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Comparative study of effect of misoprostol moistened with normal saline and acetic acid for14 to 26 weeks pregnant women termination.

Protocol summary

Summary
Comparative study on misoprostol moistened with normal saline and acetic acid for second-trimester pregnancy termination. Pregnant women at 14 to 26 weeks of pregnancy who admitted for induced abortion with vaginal misoprostol. Intervention control, 94 patients: (47 patients in intervention group and 47 patient in control group), double blinded (patients and rescearchers), Randomised(by randomised list produced by computer), clinical trial. Misoprostol moistened with acetic acid 400 microgram, q4hour, maximum 5doses to some patients and moistened with normal saline, 400 microgram q4hour, to others will be given randomised. If abortion is occurred: success in abortion at 24 hours and after first dose of misoprostol, side effects, use to abortion interval, doses, in both groups will compare. Misoprostol (prostaglandin E1 analog) moistened with acetic acid, (tablet 200 microgram)400 microgram, 2tablets q4hour, maximum 5doses vaginaly adminestrated for intervention group and moistened with normal salin for control group. Success in termination of pregnancy at first 24 hours, success in termination of pregnancy after first dose, induction interval to delivery, dose of misoprostol used to termination, side effects: nausa, vomiting, shaking.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082635898N1
Registration date: 2017-10-17, 1396/07/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Bibi Elham Rezaei Askariye
Name of organization / entity
Mashhad university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 3007
Email address
rezaeiae921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of effect of misoprostol moistened with normal saline and acetic acid for14 to 26 weeks pregnant women termination.
Public title
Effect of misoprostol moistened with normal saline and acetic acid for second-trimester pregnancy termination.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion: pregnant women at 14 to 26 weeks of pregnancy who admitted for induced abortion with vaginal misoprostol. exclusion criteria :not respond to misoprostol;start of spontaneous abortion; contraindication of medical termination like previa placenta;prostaglandin contraindication like hyper sensivity,asthma, glucoma, cardiovascular disease.
Age
From 9 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not 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
Ghoraishy Building, Daneshgah St.
City
Mashhad
Postal code
Approval date
2015-08-19, 1394/05/28
Ethics committee reference number
1394.255

Health conditions studied

1

Description of health condition studied
Induce abortion of second trimester of pregnancy
ICD-10 code
O07.9
ICD-10 code description
Other and unspecified failed attempted abortion, without complication

Primary outcomes

1

Description
Success in termination of pregnancy at first 24 hours.
Timepoint
Every 4 hour from intervention.
Method of measurement
Questionnaire, hour.

2

Description
Success in termination of pregnancy after first dose.
Timepoint
Every 4 hours from intervention.
Method of measurement
Questionnaire, hour.

Secondary outcomes

1

Description
Induction interval to delivery.
Timepoint
During 72 hours from intervention.
Method of measurement
Questionnaire, hour.

2

Description
Dose of misoprostol used to termination.
Timepoint
During 72 hour from intervention.
Method of measurement
Questionnaire

3

Description
Side effects, nausa, vomiting, shaking.
Timepoint
During 48 hours from intervention.
Method of measurement
Questionnaire, check list.

Intervention groups

1

Description
Misoprostol(prostaglandin E1 analog) moistened with acetic acid, (tablet 200 microgram)400 microgram, 2tablets q4hour, maximum 5doses vaginaly adminestrated for intervention group
Category
Treatment - Drugs

2

Description
Misoprostol (prostaglandin E1 analog) moistened with normal salin, (tablet 200 microgram)400 microgram, 2tablets q4hour, maximum 5doses vaginaly adminestrated for control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Omolbanin Women Hospital
Full name of responsible person
Dr. Faride Akhlaghi
Street address
Zarine intersection
City
Mashhad

2

Recruitment center
Name of recruitment center
Qaem hospital
Full name of responsible person
Dr. Faride Akhlaghi
Street address
Taghi abad st.
City
Mashhad

3

Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Dr. Leili Hafizi
Street address
Emam reza square
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoraishy Building, Daneshgah St.
City
Mashhad
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, 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
Bibi Elham Rezaei Askariye
Position
Resident of obstrictic & gynecology
Other areas of specialty/work
Street address
Ghoraishy Building, Daneshgah St.
City
Mashhad
Postal code
9138813944
Phone
+98 51 3601 4875
Fax
+98 51 3841 3006
Email
rezaeiae921@mums.ac.ir; rezaeidrel@gmail.com; presidentoffice@mums.ac.ir
Web page address
web@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Univercity of Medical Sciences
Full name of responsible person
Faride Akhlaghi
Position
Proffessor
Other areas of specialty/work
Street address
Ghoraishy Building, Daneshgah St.
City
Mashhad
Postal code
9138813944
Phone
+98 51 3223 1444
Fax
0o985138413006
Email
akhlaghif@mums.ac.ir; presidentoffice@mums.ac.ir
Web page address
web@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Bibi Elham Rezaei Askariye
Position
Resident of obstrictic & gynecology
Other areas of specialty/work
Street address
Ghoraishy Building, Daneshgah St.
City
Mashhad
Postal code
9138813944
Phone
+98 51 3601 4875
Fax
+98 51 3841 3006
Email
rezaeiae921@mums.ac.ir; rezaeidrel@gmail.com
Web page address
web@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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