Comparison of The effect between two dose (800 µg/day & 400 µg/6) of vaginal misoprostol in the termination of first-trimester pregnancy: a double-blinded randomized trial
Background and aim: a higher dose of misoprostol may increase its efficacy on the termination of pregnancy, we compared the impact of 400 µg every 6 hours daily with 800 µg daily of vaginal misoprostol for termination of early pregnancy.
Methods and materials: in this randomized clinical trial 90 pregnant women with gestational age less than 96 days will be randomized to receive vaginal misoprostol either the 400 µg every 6 hours (group A) or 800 µg once a day (group B) for three days, then, success of abortion and complication of these methods were compared with each others. The criteria for enrollment are singleton pregnancy, indication for pregnancy termination due to either fetal or maternal causes and gestational age lower than 96 days and no previous misoprostol consuming.The exclusion criteria are any sign or symptom of threatened or spontaneous abortion before therapy such as bleeding, any degree of dilatation in cervix or uterine regular contractions before drug administration.
General information
Acronym
misoprostol in pregnancy
IRCT registration information
IRCT registration number:IRCT2017040633255N1
Registration date:2017-06-25, 1396/04/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-25, 1396/04/04
Registrant information
Name
Donya Khosravi
Name of organization / entity
Imam Hossein Hospital-ShahidBeheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 3634
Email address
donyakhosravi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-03-29, 1394/01/09
Expected recruitment end date
2016-01-29, 1394/11/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The effect between two dose (800 µg/day & 400 µg/6) of vaginal misoprostol in the termination of first-trimester pregnancy: a double-blinded randomized trial
Public title
Comparison of The effect between two dose (800 µg/day & 400 µg/6) of vaginal misoprostol in the termination of first-trimester pregnancy: a double-blinded randomized trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: singleton pregnancy; indication for pregnancy termination due to either fetal or maternal causes and gestational age lower than 96 days; no previous misoprostol consuming.
exclusion criteria: any sign or symptom of threatened; spontaneous abortion before therapy such as bleeding; any degree of dilatation in cervix or uterine regular contractions before drug administration.
Age
From 12 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
NA
Secondary trial Id
NA
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Shahid Beheshti University of Medical Sciences
Street address
Chamran highway Tabnak st near Taleghani Hospital
City
Tehran
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
sbmu.rec.1393.553
Health conditions studied
1
Description of health condition studied
need to medical abortion due to maternal indications or missed abortion and blighted ovum
ICD-10 code
O04.1
ICD-10 code description
Medical abortion : incomplete, complicated by delayed or excessive haemorrhage
Primary outcomes
1
Description
Complete abortion without needing to a surgery
Timepoint
once
Method of measurement
observed by the obstetrician
Secondary outcomes
1
Description
persistent Bleeding
Timepoint
once
Method of measurement
observed by obstetricans
Intervention groups
1
Description
Intervention group: patients receiving vaginal misoprostol 400 µg every 6 hours up to three days
Category
Treatment - Drugs
2
Description
control group: the other group is patients receiving vaginal misoprostol 800 µg daily up to three days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Donya Khosravi
Street address
ShahidMadani st after Imam Ali highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
research management
Street address
Chamran highway Tabnak st near Taleghani Hospital
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 of 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
Imam Hossein Hospital
Full name of responsible person
Dr.Donya Khosravi
Position
Academic board
Other areas of specialty/work
Street address
ShahidMadani st after Imam Ali highway
City
Tehran
Postal code
Phone
+98 912 497 1038
Fax
Email
donyakhosravi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hossein Hospital
Full name of responsible person
Dr.Donya Khosravi
Position
Gynecologist and obstetrician
Other areas of specialty/work
Street address
ShahidMadani st after Imam Ali highway
City
Tehran
Postal code
Phone
+98 912 497 1038
Fax
Email
donyakhosravi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Hossein Hospital
Full name of responsible person
Dr. Donya Khosravi
Position
Gynecologist and obstetrician
Other areas of specialty/work
Street address
Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 912 497 1038
Fax
Email
donyakhosravi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)