Protocol summary

Summary
The purpose of this study was to compare oral and vaginal misoprostol in pregnant women who referred to Besat Hospital of Sanandaj in 1393 for legal abortion. Total of 70 pregnant women that with Legal Medicine permission were referred to Besat Hospital of Sanandaj in order to pregnancy termination were selected. Inclusion criteria included pregnant women who were candidates of pregnancy termination with the permission of legal Medicine and exclusion criteria were pregnant women who were breastfeeding, women with severe liver disease, chronic pulmonary disease, Mitral valve stenosis, history of allergy to prostaglandins, inflammatory disease of intestines, asthma, glaucoma, hypertension, and severe bleeding. After obtaining written informed consent they were randomly divided into 2 oral misoprostol and vaginal misoprostol groups using 2 block method and table of random numbers. In oral group 200 micrograms of misoprostol was used every 6 hours up to 6 times up to 36 hours and also in vaginal group 200 micrograms of misoprostol was used every 6 hours up to 6 times up to 36 hours. To double blind the study placebo was used. In oral group, vaginal placebo and in vaginal group oral placebo was used simultaneously. Researcher and the participants in the study were not aware of the drug or placebo. At the end of the study, the efficacy of treatment method namely the rate of pregnancy products excretion and complications (bleeding, fever,uterus perforation) were measured in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110812789N9
Registration date: 2014-12-13, 1393/09/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-13, 1393/09/22
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-11-06, 1393/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral versus vaginal misoprostol for legal abortion in pregnant women: A double blind randomized clinical study
Public title
Comparison of oral versus vaginal misoprostol for legal abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women who are candidates of pregnancy termination with the permission of legal Medicine. Exclusion criteria : pregnant women who are breastfeeding, women with severe liver disease, chronic pulmonary disease, Mitral valve stenosis, history of allergy to prostaglandins, inflammatory disease of intestines, asthma, glaucoma, hypertension, and severe bleeding.
Age
From 15 years old to 45 years old
Gender
Female
Phase
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)
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 Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
Postal code
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
14/26288

Health conditions studied

1

Description of health condition studied
Medical abortion
ICD-10 code
O05
ICD-10 code description
termination of pregnancy

Primary outcomes

1

Description
Pregnancy Exertion
Timepoint
Beginning of the study, every 6 hours up to 36 hours
Method of measurement
dilatation of cervix-contraction and hemorrhage

Secondary outcomes

1

Description
Fever
Timepoint
Every one hour until the last dosage
Method of measurement
Clinical Examination

2

Description
uterus perforation
Timepoint
Every one hour until the last dosage
Method of measurement
Clinical examination by Gynecology resident

3

Description
Amount of bleeding
Timepoint
The start of the intervention up to 36 hours
Method of measurement
Observation and clinical examination

Intervention groups

1

Description
Intervention group: misoprostol 200 mcg tablets (Cytotec) were used vaginally every 6 hours up to 6 times up to 36 hours. Tablets were inserted into the depth of vagina by the midwife. Generic name: MisoprostolBrand name: Cytotec
Category
Treatment - Drugs

2

Description
Control group: misoprostol 200 mcg tablets (Cytotec) were used orally every 6 hours up to 6 times up to 36 hours. Generic name: Misoprostol Brand name: Cytotec
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Faeze Malak Mohammadi Memar
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Kurdistan University of Medical Sciences
Full name of responsible person
Fardin Gharibi
Street address
Kurdistan University of Medical Sciences, Pasdaran St., Sanandaj, Iran
City
Sanandaj
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, Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Faeze Malak Mohammadi Memar
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
faezeh_malekmohammadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Fariba Farhadifar
Position
Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
simahoma@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Faeze Malak Mohammadi Memar
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Besat Hospital, Keshavarz St., Mardokh Cross Road, Sanandaj, Iran
City
Sanandaj
Postal code
Phone
+98 87 3328 8119
Fax
Email
faezeh_malekmohammadi@yahoo.com
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
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