The aim of this study is to compare the results of induction of vaginal misoprostol with Foley catheter in prolonged pregnancy with unripe cervix. 60 pregnant women with prolonged gestation (gestational age greater than 40 weeks) will be included in the study who are referred to the Sayyad Shirazi Hospital in Gorgan. By using of block randomization pregnant women will be allocated into two groups: Foley Catheter (30 patients) and Vaginal Misoprostol (30 patients). In the present study, blinding will not implement. The Foley Catheter will be exposed to direct ventral speculum. Cervix will be cleaned by antiseptic solution. The Foley catheter size 16 is inserted into the cervix, and filled with 30 ml of normal saline sterile balloon. Foley Catheter will be placed under soft pulling for up to 12 hours. In the second group, misoprostol 25 micrograms are used vaginally in the posterior foreskin for the patient and will be repeated every 4 hours to a maximum of 200 micrograms until reaching the appropriate dilatation of the cervix. Proper contraction is defined at least three contraction every ten minutes with suitable strength.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052710340N13
Registration date:2017-06-26, 1396/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan university of medical sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the results of induction of vaginal misoprostol with Foley catheter in prolonged pregnancy with unripe cervix
Public title
Comparison of vaginal Misoprostol versus Foley catheter for labor induction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Cephalic presentation; healthy amnion; Bishop score less than 6; inappropriate cervix; inappropriate uterine contractions; normal fetal heart rate.
Exclusion criteria was considered as : Pelvic dystocia; fetal weight more than 4 kg; incompatibility of fetal head with maternal pelvis ; placenta praevia; unexplained vaginal bleeding; the parity more than five; fetal anomaly; previous uterine scar; any situation that makes vaginal delivery impossible.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Approval date
2017-05-16, 1396/02/26
Ethics committee reference number
IR.GOUMS.REC.1396.23
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
O00-O99
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Labor induction
Timepoint
The first, second and third phase of delivery
Method of measurement
Stopwatch
Secondary outcomes
1
Description
Apgar
Timepoint
The first minute after the baby is born
Method of measurement
Apgar score
2
Description
Bleeding
Timepoint
After delivery
Method of measurement
The number of bleeding pads
Intervention groups
1
Description
Foley catheter 16
Category
Treatment - Other
2
Description
25 mcg tablets of misoprostol هد posterior vaginal fornix
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi hospital
Full name of responsible person
Ghazal Goli
Street address
Shahid Sayyad Shirazi hospital, Shahid Sayyad Shirazi Street, Gorgan City, Golestan Province
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Golestan University of Medical Sciences
Full name of responsible person
Mohsen Saeedi
Street address
4 Kilometer of Gorgan-Sari Road, Falsafi educational campus, Vice chancellor for research, Gorgan
City
Gorgan
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, Golestan 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
Golestan University of Medical Science
Full name of responsible person
Ghazal Goli
Position
Obstetricians
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-Sari Road, Falsafi educational campus, Vice chancellor of research, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
ghazalakjoon65@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Ghazal Goli
Position
Obstetricians
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-Sari Road, Falsafi educational campus, Vice chancellor of research, Gorgan
City
Gorgan
Postal code
Phone
00
Fax
Email
ghazalakjoon65@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golsestan University of Medical Sciences
Full name of responsible person
Mohamma Aryaie
Position
MSc in Epidemiology
Other areas of specialty/work
Street address
4 Kilometer of Gorgansari Road, Falsafi educational campus, Vice Chancellor of research, Gorgan
City
Gorgan
Postal code
Phone
00
Fax
Email
aryaie@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)