The aim of current study is to examine the effect of Misoprostol with and without Letrozole in first trimester abortion. In this study 110 pregnant women are selected who are in the first trimester and attend at Rouhani hospital for termination of pregnancy.They are selected according to Inclusion criteria (NULL Pregnancy and etc.) and Exclusion criteria (sever bleeding and etc.) and randomly placed in two groups. In the Intervention group, treatment is performed on an out-patient basis for 2 days with oral Letrozole (made by Iran Hormone Co.), 7.5 mg daily, followed by 800 mcg vaginal Misoprostol (made by SEARLE Co.) on the third day of treatment that is placed in the posterior Fornix. In the control group treatment is performed by placebo (Folic acid as single blind – made by Iran Daru Co.) for 2 days and on the third day 800 mcg vaginal Misoprostol is placed in the posterior Fornix. To use of Misoprostol, each patient is admitted and both of the groups are monitored for 24 hours and then checked by sonography. Excretion of pregnancy products after 7 days is a sign of success in this method. If excretion after 7 days does not happen, it is a sign of failure in this method, and other methods like curettage are used. In current study primary outcomes are considered as complete abortion, time between medication and abortion and need for curettage. Secondary outcomes are drug adverse effects including fever, severe bleeding, diarrhea, Vomiting and skin rash.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412111760N37
Registration date:2014-12-22, 1393/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The compression of Misoprostol effect with and without Letrozole in first trimester abortion: A randomized clinical trial study
Public title
The compression of Misoprostol effect with and without Letrozole in first trimester abortion: A randomized clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Following 12 weeks of pregnancy; Reason for termination of pregnancy, such as missed abortion; Pregnancy NULL; Therapeutic abortion legal authorization and consent of patients
Exclusion criteria:
Pain and bleeding; Drug sensitivity to misoprostol; Severe anemia; Coagulopathy or taking anticoagulants; Active liver disease; Cardiovascular disease and uncontrolled seizures; Adrenal disease, or a history of corticosteroid use
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2014-01-14, 1392/10/24
Ethics committee reference number
3609
Health conditions studied
1
Description of health condition studied
Termination of pregnancy in the first trimester
ICD-10 code
P96.4
ICD-10 code description
Termination of pregnancy, fetus and newborn
Primary outcomes
1
Description
abortion
Timepoint
The start of the intervention up to 24
Method of measurement
Ultrasound
2
Description
Time between medication abortion
Timepoint
The start of the intervention up to 24
Method of measurement
Ultrasound
3
Description
The need for curettage
Timepoint
Seven days after abortion
Method of measurement
Clinical
Secondary outcomes
1
Description
Side effects
Timepoint
Intervention to 24 hours after administration
Method of measurement
Clinical
Intervention groups
1
Description
Intervention Group:
In the Intervention group treatment is being performed on an out-patient basis for 2 days with Letrozole (made by Iran Hormone Co.) as 7.5 mg orally once a day, and on the third day 800 mcg vaginal Misoprostol (made by SEARLE Co.) is being placed in the posterior Fornix.
Category
Treatment - Drugs
2
Description
Control Group:
In the control group treatment is being performed by placebo (folic acid as single blind – made by Iran Daru Co.) for 2 days and on the third day 800 mcg vaginal Misoprostol is being placed in the posterior Fornix.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Zeinab Azmoodeh Fard
Street address
Ayatollah Rouhani Hospital, Gangafroz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Babol University of Medical Sciences, Ganjafroz Avenu
City
Babol
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 and Technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Zeinab Azmoodeh Fard
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Ayatollah Rouhani Educational Center
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
zeinabazmoodeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahla Yazdani
Position
Gynecologist
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Ayatollah Rouhani Educational Center
City
Babol
Postal code
Phone
+98 11 3223 8301
Fax
Email
Shahla_yazdani_1348@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafroz Avenu Babol
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)