Objective: The aim of this study is the comparison of intravaginal misoprostol, seaweed Laminaria and Foley catheter for cervical ripening and induction of labor in term pregnant women.
Design
Study design: Randomized double-blind clinical trial. Randomization will be done by the use of computer-generated random numbers.
Settings and conduct
Among term pregnant women with unripe cervix referred to Shabihkhani Clinic affiliated to Kashan University of Medical Sciences, 195 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged 18 to 45 years with unripe cervix, Gestational age ≥ 37, Amniotic Fluid Index ≥ 5, and Bishop Score < 5. Exclusion criteria: Pregnant women with labor pain, patients develop chorioamnionitis, fever, and hemorrhage.
Intervention groups
Patients who enroll in the study will be randomized into one of 3 study arms: Intravaginal misoprostol (n=65), seaweed Laminaria (n=65), and Foley catheter (n=65) for cervical ripening and induction of labor in term pregnant women.
Main outcome variables
Outcomes: Bishop Scores and cervical dilatation (primary outcomes) and induction time to active phase of labor, induction time to delivery time, cesarean frequency rate and intrapartum complications (secondary outcomes) will be quantified.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N39
Registration date:2018-10-21, 1397/07/29
Registration timing:retrospective
Last update:2018-10-21, 1397/07/29
Update count:0
Registration date
2018-10-21, 1397/07/29
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-29, 1397/03/08
Expected recruitment end date
2018-06-12, 1397/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravaginal misoprostol, seaweed Laminaria and Foley catheter for cervical ripening and induction of labor in term pregnant women
Public title
Comparison of intravaginal misoprostol, seaweed Laminaria and Foley catheter in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18 to 45 years with with unripe cervix
Gestational age ≥ 37
ََAmniotic Fluid Index ≥ 5
Bishop Score < 5
Exclusion criteria:
Pregnant women with labor pain
patients develop chorioamnionitis
fever
hemorrhage
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
195
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to age and other characteristics. Then, participants in each block will be randomly allocated into three intervention groups. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shabihkhani clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants into three groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.012
Health conditions studied
1
Description of health condition studied
Pregnant state
ICD-10 code
Z33
ICD-10 code description
Pregnant state
Primary outcomes
1
Description
Bishop Scores
Timepoint
six hours after the intervention
Method of measurement
Physical Examination
2
Description
cervical dilatation
Timepoint
six hours after the intervention
Method of measurement
Physical Examination
Secondary outcomes
1
Description
induction time to active phase of labor
Timepoint
after the intervention
Method of measurement
time measrement (hours)
2
Description
induction time to delivery time
Timepoint
after the intervention
Method of measurement
time measrement (hours)
3
Description
cesarean frequency rate
Timepoint
after the intervention
Method of measurement
checklist
4
Description
intrapartum complications (Placental Abruption, atonia, and etc)
Timepoint
after the intervention
Method of measurement
physical examination
Intervention groups
1
Description
Intervention group: Intravaginal misoprostol 25 mcg (Cytotec, searle, England) will be put in posterior Culdusac for cervical ripening (n=65)
Category
Treatment - Drugs
2
Description
Intervention group: seaweed Laminaria (Dilateria™, Tasnimbehboud company, Tehran, Iran) will be used for cervical ripening (n=65)
Category
Treatment - Drugs
3
Description
Intervention group: An intra-cervical Foley catheter (size of 22) will be put intra-cervix with sterile condition for cervical ripening and it will be fixed by 15 ml liquid (n=65)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihkhani Clinic
Full name of responsible person
Dr. Zohreh Tabassi
Street address
Shahid Beheshti Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
tabasi_z@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabassi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
tabasi_z@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabassi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
tabasi_z@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabassi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Beheshti Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
tabasi_z@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available