Objective of the study: to evaluate the safety and effectiveness of 2mg dinoprostone vaginal gel when used in real life for the induction of labor in pregnant women.Inclusion Criteria: All pregnant women age above 18 years; scheduled for induction of labor with 2mg dinoprostone vaginal gel; bishop less then or equal to 4. Exclusion criteria: Bishop greater then 4. Study population: pregnant women. Sample size: 45 subjects. Intervation: Dinoprostone 2mg vaginal gel. Main outcomes measures: bishop score & mode of delivery were recorded to evaluate the treatment success. Secondary outcomes includes maternal, fetal and neonatal adverse events.
General information
Acronym
None
IRCT registration information
IRCT registration number:IRCT201502187974N6
Registration date:2015-03-14, 1393/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-14, 1393/12/23
Registrant information
Name
Ghousia Saba
Name of organization / entity
Pharma Professional Services
Country
Pakistan
Phone
(92-21) 36352328
Email address
ghousia@phaps.com
Recruitment status
Recruitment complete
Funding source
Pharmaceutical Company
Expected recruitment start date
2014-08-26, 1393/06/04
Expected recruitment end date
2014-10-10, 1393/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study for the safety and effectiveness of a commercial product of 2 mg dinoprostone vaginal gel in pregnant women.
Public title
Safety and effectiveness of dinoprostone vaginal gel in pregnant women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women; scheduled for labor induction with 2mg Dinoprostone vaginal gel; bishop score less than or equal to 4.
Exclusion criteria: Bishop score greater then 4.
Age
From 18 years old to 40 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Single arm, open label study
Secondary Ids
1
Registry name
WHO
Secondary trial Id
U1111-1167-6462
Registration date
2015-02-25, 1393/12/06
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of services institute of medical sciences
Street address
Ghus-ul-azam (jail road), services institute of medical sciences, services hospital
City
Lahore
Postal code
Approval date
2014-07-16, 1393/04/25
Ethics committee reference number
IRB/2014/80/SIMS
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
XV
ICD-10 code description
The codes included in this chapter are to be used for conditions related to or aggravated by the pregnancy, childbirth or by the puerperium (maternal causes or obstetric causes)
Primary outcomes
1
Description
increase of 3 in bishop score
Timepoint
six hours and 12 hours after dosing
Method of measurement
Bishop scoring method
2
Description
Attainment of bishop score of 6 or more
Timepoint
six and 12 hours after dosing
Method of measurement
Bishop scoring method
3
Description
vaginal delivery occurring within 12 hours of dosing
Timepoint
occurring within 12 hours of dosing
Method of measurement
subject monitoring
Secondary outcomes
1
Description
Maternal adverse events
Timepoint
from dosing to delivery
Method of measurement
Patient monitoring
2
Description
Neonatal adverse events
Timepoint
just after birth at 1 & 5 minutes
Method of measurement
APGAR score
3
Description
Fetal Adverse events
Timepoint
two hours after dosing, at six & 12 hours after dosing (till baby is not delivered)
Method of measurement
by measuring CTG
Intervention groups
1
Description
Dinoprostone 2mg vaginal gel (Glandin E2) inserted high into posterior fornix. dose repeated (if required and prescribed by doctor) after six hours of first dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Services hospital
Full name of responsible person
Prof. Dr. Rubina Sohail
Street address
Ghus-ul-azam (Jail road),
City
Lahore
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nabiqasim Industries (Pvt) Ltd.
Full name of responsible person
Salman Rahim
Street address
510, 5th floor, commerce center, Hasrat Mohani Road
City
Karachi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nabiqasim Industries (Pvt) Ltd.
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
Nabiqasim Industries (Pvt) Ltd.
Full name of responsible person
Salman Rahim
Position
Assistant Manager Regulatory Affairs
Other areas of specialty/work
Street address
510, 5th floor, commerce center, Hasrat Mohani Road
City
Karachi
Province
Sindh
Postal code
74200
Phone
009221 32636313
Fax
Email
salman.rahim@nabiqasim.com
Web page address
www.nabiqasim.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Services Hospiatl
Full name of responsible person
Prof. Dr. Rubina Sohail
Position
Professor Gynae unit II
Other areas of specialty/work
Street address
Ghus-ul-azam (jail road)
City
Lahore
Province
Punjab
Postal code
Phone
009242
Fax
Email
rubina95@gmail.com
Web page address
www.sims.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Pharma Professional Services
Full name of responsible person
Prof.Dr. Tasneem Ahmad
Position
Chief Investigator
Other areas of specialty/work
Street address
A-93, Ettawah Society, scheme 33
City
Karachi
Province
Sindh
Postal code
75343
Phone
00922136352328
Fax
Email
dr.tasneem@phaps.com
Web page address
www.phaps.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)