Objective: investigation the success rate of Letrozole in combination with Misoprostol in medical abortion by using the synergistic effect of drugs in inducing abortion.
Setting and conduct:
This study is a prospective clinical trial, double blind and randomization, with control group (placebo). The study will be performed in the Hospitals of Mashhad University of Medical Sciences on pregnant women who are undergoing medical abortion. The randomization is done by using closed envelopes.
Inclusion criteria: age over 18 years; twenty weeks gestational age based on ultrasound; hemoglobin over 10 mg/dl; diastolic blood pressure less than 95 mm/hg; no history of thrombolytic, no history of cancer and no history of liver disease. Exclusion criteria: asthma; blood pressure; porphyritic; breast; liver disease; IUD existence; smoking more than twenty cigarettes a day. Participants: Pregnant women Interventions: letrozole / misoprostol. Primary outcome variables: abortion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042933680N1
Registration date:2017-06-26, 1396/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of letrozole / misoprostol compared with placebo / misoprostol in success rate of medical abortion
Public title
The effect of letrozole / misoprostol compared with placebo / misoprostol in success rate of medical abortion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Upper 18 years old; Twenty weeks gestational age based on ultrasound; Hemoglobin greater than 10 mg/dl; Diastolic blood pressure less than 95 mmHg; No history of thrombolytic, Cancer and liver disease.
Exclusion criteria:Asthma; Hypertension; Porphyritic; Breast; liver disease; Having IUD; Smoking upper twenty cigarettes a day.
Age
From 18 years old to 50 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Mashhad University of Medical sciences
Street address
Daneshgah St, Department of Ghoreish
City
Mashhad
Postal code
13944-91388
Approval date
2017-04-26, 1396/02/06
Ethics committee reference number
IR.MUMS.fm.REC.1395.569
Health conditions studied
1
Description of health condition studied
Medical abortion
ICD-10 code
O08.9
ICD-10 code description
Complication following abortion and ectopic and molar pregnancy, unspecified
Primary outcomes
1
Description
Abortion
Timepoint
after intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
after Intervention
Method of measurement
sonography, Less than twenty millimeters is considered as complete abortion and endometrial thickness greater than twenty millimeters is considered as incomplete abortion
Intervention groups
1
Description
The intervention group will receive daily oral dose of 10 mg letrozole 2 days before hospitalization. Third dose of one will receive in time of hospitalization.
Category
Treatment - Drugs
2
Description
The control group will receive daily oral dose of 10 placebo 2 days before hospitalization. Third dose of one will receive in time of hospitalization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital's Teaching of Imam Reza (AS)
Full name of responsible person
Dr Taheri
Street address
Shariati Square. Imam Reza (AS) Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marjan Ardakanian
Street address
Daneshgah St, Ghoreishi Department
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Taheri
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Square TAGHIABAD, Imam Reza (AS) Hospital, Department of Obstetrics and Gynecology
City
Mashhad
Postal code
9137913316
Phone
+98 51 32608
Fax
Email
golhasanif1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farideh Akhlaghi
Position
Assistant professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Square of Taghi Abad, Imam Reza Hospital, Department of Obstetrics and Gynecology
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
Akhlaghif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Golhasani
Position
Master
Other areas of specialty/work
Street address
Square of Taghi Abad, Imam Reza Hosital, Woman Health Research Center.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2631
Fax
Email
golhasanif1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)