Protocol summary

Summary
Purpose: Comparison of vaginal Isosorbaid mononitrat and vaginal estradiol and placebo effect on cervix ripening in post term pregnancy Design study: a randomized, triple blind, placebo-controlled The methods used included: (A): Key inclusion criteria: singleton pregnancy; cephalic presentation; intact membranes; BS less than 6; the result of normal fetal health monitoring; lack of uterine contractions; the absence of systemic problems; age 15 - 35 Main exclusion criteria: women with preeclampsia; history of previous cesarean; active genital herpes; poly Hydramnious; placenta previa or placental abruption risk; membrane rupture; history of Cardiac or respiratory disease; the presence of any contra indication for labor induction; systolic blood pressure less than 90 mmHg Sample size: 99 (B) Interventions in the study: From all of mothers, we will obtain a NST, and then patients will be divided into three groups according to randomized block plan. At the first group, vaginal estradiol 25 micro gram, at the second group, vaginal isosorbide mononitrate 20 mg, and at the third group, placebo placed in the posterior fornix and 12 hours after hospitalized, If BS is less than 6, previous dose is repeated again. Cervical examination is done every 2 hours. (C) The intervention time: At arrival, and 12 hours later. (D) The primary outcome or consequences of the study: to improve the cervical Bishop score, better response to induction of labor, cesarean section rate reduction

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015053122507N1
Registration date: 2015-08-21, 1394/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-21, 1394/05/30
Registrant information
Name
Nushin Chamheidar
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 2100
Email address
n.chamheidar@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-06-06, 1394/03/16
Expected recruitment end date
2016-02-05, 1394/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vaginal Isosorbaid mononitrat and vaginal estradiol and placebo effect on cervix ripening in post term pregnancy
Public title
preparation for delivery in late pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy; cephalic presentation; intact membranes; BS less than 6; the result of normal fetal health monitoring; lack of uterine contractions; the absence of systemic problems in the history; clinical examination; age 15 to 35 Exclusion criteria: women with preeclampsia; history of previous cesarean; active genital herpes; poly Hydramnious; placenta previa or placental abruption risk; membrane rupture; history of Cardiac or respiratory disease; the presence of any contra indication for labor induction; systolic blood pressure less than 90 mmHg
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: 99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil university of medical sciences, Pardis Office Complex, end of University Avenue, Janbazan Square, Ardabil
City
ardabil
Postal code
5618985991
Approval date
2015-02-16, 1393/11/27
Ethics committee reference number
Arums.Rec.93.63

Health conditions studied

1

Description of health condition studied
vaginal Isosorbaid mononitrat and vaginal estradiol and Placebo effect on cervix ripening
ICD-10 code
P08
ICD-10 code description
Disorders related to long gestation and high birth weight

Primary outcomes

1

Description
bishop score (cervix ripening)
Timepoint
at the visit, 12 hours and 24 hours later.
Method of measurement
Vaginal examination (According to Williams reference table to determine the Bishop score)

Secondary outcomes

1

Description
From active phase to full dilatation
Timepoint
During the study
Method of measurement
Observation and examination

2

Description
From full dilatation to delivery
Timepoint
During the study
Method of measurement
Observation and examination

3

Description
From Induction to active phase
Timepoint
During the study
Method of measurement
Observation and examination

4

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

5

Description
Maternal side effects (headache, nausea, vomiting, and dizziness)
Timepoint
During the study
Method of measurement
Observation and examination

6

Description
The consequences of neonatal (first and fifth minute Apgar score, gender and birth weight, infant hospitalized in the Intensive Care Unit, Meconium defecation)
Timepoint
During the study
Method of measurement
Observation and examination

Intervention groups

1

Description
From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the vaginal isosorbide mononitrate group, 1 tablet 20 mg isosorbide mononitrate placed in the posterior fornix (outpatients) and 12 hours after hospitalized, BS again determined. If less than 6 previous dose is repeated again. Cervical examinations conducted by the investigator every 2 hours.
Category
Treatment - Drugs

2

Description
From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the vaginal estradiol group, 1 tablet 25 micro gram placed in the posterior fornix (outpatients) and 12 hours after hospitalized, BS again determined. If less than 6 previous dose is repeated again. Cervical examinations conducted by the investigator every 2 hours.
Category
Treatment - Drugs

3

Description
From all of mothers, we will obtain a NST, After ensuring fetal heart rate pattern, patients randomized block design are divided into three groups. At the Placebo group, 1 Placebo tablet placed in the posterior fornix (outpatients) and 12 hours after hospitalized, BS again determined. If less than 6 previous dose is repeated again. Cervical examinations conducted by the investigator every 2 hours.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Nushin Chamheidar
Street address
Alavi Hospital, sport squre, Ardabil
City
Aedabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy Director of Research and Technology of Ardabil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardabil university of medical sciences, Pardis Office Complex, end of University Avenue, Janbazan Square, Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Director of Research and Technology of Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Nushin Chamheidar
Position
obstetric and gynecology resident
Other areas of specialty/work
Street address
Alavi Hospital, Varzesh squre, Ardabil
City
Ardabil
Postal code
5613974156
Phone
+98 45 3326 1714
Fax
+98 45 3323 7821
Email
nushin.chamheidar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Giti Rahimi
Position
Assistant Professor
Other areas of specialty/work
Street address
Alavi Hospital, Varzesh squre, Ardabil
City
Ardabil
Postal code
5613974156
Phone
+98 45 3325 2502
Fax
+98 45 3323 7821
Email
nushin.chamheidar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Nushin Chamheidar
Position
obstetric and gynecology resident
Other areas of specialty/work
Street address
Alavi Hospital, Varzesh squre, Ardabil
City
Ardabil
Postal code
5613974156
Phone
+98 45 3326 1714
Fax
+98 45 3323 7821
Email
nushin.chamheidar@gmail.com
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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