Labor induction with unfavorable cervix; Assessing the effect of cervical ripening balloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor
To determine the effect of cervical ripening baloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor
Design
A double blind randomized controlled trial with three parallel arms
Settings and conduct
In the labor ward of selected hospitals, If clients are eligible, an informed written consent will be obtained, then, Bishop's checklist will be completed .
Participants will be allocated to 3 groups by stratified randomized blocking method with block sizes of 3 and 6 with a 1: 1: 1 allocation ratio including 1: 25 µg of vaginal misoprostol, 2: 4000 mg vaginal capsule of evening primrose oil and 3: Cervical Ripening Baloon. For allocation concealment, the type of intervention will be written on piece of paper and placed inside the sequentially numbered envelopes.
Participants/Inclusion and exclusion criteria
The participants will be women with single and uncomplicated pregnancy, 40 weeks or more gestational age with indications of labor induction, cephalic presentation and Bishop's score less than 4.
Intervention groups
Intervention group 1: 25 micrograms vaginal misoprostol; Intervention group 2: 4000 miligrams vaginal cap evening primrose oil and Intervention group 3: Double balloon Ripping catheter
Main outcome variables
The Bishop score and duration of first stage of labor will be considered as main outcome variables.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N56
Registration date:2020-06-22, 1399/04/02
Registration timing:registered_while_recruiting
Last update:2020-06-22, 1399/04/02
Update count:1
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-03-17, 1399/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Labor induction with unfavorable cervix; Assessing the effect of cervical ripening balloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor
Public title
Assessing the effect of cervical ripening baloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age≥ 40 weeks
Vertex presentation
Parity ≤ 4
Single pregnancy
Lack of vaginal delivery contraindication
Uncomplicated pregnancy
Bishop score less than 4
Favorable non stress test in admission
Lack of effective uterine contractions (less than three contractions in 30 minutes)
Intact amniotic sac
Exclusion criteria:
Amniotic fluid volume Disorders
Intra Uterine Growth Retardation
Fetal macrosomia
Any contraindication for evening primrose oil use such as history of seizures in the mother or use of anticonvulsant drugs
Contraindication for labor induction
High risk pregnancy
Existence of chronic or systemic disease such as diabetes and hypertension
Existence of scar on the uterus
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to 3 groups by stratified randomized blocking method (stratification will be based on parity, primiparous in one strata and parity 2 - 4 in another strata) with block sizes of 3 and 6 with a 1: 1: 1 ratio as follows:
Group 1: 25 µg of vaginal misoprostol, Group 2: 4000 mg Vaginal capsule of evening primrose oil (EPO) and Group 3: Cervical Ripening Baloon.
for Allocation Concealment, the type of intervention will be written on piece of paper and placed inside the serial numbered envelopes. After obtaining informed consent, the relevant envelope will be opened and the intervention will be performed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the drugs, two envelopes with the same content will be prepared for each participant, which will contain 4 capsules (EPO or Placebo capsules) and one tablet (Misoprostol or Placebo) and will be packaged in the same way. Envelopes will be coded by another person. About cervical Ripening Baloon, there is no possible for blinding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
IR.TBZMED.REC.1399.141
Health conditions studied
1
Description of health condition studied
Labor induction
ICD-10 code
O83.8
ICD-10 code description
Other specified assisted single delivery
Primary outcomes
1
Description
Bishop score
Timepoint
Before intervention and every 4 hours after intervention until 12 hours
Method of measurement
Bishop scoring scale
2
Description
Duration of first stage of labor
Timepoint
From beginning of induction until childbirth
Method of measurement
Partograph
Secondary outcomes
1
Description
Duration of second stage of labor
Timepoint
After full dilatation
Method of measurement
Partograph
2
Description
Duration of third stage of labor
Timepoint
After neonatal delivery until deliver the placenta
Method of measurement
Partograph
3
Description
Type of delivery (cesarean section rate)
Timepoint
After delivery
Method of measurement
Researcher's designed form
4
Description
First and fifth minute Apgar score
Timepoint
After delivery
Method of measurement
Baby profile sheet
5
Description
Use of oxytocin for labor induction
Timepoint
During labor
Method of measurement
Partograph and labor process improvement sheet
6
Description
Mean score of birth satisfaction
Timepoint
12- 24 hours after delivery
Method of measurement
Birth Satisfaction Scale- revised (BSS-R)
7
Description
Side effects
Timepoint
During labor and after delivery
Method of measurement
Researcher's designed form
Intervention groups
1
Description
Intervention group 1: vaginal capsule evening primrose oil 4000 mg
Category
Treatment - Drugs
2
Description
Intervention group 2: Double balloon cervical ripening catheter
Category
Treatment - Devices
3
Description
Intervention group 3: vaginal tablet misoprostol 25 microgram
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Shahla Hemmatzadeh
Street address
Alzahra Hospital, Artesh street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3541 2101
Email
shahla_obs@yahoo.com
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Shahla Hemmatzadeh
Street address
Taleghani Hospital, Rah Ahan Square
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4425
Email
shahla_obs@yahoo.com
3
Recruitment center
Name of recruitment center
29 Bahman Hospital
Full name of responsible person
Shahla Hemmatzadeh
Street address
29 Bahman boulevard
City
Tabriz
Province
East Azarbaijan
Postal code
5166617894
Phone
+98 41 3330 8000
Email
shahla_obs@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
mirghafourvandm@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shahla Hemmatzadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
shahla_obs@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document