Protocol summary

Summary
The aim of this study is comparison of vaginal versus sublingual Misoprostol in successful termination of pregnancy. This study will be done on 268 pregnant women admitted in Alzahra hospital-Rasht 2011-2012. Inclusion criteria are 12-24 weeks single pregnancy confirmed with certain LMP and < 20 weeks sonography. Exclusion criteria is Known sensitivity to prostaglandins, previous caesarian section, vaginal bleeding and placenta previa, Parity > 3. Women randomly will be divided in two groups. One group will be treated with sublingual misoprostol and vaginal placebo and another group will be treated with vaginal misoprostol and sublingual placebo. The doses are given each 3 hours to 24 hours and if pregnancy isn’t terminated, another doses should be continued each 3 hours to 48 hours and then if pregnancy still isn’t terminated within 48 hours, other methods will be used such as high dose oxytocin or historotomy. Vital signs and side effects (such as nausea, headache, breast tenderness, diarrhea, chilling, fever frequency of needing to analgesics, vomiting) will be control every 3 hours and register. The main outcome is the time interval between drug using to pregnancy termination and second outcome is abortion within 24 hours, abortion within 48 hours, comparing the pain onset after drug using in two groups and comparing the side effects. Data will be evaluated with statistical methods. The time interval of drug therapy to pregnancy termination will be compare in both groups and data will be evaluated with statistical methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201106213485N3
Registration date: 2011-08-15, 1390/05/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-08-15, 1390/05/24
Registrant information
Name
Forozan Milani
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1722 9328
Email address
milani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Scientific Title :Comparison the effect of vaginal and sublingual Misoprostol in successful termination of pregnancy in 12-24 weeks pregnant women admitted in Alzahra Hospital – Rasht in 2011-2012
Public title
Comparison the effect of vaginal versus sublingual misoprostol in termination of pregnancy of 12-24 weeks
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 12-24 weeks single pregnancy confirmed with certain LMP and > 20 weeks sonography Exclusion criteria : Known sensitivity to prostaglandins (questions such as skin rash, wheels, dyspnea, cough, chest pain, blurred vision); previous caesarian section; Vaginal bleeding; placenta previa; Parity > 3
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 268
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
Ethic committee Guilan University of Medical Sciences
Street address
Vice Chancellor for research, Guilan University of Medical Sciences, Melat st, Namjoo Ave
City
Rasht
Postal code
Approval date
2011-05-28, 1390/03/07
Ethics committee reference number
190013606

Health conditions studied

1

Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O04
ICD-10 code description
Medical abortion

Primary outcomes

1

Description
Comparing the effect of vaginal versus sublingual misoprostol in termination of pregnancy
Timepoint
Each 3 hours to 24 hours then if the pregnancy isn’t terminated misoprostol will be continued each 3 hours to 48 hours
Method of measurement
Observation of fetus expulsion

Secondary outcomes

1

Description
Determining the relative frequency of Abortion within 48 hours after using vaginal misoprostol
Timepoint
Each 3 hours to 48 hours after using sublingual misoprostol
Method of measurement
Measuring the time interval between using sublingual misoprostol to abortion

2

Description
Comparing the relative frequency of abortion within 24 hours in vaginal and sublingual misoprostol using
Timepoint
Each 3 hours to 24 hours
Method of measurement
Measuring the time interval between using vaginal misoprostol and sublingual misoprostol to abortion

3

Description
Determining the relative frequency of Abortion within 24 hours after using vaginal misoprostol
Timepoint
Each 3 hours to 24 hours
Method of measurement
Measuring the time interval between using vaginal misoprostol to abortion

4

Description
Determining the relative frequency of Abortion within 24 hours after using sublingual misoprostol
Timepoint
Each 3 hours to 24 hours
Method of measurement
Measuring the time interval between using sublingual misoprostol to abortion

5

Description
Determining the relative frequency of Abortion within 48 hours after using vaginal misoprostol
Timepoint
Each 3 hours to 48 hours after using sublingual misoprostol
Method of measurement
Measuring the time interval between using sublingual misoprostol to abortion

6

Description
Comparing the relative frequency of abortion within 48 hours after using vaginal and sublingual misoprostol
Timepoint
3 hours to 48 hours after using vaginal and sublingual misoprostol
Method of measurement
Measuring the time interval between using vaginal and sublingual misoprostol to abortion

7

Description
Measuring the time interval after using vaginal misoprostol to pain onset
Timepoint
Each 3 hours
Method of measurement
Pain visual scale

