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The effect of Isosorbide Mononitrate (vs. placebo) on induction success in pregnant women

Protocol summary

Summary
The objective of this study is to examine of induction success and maternal & fetal complications of Iso sorbide Mono Nitrate(IMN) on cervical ripening .The inclusion criteria: 1-single pregnancy, 2- cephalic presentation, 3- Bishop Score ≤6, 4-normal AFI>5, 5- regular FHR, 6- intact membrane, 7- gestational age ≥37 weeks. Exclusion criteria are: Uterine contraction (≥3 contraction 45’’ in 10 minutes) previous mymomectomy, history of headache, intolerance IMN, cardiopulmonary disease, vaso previa or placenta previa, cord prolepses, classic incision or previous myomectomy, irregular FHR, multiple pregnancy, macrosomia, polyhydramious, severe preeclampsia, maternal short stature. All candidates take an informed consent and assigned randomly into two groups (receiving 40 mg IMN or placebo). Outcomes are : interval between admission to Normal vaginal delivery, type of delivery(NVD-C/S), bleeding level, interval between admission and active phase, neonatal outcomes (APGAR score, NICU admission), maternal outcomes ( headache, palpitation), fetal outcome (tacysystole, hyperstimulation syndrome, hypersystole)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803311946N3
Registration date: 2010-12-08, 1389/09/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-12-08, 1389/09/17
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan university of medical sciences
Expected recruitment start date
2009-08-27, 1388/06/05
Expected recruitment end date
2011-08-27, 1390/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Isosorbide Mononitrate (vs. placebo) on induction success in pregnant women
Public title
The effect of Isosorbide Mononitrate on induction success
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: 1-single pregnancy, 2- cephalic presentation, 3- Bishop Score ≤6, 4-normal AFI>5, 5- regular FHR, 6- intact membrane, 7- gestational age ≥37 weeks. Exclusion criteria are: Uterine contraction (≥3 contraction 45’’ in 10 minutes) previous mymomectomy, history of headache, intolerance IMN, cardiopulmonary disease, vaso previa or placenta previa, cord prolepses, classic incision or previous myomectomy, irregular FHR, multiple pregnancy, macrosomia, polyhydramious, severe preeclampsia, maternal short stature.
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: 72
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
Vice chancellor for research, Guilan University of Medical Sciences
Street address
Opposite of Azodi Studium, Namjo street
City
Rasht
Postal code
Approval date
empty
Ethics committee reference number
3092

Health conditions studied

1

Description of health condition studied
Other assisted single delivery
ICD-10 code
O83
ICD-10 code description
Other assisted single delivery

Primary outcomes

1

Description
labor course
Timepoint
Hospitalization to delivery
Method of measurement
Based on Documented data

2

Description
delivery mode
Timepoint
Post partum
Method of measurement
Based on Documented data

3

Description
bleeding volume in labor and post partum
Timepoint
Control of labor course
Method of measurement
Based on Documented data

4

Description
hospitalization duration and active phase initiation
Timepoint
Control of labor course
Method of measurement
Based on Documented data

Secondary outcomes

1

Description
newborn apgar score
Timepoint
Immediately after delivery
Method of measurement
Based on documented data

2

Description
NICU requirement
Timepoint
Post partum
Method of measurement
Based on documented data

3

Description
the rate of maternal palpitation
Timepoint
During labor
Method of measurement
Based on documented data

4

Description
the occurance of maternal headache
Timepoint
Control during labor & delivery
Method of measurement
Based on documented data

5

Description
the ocurrance of tachysystol/hypersystol and hyperstimulated syndrome
Timepoint
FHR monitoring during labor
Method of measurement
Based on documented data

Intervention groups

1

Description
Isosorbide Mononitrate, 40mg, vaginal for the caces
Category
Treatment - Drugs

2

Description
Placebo for the control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital, Guilan university of medical sciences
Full name of responsible person
Street address
Alzahra hospital, Namjo street
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
Mandana Mansuor Ghanaie
Position
Assistant professor
Other areas of specialty/work
Street address
Reproduction Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanie@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mandana Mansur Ghanaie
Position
Assistant professor
Other areas of specialty/work
Street address
Reproduction Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 911 331 3240
Fax
Email
m_m_ghanaie@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Reproduction Health Reseach Center, Guilan University of Medical Sciences
Full name of responsible person
Seyede Fatemeh Dalil Hirati
Position
Bs in Midwifery
Other areas of specialty/work
Street address
Reproduction Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
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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