1. Home
  2. Approved trials
  3. » فارسی

The effect of adding hyoscine to vaginal misoprostol on shotening the induction time of abortion

Protocol summary

Summary
To investigate the effect of adding hyoscine to vaginal misoprostol on shortening the duration of induction of abortion. 126 pregnant women were indicated for induction of abortion and their gestational age were under 20 weeks.Patients were divided randomly in two equal groups.In one group 400µg vaginal misoprostol every 6 hours (n=63) and the other group 400 µg vaginal misoprostol with hyoscine 20 mg intra venous(n=63) were administered.Their complains such as nausea ,vomiting,diarrhea,vaginal bleeding,fever,hemoglobin changes, getting pain killer,the duration of abortion induction ,hospitalized duration were compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207259491N3
Registration date: 2012-08-22, 1391/06/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-22, 1391/06/01
Registrant information
Name
Reyhaneh Ramezaninezhad
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6374
Email address
rramezaninezhad@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-05-17, 1391/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding hyoscine to vaginal misoprostol on shotening the induction time of abortion
Public title
The effect of adding hyoscine to vaginal misoprostol on shotening the induction time of abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Blighted ovum;Missed abortion;anomal fetus Exclusion criteria:Sever anemia;Quagolopathy;Anti quagulant drugs;Actie liver disease;Heart disease;Uncontrolled seizure;Adrenal disease;IUD;Sensevity to prostaglandins and hyoscine
Age
From 17 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
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
Qazvin University of Medical Science
Street address
Bahonar bolvar
City
Qazvin
Postal code
34197-59811
Approval date
2012-06-10, 1391/03/21
Ethics committee reference number
28/20/5943

Health conditions studied

1

Description of health condition studied
Induction of abortion
ICD-10 code
p96.4
ICD-10 code description
Termination of pregnancy, affecting fetus and newborn

Primary outcomes

1

Description
Opening of internal OS of cervix
Timepoint
Before vaginal misoprostol,after vaginal bleeding
Method of measurement
Vaginal exam,open or close of internal os of cervix

Secondary outcomes

1

Description
Nausea,vomiting,fever,vaginal bleeding,taking pain killers,hemoglobin changes,diarrhea
Timepoint
after putting vaginal misoprostole the symptoms asked,hemoglobin measured on admission and 6hours after curtage
Method of measurement
physcian

Intervention groups

1

Description
Intervention:400 microgram vaginal misoprostal every 6hours with single dose hyoscine 20mg intra venous take.
Category
Treatment - Drugs

2

Description
Control:400 microgram vaginal misoprostol every 6 hours with single dose 20 cc normal saline taken intra venus in serum.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Samira Ghaffari
Street address
Taleghani Street
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin university of Medical Science
Full name of responsible person
Mrs Shamekhi
Street address
Bahonar Bolvar
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin university of Medical Science
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
Kosar Hospital
Full name of responsible person
Haj Seyyed Javadi Ezzatolsadat
Position
Assistant Professor of Qazvin University of Medical Scinece
Other areas of specialty/work
Street address
Taleghani Street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
rramezaninezhad@qums.ac.irsamira_ghaffari@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kosar HOSPITAL
Full name of responsible person
Hajseyyed Javadi Ezzatosadat
Position
Assistant Professor of Qazvin University of Mwdical Scinece
Other areas of specialty/work
Street address
Taleghani Street
City
Qazvin
Postal code
Phone
+98 28 1223 6374
Fax
Email
rramezaninezhad@qums.ac.irsamira_ghaffari@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kosar hospital
Full name of responsible person
Samira Ghaffari
Position
Resident of obstetric and Gynecology of Qazvin University Of Medical Scinence
Other areas of specialty/work
Street address
Nomber 22, Ziba Street, Shariati Street
City
Tehran
Postal code
1948846713
Phone
+98 21 2289 2560
Fax
Email
samira_ghaffari@hotmail.com,rramezaninezhad@qums.ac.ir
Web page address

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
Loading...