This study was aimed to compare the therapeutic results of two different regimen of vaginal Misoprostol (every 6 hours vs 12 hours) on the second trimester pregnancy termination. This randomized controlled trial was carried out at Kosar Hospital affiliated to Qazvin University of Medical Sciences and Health Services (Iran) in 2007. 140 pregnant women between 14-28 weeks of gestational age undergoing termination of pregnancy because of fetal anomaly, IUFD, PROM, severe oligohydramnious, or maternal diseases were randomly assigned into two equal groups. The first group received 400µg vaginal Misoprostol every 6 hours and the second group received the same dose of Misoprostol every 12 hours. Primary outcome was duration of induction time after administration of vaginal Misoprostol.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810193025N1
Registration date:2010-03-06, 1388/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-06, 1388/12/15
Registrant information
Name
Farideh Movahed
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 0307
Email address
fmovahed@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Qazvin University of Medical Sciences and Health Services, Iran
Expected recruitment start date
2007-03-22, 1386/01/02
Expected recruitment end date
2008-01-20, 1386/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of misoprostol administration in second trimester pregnancy termination
Public title
Comparison of misoprostol administration in second trimester pregnancy termination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women between 14 -28 weeks of gestation undergoing termination of pregnancy because of fetal anomalies, IUFD, PROM, severe Oligohydraminious, maternal diseases.
Exclusion criteria: uncontrolled heart diseases, acute asthmatic attack, glaucoma, history of cesarean section more than two times or classic cesarean section, previous incision on uterus, parity>6
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Vice-chancellor for Research, Qazvin University of Medical Sciences and Health Services, Iran
Street address
Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Approval date
2008-09-04, 1387/06/14
Ethics committee reference number
28/20/1128
Health conditions studied
1
Description of health condition studied
Medical abortion
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Interval between administeration of drug and expulsion of fetus
Timepoint
24 hours, 48 hours after intervention
Method of measurement
Duration, in hours
Secondary outcomes
1
Description
Total dose of misoprostol administeration in termination of pregnancy
Timepoint
every 6 hours in teh first group, every 12 hours in the second group
Method of measurement
Total dose administered, in microgram
Intervention groups
1
Description
Misoprostol, 400 mg, vaginal, every 6 hours, within 48 hours
Category
Treatment - Drugs
2
Description
Misoprostol, 400 mg, vaginal, every 12 hours, within 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital, Qazvin
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Qazvin University of Medical Sciences and Health Services, Iran
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
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, Qazvin University of Medical Sciences and Health Services, Iran
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
Vice-chancellor for Research, Qazvin University of Medical Sciences and Health Services, Iran
Full name of responsible person
Dr Farideh Movahed
Position
Assitant Professor, Obstetrican & Gynecologist
Other areas of specialty/work
Street address
Kosar hospital, Qazvin
City
Qazvin
Postal code
00982812222452
Phone
+98 28 1222 2452
Fax
Email
fmovahed@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice-chancellor for Research, Qazvin University of Medical Sciences and Health Services, Iran
Full name of responsible person
Dr Farideh Movahed
Position
Assitant Professor, Obstetrican & Gynecologist
Other areas of specialty/work
Street address
Qazvin-kosar hospital
City
Qazvin
Postal code
Phone
+98 28 1224 2452
Fax
Email
fmovahed@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)