This clinical trial study is designed to aid in selection of most effective way of prescribe of misoprostol that had least complications.This double blind study will do on 140 pregnant women 18-35 yearrs with singleton pregnancy IUFD below 14 w and BMI 19.8-26 kgr/m2 that divided accidentally in two 70 cases groups. first group received rectal misoprostol and second group oral misoprostol in similar doses 600-300-300 microgram/6 hours and effects of drug in inducing of incomplete abortion, complete abortion .ripening of uterine cervix and side effect of drug such as nausea ,vomiting.fever and so time of effect of drug will compared in two ways.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042533635N1
Registration date:2017-06-21, 1396/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
nahid sakhavar
Name of organization / entity
zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 33419522
Email address
sakhavarn@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology of Zahedan university of medical sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of rectal and oral misoprostol in First Trimester of Pregnancy Induced Abortion
Public title
Comparison the effect of rectal and oral misoprostol in First Trimester of Pregnancy Induced Abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Including factors: singleton pregnancy ,gravid 2 -4,without cervical dilatation and bleeding or tissue passing,report of IUFD in two sonographys,gestational age below 14 w,BMI Between 19.8-26 kg/m2
Excluding factors:background diseases related with study such as overt DM,chronic Hypertension,SLE,fever or chorioamnionitis signs,using unusual drugs in pregnant women,addiction,...
Age
From 18 years old to 35 years old
Gender
Female
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
clinical trial in hospital for selection the better treatment
Secondary Ids
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
zahedan university of medical sciences
Street address
Dr hesabi square,khaligfars Blvd,administrative complex of zahedan medical sciences university pardis, Zahedan,Iran
City
zahedan
Postal code
98167-43463
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.ZAUMS.REC.1395.100
Health conditions studied
1
Description of health condition studied
induced abortion
ICD-10 code
094-099
ICD-10 code description
other obstetric conditions-not elsewhere classified
Primary outcomes
1
Description
complete abortion
Timepoint
during hospitalization
Method of measurement
uterine sonogeraphy
2
Description
incomplete abortion
Timepoint
during hospitalization
Method of measurement
uterine sonogeraphy
3
Description
cervical ripening
Timepoint
during hospitalization and in time of curettage
Method of measurement
passing the number 8 bugie
4
Description
nausia
Timepoint
during hospitalization
Method of measurement
observation and patient expression
5
Description
vomitting
Timepoint
during hospitalization
Method of measurement
observation
6
Description
fever
Timepoint
during hospitalization
Method of measurement
body temperature > 38 c
7
Description
time of drug effect
Timepoint
repetitive visit and patient expression
Method of measurement
observation and examination
Secondary outcomes
empty
Intervention groups
1
Description
Misoprostol tab 200 microgram with primary dose of 600 and two dose of 300 per 6 hours in first group by rectally
Category
Treatment - Drugs
2
Description
Misoprostol tab 200 microgram with primary dose of 600 and two dose of 300 per 6 hours in second group by orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ali ebne abitaleb hospital zahedan
Full name of responsible person
nahid sakhavar
Street address
khalijfars highway,salamat blvd,speciality hospital of ali ebne abitaleb
City
zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
deputy of research and technology of zahedan university of medical sciences
Full name of responsible person
hoshang rafighdoost
Street address
Iran,Zahedan,Dr hesabi square,pardis administrative complex of zahedan medical university
City
zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
deputy of research and technology of zahedan 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
zahedan university of medical sciences
Full name of responsible person
mina khaje
Position
medical student
Other areas of specialty/work
Street address
zahedan university of medical sciences
City
zahedan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
+98 54 3329 5570
Email
nsakhavar@yahoo.co.uk
Web page address
/htto://alihos.zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
associated professor
Full name of responsible person
nahid sakhavar
Position
associate professor of obstetric and gynecology
Other areas of specialty/work
Street address
Iran,Zahedan,Ali ebne abitaleb hospital.obstetric and gynecology department
City
zahedan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
+98 54 3329 5570
Email
sakhavarn@zaums.ac.ir
Web page address
/http://alihos.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
zahedan university of medical sciences
Full name of responsible person
nahid sakhavar
Position
associate professor of obstetric and gynecology
Other areas of specialty/work
Street address
Iran,Zahedan,Ali ebne abitaleb hospital.obstetric and gynecology department
City
zahedan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
+98 54 3329 5570
Email
sakhavarn@zaums.ac.ir
Web page address
/http://alihos.zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)