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The Effect of Vaginal Administration of Isosorbide Mononitrate on Cervical Ripening and Iduction Of Labor In Postterm Pregnancy

Protocol summary

Summary
This clinical trial is double blind, randomized with Placebo-controlled groups that will be carried out in Sina hospital in Ahvaz. Participants will be women with postdate pregnancy who require labor induction. Eligible women are interviewed following a visit by gynecologist and study goals are explained completely for them. Written agreement will be obtained and their demographic characteristics will be recorded by the researcher. After physical examination, cervix bishop score is determined and then 40 mg Isosorbite mononitrate or placebo prepared by pharmacist will be administered into the posterior vaginal fornix. Mothers will be under supervision for 2 hours before they are allowed to go home.The time of next visit is set and they are advised to avoid taking any drug or intercourse. They will be asked to return immediately to hospital if there are some painful contractions, premature rupture of membrane, vaginal bleeding or bloody show. Nevertheless all subjects should return after 12 hours and will all of them will be admitted. The second dose of drug or placebo is administrated and after 24 hours from the first visit, the bishop score of cervix is determined and classic induction with oxytocin will begin if they are not in active labor. Bishop score changes, duration of delivery induction, time from start of oxytocin to active phase, duration of active phase, second and third stage of labor, the amount of consumed oxytocin, mode of delivery, any kind of maternal and fetal outcome will be registered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011305234N1
Registration date: 2010-12-29, 1389/10/08
Registration timing: na

Last update:
Update count: 0
Registration date
2010-12-29, 1389/10/08
Registrant information
Name
Hamideh Yazdizadeh
Name of organization / entity
Faculty of nursery and midwifery-Ahvaz jondishapur unversity of medical science
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 1380
Email address
yazdizadeh_h@ajums.ac.ir
Recruitment status
Not enough for processing
Funding source
Research Deputy, Ahvaz Jondishapur university of medical science
Expected recruitment start date
2010-12-06, 1389/09/15
Expected recruitment end date
2010-08-22, 1389/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vaginal Administration of Isosorbide Mononitrate on Cervical Ripening and Iduction Of Labor In Postterm Pregnancy
Public title
Cervical ripening before induction of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-35, nullipara, Bishop sore equal or low of 5, To have Reliable LMP or sonography in first trimester, To have BMI 19.6-26 in first trimester, Cephalic presentation, Fetal Weigth=2500-4000, single fetus, To have NST and biophysical profil in last 48 hours, Gestational age: 40-42 w Exclusion criteria: Congenital abnormalitywith sono in the second trimester, preclampsia, Headache, post C/S, Active genital herpes, Addict to alcohol, polyhydroamnios, placenta previa or doubt to placenta abruption, previous breath or heard disease, to have any conterindication for induction of labor, BPs<90
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ahvaz Jondishapur university of medial science
Street address
Golestan Hiway
City
Ahvaz
Postal code
Approval date
2010-11-28, 1389/09/07
Ethics committee reference number
ETH-O16

Health conditions studied

1

Description of health condition studied
Cervical ripening and induction of labor
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cervical ripening
Timepoint
24 hours
Method of measurement
measurement of cervix bishop score

Secondary outcomes

empty

Intervention groups

1

Description
vaginal administration oral tablet isosorbite mononitrate 20 mg, two tablets per 12 hours before start of induction of labor with oxytocin in interventional group
Category
Treatment - Drugs

2

Description
In plasebo group: to give plasebo tablet made of caco3, Odisel, Mg estearate 1% that will be made by Ahvaz Faculty of pharmacy, 24 hours before start of induction of labor with oxytocin
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
sina hospital
Full name of responsible person
Street address
City
AHVAZ

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy, Ahvaz Jondishapur university of medical science
Full name of responsible person
Dr.Mostafa Feghhi
Street address
Research Deputy,Ahvaz Jondishapur university of Medical Science
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy, Ahvaz Jondishapur 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
Ahvaz Jondishapur university of medical science - Faculty of nursing and midwifery
Full name of responsible person
Hamideh Yazdizadeh
Position
Mastering of Science student in Midwifery
Other areas of specialty/work
Street address
Ahvaz Jondishapur university of medical science- Faculty of Nersery and Midwifery
City
Ahvaz
Postal code
Phone
+98 61 1373 8333
Fax
Email
yazdizadeh_h@ajums.ac.ir; yazdizadeh_mid@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jondishapur university of medical science- faculty of nursing and midwifery
Full name of responsible person
Dr. Parvin Abedi
Position
PhD in Society Nutrition
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery-Ahvaz Gondishapur university of medical science
City
Ahvaz
Postal code
Phone
+98 61 1373 8331
Fax
Email
parvinabedi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapur University of Medical Science- Faculty of Nersing and Midwifery
Full name of responsible person
Hamideh Yazdizadeh
Position
Mastering of Science student in Midwifery
Other areas of specialty/work
Street address
Golestan Highwey
City
Ahvaz
Postal code
Phone
Fax
Email
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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