Prostaglandins are effective for ripening of cervix and induction of labor. Probably vaginal PH is an important factor in the effectiveness of vaginal prostaglandins. The aim of this study was to evaluate the effect of vaginal PH on the function of prostaglandin vaginal tablet in labor course. This was a clinical trial study on 147 pregnant primigravid women in age range of 16-35 years. Initial PH was measured during vaginal examination with Nitrazin paper and the Bishop score determined. All women received vaginal Dinoprostone inserted in posterior fornix of vagina for cervical ripening and the second dose was administered if the uterine contractions were inadequate. The reassessment of Bishop Score after 12 hours, duration of latent and active phase and also the duration of the second stage of labor was compared between two groups of the study (high or low vaginal PH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904091760N7
Registration date:2010-06-30, 1389/04/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-30, 1389/04/09
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2005-10-20, 1384/07/28
Expected recruitment end date
2006-10-20, 1385/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vaginal PH on efficacy of controlled- release Dinoprostone vaginal insert for cervical ripening/ labor induction.
Public title
Effect of vaginal PH on efficacy of controlled- release Dinoprostone vaginal insert for cervical ripening/ labor induction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with age 16-35 years, nulligravida, single tone pregnancy, cephalic presentation, Bishop Score equal or less than 5, no contraindication for vaginal delivery, uterine contractions did not start. Exclusion criteria: known allergy to prostaglandins, membrane rupture, fetal infection, history of previous surgery on the uterus and the previous induction of labor in recent pregnancy.
Age
From 16 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
147
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
4717641367
Approval date
2005-10-12, 1384/07/20
Ethics committee reference number
1015
Health conditions studied
1
Description of health condition studied
Labor Induction
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
cervix softening
Timepoint
After 12 hours of placing a vaginal suppository
Method of measurement
Bishop score
Secondary outcomes
1
Description
Duration of the stages of labor
Timepoint
Intervals between each stage (Latent phase, the active phase and second stage of labor)
Method of measurement
From time to start feeling regular contractions to dilatation 3-5 cm (Latent phase) / Dilatation from 3-5 cm to complete dilatation (active phase) / Since the complete withdrawal dilatation to fetus (Second stage of labor)
Intervention groups
1
Description
Vaginal tablets Dinoprostone (Containing 3 mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad Hospital
Full name of responsible person
Dr. Azita Ghanbarpoor Shiadeh
Street address
Yahyanejad Hospital
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Gangafroz Avenue
City
Babol
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 and Technology, Babol 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
Fatemehzahra Fertility & Reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com , zahra@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & Reproductive Health Reseach Center
Full name of responsible person
Dr. Zahra Basirat
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zahra_basirat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani steert
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)