,hypertension ,COPD,mitral stenosis,inflammatory intestinal disease,history of allergy to PG E1.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
KASHAN UNIVERSITY OF MEDICAL SCIENCES
Street address
KASHAN UNIVERSITY OF MEDICAL SCIENCES,DEPUTY OF RESEARCH
City
KASHAN
Postal code
87155-111
Approval date
empty
Ethics committee reference number
29-5-1-7409
Health conditions studied
1
Description of health condition studied
pregnancy termination in Second Trimester
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PREGNANCY TERMINATION
Timepoint
begining of study -every 6 hours up to 48 hours
Method of measurement
dilatation of cervix-contraction and hemorrhage
Secondary outcomes
1
Description
Gastrointestinal disorders
Timepoint
every one hours until the last dosage
Method of measurement
Clinical examination
2
Description
fever
Timepoint
every one hours until the last dosage
Method of measurement
vital sign
Intervention groups
1
Description
Intervention:vaginal misoprostol
Category
empty
2
Description
Control: oral misoprostol
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
shabihkhani hospital
Full name of responsible person
dr mohsen dibaji
Street address
kashan - beheshti hospital
City
kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
kashan university of medical sciences
Full name of responsible person
dr golam ali hamidi
Street address
kashan-kashan university of medical sciences- deputy of research
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kashan 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
kashan university of medical sciences
Full name of responsible person
Mitra Behrashi
Position
assisstant professor
Other areas of specialty/work
Street address
kashan- ShabihKhani hospital
City
kashan
Postal code
871471555
Phone
+98 36 1446 0180
Fax
+98 36 1444 1170
Email
dr-behrashi2006@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
kashan university of medical sciences
Full name of responsible person
dr mitra behrashi
Position
asistant professor
Other areas of specialty/work
Street address
kashan- shabihkani hospital
City
kashan
Postal code
871471555
Phone
+98 36 1446 0180
Fax
+98 36 1444 1170
Email
Dr_behrashi2006@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Zohreh Azarbad
Position
manager of research affairs
Other areas of specialty/work
Street address
kashan- kashan university of medical sciences-deputy of research
City
Kashan
Postal code
87155/111
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
azarbad_zo@kaums.ac.ir
Web page address
kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)