8

Description
Measuring the time interval after using sublingual misoprostol to pain onset
Timepoint
Each 3 hours
Method of measurement
Pain visual scale

9

Description
Comparing the time interval between use vaginal and sublingual misoprostol and pain onset
Timepoint
Each 3 hours
Method of measurement
Pain visual scale

10

Description
Determining the frequency of side effect ( nausea, dizziness, headache, diarrhea, vomiting, chilling fever) in vaginal misoprostol group
Timepoint
Each 3 hours
Method of measurement
Nausea, dizziness, headache, chilling, diarrhea based on patient’s word, Vomiting: observing expulsion of content with pressure through upper gastro intestinal system, Fever: detection body temprature with termometer

11

Description
Determining the frequency of side effect ( nausea, dizziness, headache, diarrhea, vomiting, chilling fever) in sublingual misoprostol group
Timepoint
Each 3 hours
Method of measurement
Nausea, dizziness, headache, chilling, diarrhea based on patient’s word, Vomiting: observing expulsion of content with pressure through upper gastro intestinal system, Fever: detection body temperature with termometer

12

Description
Comparing the frequency of side effect ( nausea, dizziness, headache, diarrhea, vomiting, chilling fever) in vaginal and Sublingual misoprostol group
Timepoint
Each 3 hours
Method of measurement
Nausea, dizziness, headache, chilling, diarrhea based on patient’s word, Vomiting: observing expulsion of content with pressure through upper gastro intestinal system, Fever: detection body temperature with termometer

13

Description
Determining the frequency of needing to analgesics in sublingual misoprostol group
Timepoint
Each 3 hours
Method of measurement
Measuring analgesics doses

14

Description
Determining the frequency of needing to analgesics in vaginal misoprostol group
Timepoint
Each 3 hours
Method of measurement
Measuring analgesics doses

15

Description
Comparing the frequency of needing to analgesics in vaginal and misoprostol group
Timepoint
Each 3 hours
Method of measurement
Measuring analgesics doses

16

Description
Determining the frequency of breast tenderness in sublingual misoprostol group
Timepoint
Each 3 hours
Method of measurement
Question about pain if positive then breast examination

17

Description
Determining the frequency of breast tenderness in vaginal misoprostol group
Timepoint
Each 3 hours
Method of measurement
Question about pain if positive then breast examination

18

Description
Comparing the frequency of breast tenderness in vaginal and sublingual misoprostol group
Timepoint
Each 3 hours
Method of measurement
Question about pain if positive then breast examination

19

Description
Determining the average doses of misoprostol using for pregnancy termination in sublingual misoprostol group
Timepoint
From using misoprostol to pregnancy termination
Method of measurement
Determining the average doses of sublingual misoprostol needed for pregnancy termination

20

Description
Determining the average doses of misoprostol using for pregnancy termination in vaginal misoprostol group
Timepoint
From using misoprostol to pregnancy termination
Method of measurement
Determining the average doses of vaginal misoprostol needed for pregnancy termination

21

Description
Comparing the average doses of misoprostol using for pregnancy termination in vaginal and sublingual misoprostol group
Timepoint
From using misoprostol to pregnancy termination
Method of measurement
Determining the average doses of vaginal and sublingual misoprostol needed for pregnancy termination

Intervention groups

1

Description
Vaginal misoprostol + sublingual placebo tablet. Tablet misoprostol is prescribe in the form vaginal, is a prostaglandin group, 200 micrograms. Interval of prescription is every 3 hours to 24 hours and then if pregnancy isnt terminated should be continued to 48 hours.
Category
Treatment - Drugs

2

Description
Sublingual misoprostol + vaginal placebo . Tablet misoprostol tablet is prescribe in the form sublingual , prostaglandin group, 200 microgram. Interval of prescription is every 3 hours to 24 hours and then if pregnancy isnt terminated should be continued to 48 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital, Guilan University of Medical Sciences
Full name of responsible person
Dr Forozan milani
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave.
City
Rasht
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, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Forozan Milani
Position
Obstetrics Gynecologist, Fellowship prenatalogy
Other areas of specialty/work
Street address
Reproduction Health Research Center, Al-Zahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
forozanmilani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Forozan Milani
Position
Obstetrics Gynecologist, fellowship prenatalogy
Other areas of specialty/work
Street address
Reproductive health Research Center, Al-Zahra Hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
forozanmilani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Seyede Maryam Mousavi Chahardeh
Position
B.S\Obstetrics
Other areas of specialty/work
Street address
Reproductive Health Research Center\Al-Zahra Hospital
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
h_fertility@gums.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
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