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Comparison the Effect of Isosorbide Mononitrate, Laminaria and Trans Cervical Catheter on cervical ripening and termination of term pregnancy

Protocol summary

Summary
The aim of this study is to investigate of the effects of Isosorbide mononitrate, laminaria and trans-cervical catheter on cervical ripening and terminating term pregnancy. Inclusion criteria included included the following: the Women with term pregnancy that are candidates for induction of labor, Bishop score is less than 4, Presentation of fetus is to be vertex and Nulliparous women. Exclusion criteria included the following: Having a spontaneous contraction and Rupture of membranes.The study population included of all nulliparous pregnant women with term pregnancy who will be referred for termination of pregnancy to the Kowsar hospital. Sample size would be 25 patients in each group. In Isosorbide mononitrate, 40 mg of this drug as Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third doses, if Bishop is less than 4 per examination will be repeated every 4 hours. Administration of oxytocin immediately after preparation of the cervix or no response to procedures will be performed after 24 hours. In the trans-cervical catheter group, a Foley catheter will be used. Catheter through the cervix will be inserted into the internal orifice of the cervix and balloon with 30 cc of air will be filled. In Laminaria group, first, the maternal vagina will be cleaned with Bethadine. After the speculum inserted, the anterior lip of the cervix will be taken with tenaculum and laminaria will be taken down depending on the size of the cervix so that its tip has been diced near the internal opening of the cervix. the time between the onset of amniotomy or oxytocin administration to active phase; duration of first stage of labor; duration of the second stage of labor; duration of the third stage of labor; maternal complications (overstimulation of the uterus, postpartum hemorrhage, genital tract lacerations, headaches, nausea, vomiting, and dizziness); mode of delivery; neonatal outcomes (Apgar score at first and fifth minutes, sex and birth weight, hospitalization of neonate in the Neonatal Intensive Care Unit) will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012616368N1
Registration date: 2014-02-22, 1392/12/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-02-22, 1392/12/03
Registrant information
Name
Maryam Iranipoor
Name of organization / entity
Qazvin University of Medical and Health Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6374
Email address
miranipoor@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Medicine school, Qazvin University of Medical Sciences and Health Services
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-02-28, 1392/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Isosorbide Mononitrate, Laminaria and Trans Cervical Catheter on cervical ripening and termination of term pregnancy
Public title
cervical ripening and termination of term pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women with term pregnancy that are candidates for induction of labor; Bishop score is less than 4; Presentation of fetus is to be vertex; Nulliparous women.Exclusion criteria: Having a spontaneous contraction; Rupture of membranes; Placenta previa.
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences and Health Services
Street address
Medicine School, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard
City
Qazvin
Postal code
Approval date
2013-09-04, 1392/06/13
Ethics committee reference number
28/20/7813

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
cervical ripening
Timepoint
During at the study (every 4 hours)
Method of measurement
Examination of the vagina

Secondary outcomes

1

Description
Duration of the third stage of labor (from complete expulsion of fetus to the exit of placenta)
Timepoint
During at the study
Method of measurement
Observation and examination

2

Description
Method of Delivery
Timepoint
During at the study
Method of measurement
Observation and examination

3

Description
Maternal complications (Over stimulation of the uterus, postpartum hemorrhage, genital tract lacerations, headaches, nausea, vomiting, and dizziness)
Timepoint
During at the study
Method of measurement
Observation and examination

4

Description
Duration of first stage of labor (including latent and active phases)
Timepoint
During at the study
Method of measurement
Observation and examination

5

Description
Duration of the second stage of labor (from full dilatation to expulsion of fetus)
Timepoint
During at the study
Method of measurement
Observation and examination

6

Description
Neonatal outcomes (Apgar score at first and fifth minutes, sex and birth weight, hospitalization of neonate in the Neonatal Intesive Care Uinte) will be measured
Timepoint
During at the study
Method of measurement
Observation and examination

Intervention groups

1

Description
In first group, Isosorbide Mononitrate, 40 mg of this drug as Tablets will insert to the mother's vagina in Posterior Fornix. The dose can be repeated up to 3 times every 4 hours. The second and third doses, if Bishop is less than 4 per examination will be repeated every 4 hours. Administration of oxytocin immediately after preparation of the cervix (Bishop more than 4) or no response to procedures will be performed after 24 hours.
Category
Treatment - Drugs

2

Description
In the second group, a Foley catheter will be used. Catheter through the cervix will be inserted into the internal orifice of the cervix and balloon with 30 cc of air will be filled.
Category
Treatment - Devices

3

Description
In third group, first, maternal vagina will be cleaned with Bethadine. After the speculum inserted, the anterior lip of the cervix will be taken with tenaculum and laminaria will be taken down depending on the size of the cervix so that its tip has been diced near the internal opening of the cervix.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Maryam Iranipoor
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Dr Saeid Asef Zadeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences and Health Services
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
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Maryam Iranipoor
Position
Resident of Obstetric and Gynecology
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1223 7267
Fax
Email
miranipoor@qums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Farideh Movahed
Position
Assistant professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Phone
00
Fax
Email
miranipoor@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Full name of responsible person
Maryam Iranipoor
Position
Resident of Obstetric and Gynecology
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences and Health Services, Shahid Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Phone
00
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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