Comparison of vaginal misoprostol, combination of vaginal misoprostol and letrozole and combination of misoprostol and laminaria for preoperative cervical ripening in under second trimester abortions
Objectives: Comparison of the efficacy of vaginal misoprostol with and without letrozole and combination of misoprostol and laminaria for preoperative cervical ripening among women with under second trimester abortion. Design: In this interventional study, 120 pregnant women under 20 weeks of gestational age who are candidates for therapeutic abortion will be selected and divided into three groups using block randomization method (n=40 in each group).
Inclusion criteria: Under 20 weeks pregnancy and fetal death. Exclusion criteria: Cesarean section history; adrenal diseases; asthma; history of thromboembolism.
Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen. Setting and conduct: One group will receive vaginal misoprostol alone (produced by Pfizer Company), 600 μg every 4 hours for 5 days for women in the gestational age of 13 weeks or less and 200 μg every 4 hours for 5 days in women with the gestational age of 14 - 20 weeks and the second group will receive oral placebo and vaginal misoprostol (like the first group), also they will receive 5 mm laminaria (produced by Cytotec Company) for 6 hours as well. In the third group, oral letrozole (Iran Hormon Company), 10 mg daily in combination with cervical placebo will be prescribed on first and second day and in third day, patients will be hospitalized and receive vaginal misoprostol (like the first group) and third dose of oral letrozole. Patients will regularly be examined every 4 hours and in the absence of abortion, vaginal misoprostol will be repeated after 4 hours. Eight hours after intervention, patients will be assessed using transvaginal ultrasound and no report of products of conception (POC) will be considered as complete abortion and the patient will be discharged. Otherwise, patients will be assessed by transvaginal ultrasound again on next day. For patients who have uncompleted expulsion of POC, curettage abortion will be done. For every patient, pain intensity on the VAS scale will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100923559N6
Registration date:2016-12-30, 1395/10/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-30, 1395/10/10
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vaginal misoprostol, combination of vaginal misoprostol and letrozole and combination of misoprostol and laminaria for preoperative cervical ripening in under second trimester abortions
Public title
Use of vaginal misoprostol with and without letrozole and combination of misoprostol and laminaria for preoperative cervical ripening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Under 20 weeks pregnancy and fetal death. Exclusion criteria: Cesarean section history; adrenal diseases; asthma; history of thromboembolism
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple 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 Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
53141-56198
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.ARUMS.REC.1395.55
Health conditions studied
1
Description of health condition studied
Medical abortion
ICD-10 code
000-008
ICD-10 code description
Medical abortion
Primary outcomes
1
Description
Fetus abortion
Timepoint
Eight hours after the intervention, and every twenty-four hours up to three days if the abortion doesn't occur
Method of measurement
Transvaginal Ultrasonography
Secondary outcomes
1
Description
Pain
Timepoint
Every four hours until abortion occurs and at the time that abortion occurs
Method of measurement
Visual analog scale
Intervention groups
1
Description
Intervention group 1: Vaginal misoprostol, produced by Pfizer Company, 600 μg every 4 hours for 5 days in women with the gestational age of 13 weeks or less and 200 μg every 4 hours for 5 days in women with the gestational age of 14 -20 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral letrozole, produced by Iran Hormon Company, 10 mg daily and vaginal misoprostol, produced by Pfizer Company, 600 μg every 4 hours for 5 days for women in the gestational age of 13 weeks or less and 200 μg every 4 hours for 5 days in women with the gestational age of 14 - 20 weeks.
Category
Treatment - Drugs
3
Description
Intervention group 3: vaginal laminaria, produced by Cytotec Company, 5mm for 6 hours and vaginal misoprostol, produced by Pfizer Company, 600 μg every 4 hours for 5 days for women in the gestational age of 13 weeks or less and 200 μg every 4 hours for 5 days in women with the gestational age of 14 - 20 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Dr. Mahsa Valaee
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
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, Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Mahsa Valaee
Position
Gynecology Asisstant
Other areas of specialty/work
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3324 8888
Fax
Email
mshpartovi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Fariba Kahnamoee Agdam
Position
gynecologist, Gynecology Department
Other areas of specialty/work
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Postal code
5615783134
Phone
+98 45 3324 8888
Fax
Email
f.kahnamuee.a@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Mahsa Valaee
Position
Gynecology Asisstant
Other areas of specialty/work
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Postal code
Phone
+98 45 3324 8888
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)