Objectives:
Induced abortion is one of the most common subjects which has been investigated widely in obstetrics and gynecology field. The aim of this study is to compare the effect of Letrozole plus Misoprostol with Misoprostol alone on first trimester abortion induction.
Design:
In this clinical trial, after documentation of general information such as age, weight and medical history, 70 pregnant women who are candidate for therapeutic abortion under 12 weeks of gestational age, will be randomly divided into two groups of control or trial.
Setting and conduct:
After admitting in the hospital, the patients in the control group will receive Misoprostol vaginally for abortion induction. Letrozole tablet will be given to the patients of the trial group for three days, then the patients will be admitted at the third day and receive Misoprostol vaginally.
Major inclusion and exclusion criteria:
Pregnant women with 18 to 34 years of age with nonviable pregnancy under 12 weeks from the first day of last menstrual period. Without history of systemic diseases or presence of acute conditions that require any urgent intervention and treatment.
Intervention:
Receiving Letrozole plus Misoprostol or Misoprostol alone.
Main outcome measures (variables):
Patients will be monitored for 24 hours after taking Misoprostol and will be evaluated for gastrointestinal side effects and the interval between induction and abortion beginning, opening of cervical internal os and complete abortion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050119037N8
Registration date:2015-06-01, 1394/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-01, 1394/03/11
Registrant information
Name
Mahdieh Yousef-Zanjani
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6004
Email address
yusefi.mahdieh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Letrozole plus Misoprostol with Misoprostol alone on induction of first trimester abortion in pregnant women
Public title
Comparison the effect of Letrozole with Misoprostol on induction of first trimester abortion in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with 18 to 34 years of age with nonviable pregnancy under 12 weeks from the first day of last menstrual period.
Exclusion criteria:
History of systemic diseases or presence of acute conditions that require any urgent intervention and treatment.
Age
From 18 years old to 34 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the candidate patients for therapeutic abortion under 12 weeks will be randomly divided into one of the groups (trial or control) by usage of colored carts.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2013-10-15, 1392/07/23
Ethics committee reference number
7931
Health conditions studied
1
Description of health condition studied
Therapeutic Abortion
ICD-10 code
O04
ICD-10 code description
Therapeutic/Medical Abortion (termination of pregnancy)
Primary outcomes
1
Description
The interval between induction and abortion beginning and opening of cervical internal os
Timepoint
Until 24 hours after receiving Misoprostol, every 1 hour
Method of measurement
Physical examination
2
Description
The interval between induction and complete abortion
Timepoint
Until 24 hours after receiving Misoprostol, every 1 hour
Method of measurement
Sonography
Secondary outcomes
1
Description
Gastrointestinal problems (nausea or vomiting)
Timepoint
From receiving Letrozole until 24 hours after receiving Misoprostol
Method of measurement
Objective
Intervention groups
1
Description
First intervention group (control):
Receiving 8 Misoprostol 100 mcg tablets as a single vaginal dose from Abureyhan drug manufacturing company, Iran
Category
Treatment - Drugs
2
Description
Second intervention group (trial):
Receiving 4 Letrozole 2.5 mg tablets daily for 3 days (orally), from Abureyhan drug manufacturing company, Iran
Plus
Receiving 8 Misoprostol 100 mcg tablets as a single vaginal dose from Abureyhan drug manufacturing company, Iran
(with third day dose of Letrozole)