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Comparison of Misoprostol plus Isosorbide Mono Nitrate and Misoprostol plus placebo at the end of second trimester pregnancy.

Protocol summary

Study aim
The aim of this study is to compare Misoprostol, Isosorbide Mono Nitrate and Misoprostol, Placebo at the end of the second trimester of pregnancy.
Design
This study is a prospective, single-blind clinical trial on singleton pregnant women, with gestational age 22-13 weeks, undergoing termination of pregnancy. 54 patients divided into two groups and intervention and placebo ,A code was allocated to each one of them
Settings and conduct
The location of the study is Imam Reza Hospital in Kermanshah. After describing the conditions of the plan for patients, If patients complete Informed consent. They are divided into two intervention groups (Misoprostol + Isosorbide Mononitrate) and the Placebo group (Misoprostol + Placebo)
Participants/Inclusion and exclusion criteria
Inclusion criteria include nulliparous and multiparous women to parity 5. Exclusion criteria include multifetal pregnancy, contra indication of Isosorbide mono nitrate (IMN) and contra indication of misoprostol .
Intervention groups
Patients(54 cases) were randomly divided into two groups: A (Misoprostol + Placebo) and B (Misoprostol + Isosorbide Mono Nitrate).In group A, vitamin B6, 40 mg (Jalinoos Company), is inserted into the vagina in posterior fornix, and 4 hours later, Misoprostol 400mcg, equivalent to two 200mcg tablets (aria Company) stained with saline will be insertedIn group B Isosorbide Mononitrate 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, Misoprostol 400mcg stained with saline will be inserted. In the event of treatment failure (failure to pass the gestational product within 24 hours), the second course of treatment will be done.
Main outcome variables
Failure to pass the gestational product within 24 hours, abdominal pain, spotting, nausea, vomiting, diarrhea, headache, dizziness, palpitation and fever

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100525004025N5
Registration date: 2017-12-15, 1396/09/24
Registration timing: retrospective

Last update: 2017-12-15, 1396/09/24
Update count: 0
Registration date
2017-12-15, 1396/09/24
Registrant information
Name
Anisodowleh Nankali
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
anankali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Misoprostol plus Isosorbide Mono Nitrate and Misoprostol plus placebo at the end of second trimester pregnancy.
Public title
Effect of misoprostol plus isosorbide mononitrate and misoprostol plus placebo in induction of second trimester abortion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 22-13 weeks can be a condition for entering the study. nulliparous Can be a condition for entering the study. Multiparous to parity 5 Can be a condition for entering the study. singleton pregnancy can be a condition for entering the study.
Exclusion criteria:
Women with contra indication of misoprostol (active Cardiac-pulmonary disease, Placenta Previa, history of 2 or more previous cesarean section, or history of major uterine surgeries such as myomectomy and uterine reconstruction surgery)Conditions for not admitting to study. Women with contraindication of Isosorbide mono nitrate (IMN) (sensitivity to nitrates, hypotension, hypovolemia, heart disease, significant anemia Hb below 7 gr / dl and closed angle glaucoma )Conditions for not admitting to study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
If patients complete Informed consent, they are divided into two intervention groups (Misoprostol +Isosorbide Mononitrate) and the placebo group (Misoprostol + Placebo) . Patients do not know the type of drug they receive
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah, Nursing Blvd, Sorkhe Lyzheh, Imam Reza Teaching Hospital,
City
Kermanshah
Province
Kermanshah
Postal code
15333-67144
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
kums.rec.1395.532

Health conditions studied

1

Description of health condition studied
Termination of pregnancy
ICD-10 code
XV
ICD-10 code description
Pregnancy with abortive outcome

Primary outcomes

1

Description
The abortion rate is 12 hours
Timepoint
12 hours later intervention
Method of measurement
View the disposal of pregnancy products

2

Description
The abortion rate is 24-12 hours
Timepoint
Abortion after 12 hours to 24 hours of intervention
Method of measurement
View the disposal of pregnancy products

3

Description
Abortion rate after 24 hours
Timepoint
In the 24th hour of the intervention
Method of measurement
View the disposal of pregnancy products

Secondary outcomes

1

Description
Nausea
Timepoint
Every 4 hours after intervention   until the Disposal of pregnancy products
Method of measurement
See Symptoms of the patient

2

Description
vomiting
Timepoint
Every 4 hours after intervention until the disposal of pregnancy products
Method of measurement
See Symptoms of the patient

3

Description
Diarrhea
Timepoint
Every 4 hours after intervention until the disposal of pregnancy products
Method of measurement
See Symptoms of the patient

4

Description
Fever and chills
Timepoint
Every 4 hours after intervention until the disposal of pregnancy products
Method of measurement
See Symptoms of the patient

5

Description
Headache
Timepoint
Every 4 hours after intervention until the disposal of pregnancy products
Method of measurement
See Symptoms of the patient

6

Description
heart beat
Timepoint
Every 4 hours after intervention until the disposal of pregnancy products
Method of measurement
See Symptoms of the patient

7

Description
Confusion
Timepoint
Every 4 hours after intervention until the disposal of pregnancy products
Method of measurement
See Symptoms of the patient

Intervention groups

1

Description
In group A(control), vitamin B6, 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, misoprostol 400mcg, equivalent to two 200mcg tablets stained with saline will be inserted .
Category
Placebo

2

Description
In group B(case) Isosorbide Mononitrate 40 mg, is inserted into the vagina in posterior fornix, and 4 hours later, Misoprostol 400mcg stained with saline will be inserted.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Teaching Hospital
Full name of responsible person
Dr. Mona Khorami
Street address
Kermanshah, Nursing Blvd, Sorkhe Lyzheh, Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Email
anis_nankali@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy Kermanshah University of Medical Sciences
Full name of responsible person
Dr .Farid Najafi
Street address
Kermanshah, Shahid Beheshti Blvd., Building No. 2,Vice Chancellor for Research and Technology
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Email
anis_nankali@yahoo.com
Grant name
Grant code / Reference number
10421600
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mona Khorami
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences Sorkhe Lyzheh- Imam Reza Teaching hospital-Office of Women's Education
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Fax
Email
saeedkhorami87@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Dr Anisodowleh Nankali
Position
Associate Professor   Kermanshah University of Medical Sciences,
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Kermanshah University of Medical Science- Sorkhe Lyzheh- Imam Reza Teaching Hospital-Office Of Women's Education
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83342763018
Fax
Email
anankali@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
kermanshah University and Medical Sciences
Full name of responsible person
Dr. Mona Khorami
Position
Resident of Obstetrices and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences - Sorkhe Lyzheh- Imam Reza Hospital-maternity research center
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Fax
Email
saeedkhorami87@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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