This study will be conducted with aim to Comparative evaluation of the effectiveness and side effects of different ways of misoprostol Prescribed in the termination of the second trimester of pregnancy. This study is a non blinded clinical trial. The study population will be consisted of pregnant women at 22-13 weeks of pregnancy that due to intrauterine death or congenital anomalies are candidates for termination of pregnancy, that 180 persons in available method is selected and randomly will be assigned to three groups. In all three groups the patients' vital signs will be recorded. In the first group misoprostol 400 mcg is selected that in every 4 hours up to 5 doses will be Prescribed in the form of vaginally. In the second group misoprostol 400 mcg is selected that in every 4 hours up to 5 doses in the form of orally will be Prescribed. In the thired group misoprostol 400 mcg is selected that in every 4 hours up to 5 doses will be Prescribed sublingual. Vital signs and adverse effects in beginning of each dose (hour 1) and 4 hours after Prescribe of each dose in patients will be monitored. Then the interval between Prescrition of the first dose of misoprostol and discharge of pregnancy products will be recorded for each patient. In this study routinely ,for all patients curettage is performed in the operating room and patients' hemoglobin also will be control 6 hours after curettage.
Inclusion criteria: singleton pregnancy;gestational age 13 to 22 with an indication for termination of pregnancy in medical procedures; Chorioamnionitis.
Exclusion criteria: patients with a history of caesarean section; mother serious systemic and chronic disease , cardiovascular, renal diseases ; known sensitivity to prostaglandins and coagulopathy; uncontrolled seizure disorders; hemolytic disease
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015123014333N47
Registration date:2016-01-17, 1394/10/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness and side effects of different ways of misoprostol Prescribed in the termination of the second trimester of pregnancy
Public title
Comparative evaluation of the effectiveness and side effects of different ways of misoprostol Prescribed in the termination of the second trimester of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy;gestational age 13 to 22 with an indication for termination of pregnancy in medical procedures; Chorioamnionitis.
Exclusion criteria: patients with a history of caesarean section; mother serious systemic and chronic disease , cardiovascular, renal diseases ; known sensitivity to prostaglandins and coagulopathy; uncontrolled seizure disorders; hemolytic disease
Age
From 3 months old to 6 months old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee Moral, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
Kums.Rec.1394.217
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
Ague
Timepoint
Baseline and 4 hours after drug administration
Method of measurement
By asking of patient
2
Description
Abdominal pain
Timepoint
Baseline and 4 hours after drug administration
Method of measurement
By asking of patient
3
Description
Nausea
Timepoint
Baseline and 4 hours after drug administration
Method of measurement
By asking of patient
4
Description
Vaginal bleeding
Timepoint
Baseline and 4 hours after drug administration
Method of measurement
By asking of patient and doctor observation
5
Description
Vomiting
Timepoint
Baseline and 4 hours after drug administration
Method of measurement
By asking of patient
6
Description
During the induction of abortion
Timepoint
From the intervention to discharge pregnancy products
Method of measurement
Based on clinical signs and doctor observation
Secondary outcomes
empty
Intervention groups
1
Description
In the first group misoprostol 400 mcg is selected that in every 4 hours up to 5 doses will be Prescribed in the form of vaginally.Vital signs and adverse effects in beginning of each dose (hour 1) and 4 hours after Prescribe of each dose in patients will be monitored. Then the interval between Prescrition of the first dose of misoprostol and discharge of pregnancy products will be recorded for each patient
Category
Treatment - Drugs
2
Description
In the second group misoprostol 400 mcg is selected that in every 4 hours up to 5 doses in the form of orally will be Prescribed. Vital signs and adverse effects in beginning of each dose (hour 1) and 4 hours after Prescribe of each dose in patients will be monitored. Then the interval between Prescrition of the first dose of misoprostol and discharge of pregnancy products will be recorded for each patient
Category
Treatment - Drugs
3
Description
In the thired group misoprostol 400 mcg is selected that in every 4 hours up to 5 doses will be Prescribed sublingual. Vital signs and adverse effects in beginning of each dose (hour 1) and 4 hours after Prescribe of each dose in patients will be monitored. Then the interval between Prescrition of the first dose of misoprostol and discharge of pregnancy products will be recorded for each patient
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ronak Rezaei
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Anisodole Nankali
Position
Obstetricians
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
anankali@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)