Comparison extra amniotic salin infusion and vaginal isoniazide for cervical ripening before induction and labour duration in term and post term pregnancy
The aim of this study is to assess the efficacy of intravaginal isoniazide compare with extra amniotic saline infusion for cervical ripening at term and post term. In this randomized single-blind controlled trial 150 pregnant women who will schedule for labor induction, with Bishop Score <5 is recruited. The efficacy of medications is evaluated by preterminated primary and secondary outcome variable for cervical ripening and induction and delivery. Inclusion criteria are vertex presentation and single tone pregnancy. Exclusion criteria are intra uterine growth restricting, preeclampsia and rupture of membrane.
General information
Acronym
EASI: Extra amniotic salin infusion.
IRCT registration information
IRCT registration number:IRCT2015040721506N2
Registration date:2015-04-28, 1394/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-28, 1394/02/08
Registrant information
Name
Ladan Haghighi
Name of organization / entity
Iran Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 64345
Email address
haghighi.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Scienses
Expected recruitment start date
2015-01-02, 1393/10/12
Expected recruitment end date
2015-07-20, 1394/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison extra amniotic salin infusion and vaginal isoniazide for cervical ripening before induction and labour duration in term and post term pregnancy
Public title
Comparison extra amniotic salin infusion and vaginal isoniazide for cervical ripening before induction and labour duration in term and post term pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- single tone pregnancy 2- bishop score<5.
Exclusion criteria: 1-macrosomia EFW> 5 Kg. 2- not reassuring NST. 3- PROM 4-AFI<5 Cm. 5- history of kidney and liver diseases. 6-history of Cesarian section. 7- low lying placenta. 8- any contraindication of isoniazide such as vomiting, nausea, visual defect, vertigo. 9- no cephalic presentation. 10- unexplained vaginal bleeding. 11- labor phase. 12- organic disease. 12- grand multiparity
Age
From 17 years old to 43 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, near Milad tower, Hemmat highway
City
Tehran
Postal code
Approval date
2015-02-14, 1393/11/25
Ethics committee reference number
93/د/105/5534
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
Z34
ICD-10 code description
Normal pregnancy
Primary outcomes
1
Description
Bishap score
Timepoint
Before intervetion and before induction
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Interval intervention until active phase
Timepoint
Start of intervention till delivery
Method of measurement
Minutes
2
Description
Interval between intervention till labour
Timepoint
Start of intervention till delivery
Method of measurement
Minutes
3
Description
time intrval between intervetion till indoction of labour
Timepoint
start of intervention
Method of measurement
minute
4
Description
Compliation vomating and nausia and icter and vertigo
Timepoint
Start of intervention till delivery
Method of measurement
Examination and question
Intervention groups
1
Description
In another group folly catheter is applied in cervix extra amniotic which bublle filled with 40 mili litre strilewater
Category
Other
2
Description
In one group vaginal isoniyazide is applied 900 mg tablets every 4 hours for 3 doses.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi hospital
Full name of responsible person
Dr. Samira Saadatjoo
Street address
Shahid Akbar Abadi hospital, Molavi street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mrs. Irani
Street address
Fifth floor, Research departman, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samira Saadatjoo
Position
MD, obsetrics resident
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Molavi street
City
Tehran
Postal code
Phone
+98 21 5553 2277
Fax
Email
saadat6359@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Universiry of Medical Sciences
Full name of responsible person
Ladan Haghighi
Position
Professor
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Molavi street
City
Tehran
Postal code
Phone
+98 21 8814 9838
Fax
Email
saadat6359@gmail.com; dr.ladanhaghighi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Saadatjoo
Position
MD, obsetrics resident
Other areas of specialty/work
Street address
Shahid Akbar Abadi hospital, Molavi street
City
Tehran
Postal code
Phone
+98 21 5553 2277
Fax
Email
saadat6359@gmail.com; dr.ladanhaghighi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)