This study will be done with aime to investigate the effect of misoprostol with letrozole to induction abortion in the second trimester of pregnancy. This study is a double-blind clinical trial. The study population will be pregnant women who refer to Imam Reza hospital in Kermanshah city with gestational age of 13 -23 week's, which has indicated termination of pregnancy in drug method and 120 persons will selected and randomly will assigned to two experimental and control groups. In the experimental group letrozole tablets orally at a dose of 2 .5 mg in the form of two tablets given every 12 hours for two days.The beginning of the third day Misoprostol tablets at a dose of 100 mg as 4 tablets every 6 hours, up to 3 doses means 1200 micrograms given vaginally. The control group will receive 8 placebo tablets on two consecutive days, 2 tablets every 12 hours given. Then from the third day, vaginal misoprostol of 100 micrograms as a 4 tablets with a maximum of 3 doses will given every 6 hours. Blood pressure, heart rate and body temperature measured every 2 hours. Fever, nausea, diarrhea, abdominal pain, bleeding and tissue rejection time will also be recorded. Then the time interval between discharge pregnancy products from the first prescribed dose of misoprostol will be recorded for each patient. Patient initial hemoglobin and post-abortion hemoglobin will be measured. In this study for all patients curettage is performed in the operating room routinely and patients' hemoglobin control also will be 6 hours after curettage. Inclusion criteria: gestational age of 13 to 22 with an indication for termination of pregnancy in medical method; Chorioamionitic. Exclusion criteria: patients with a history of caesarean section; Maternal serious chronic systemic and chronic disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015123114333N48
Registration date:2016-03-02, 1394/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-02, 1394/12/12
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
2016-01-25, 1394/11/05
Expected recruitment end date
2017-07-27, 1396/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of misoprostol with letrozole and without letrozole to induce abortion in the second trimester of pregnancy
Public title
Comparison investigation of the effect of Letrozole misoprostol to induce abortion in the second trimester of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age of 13 to 22 with an indication for termination of pregnancy in medical method; Chorioamionitic.
Exclusion criteria: Patients with a history of caesarean section; Maternal serious chronic systemic and chronic disease; Cardiovascular disease.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of 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
2015-01-16, 1393/10/26
Ethics committee reference number
45253/پ/7/420
Health conditions studied
1
Description of health condition studied
Termination of pregnancy in the second trimester
ICD-10 code
O04
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Duration of induction to abortion
Timepoint
From admission until 48 hours later
Method of measurement
Doctor observation
2
Description
Blood pressure
Timepoint
Baseline, every 2 hours, discharge time
Method of measurement
Manometer
3
Description
Heart rate
Timepoint
Baseline, every 2 hours, discharge time
Method of measurement
By doctor
4
Description
Temperature
Timepoint
Baseline, every 2 hours, discharge time
Method of measurement
By thermometer
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group letrozole tablets orally at a dose of 2 .5 mg in the form of two tablets given every 12 hours for two days. At the beginning of the third day Misoprostol tablets at a dose of 100 mg as 4 tablets every 6 hours, up to 3 doses means 1200 micrograms given vaginally.
Category
Treatment - Drugs
2
Description
The control group will receive 8 placebo tablets on two consecutive days , 2 tablets every 12 hours given. Then on the third day, vaginal misoprostol of 100 micrograms as a 4 tablets every 6 hours with a maximum of 3 doses will given
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Negin hajiali Akbari
Street address
Emam Reza Hospital, Parastar Boulevard
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)