Protocol summary
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Study aim
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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
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Design
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A double blind randomized controlled trial with three parallel arms
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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The Bishop score and duration of first stage of labor will be considered as main outcome variables.
General information
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Reason for update
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The start date of sampling at the time of trial registration was mistakenly recorded as 2020/6/21, which was one day before registration and showed the research retrospective, while the research was prospective and the actual sampling started 6 months later than study registration in 2020/12/4.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120718010324N56
Registration date:
2020-06-22, 1399/04/02
Registration timing:
prospective
Last update:
2023-03-11, 1401/12/20
Update count:
1
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Registration date
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2020-06-22, 1399/04/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2021-03-17, 1399/12/27
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Actual recruitment start date
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2020-12-04, 1399/09/14
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Actual recruitment end date
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2021-12-20, 1400/09/29
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Assessing the effect of cervical ripening baloon and evening primrose oil comparing with misoprostol on bishop score and duration of first stage of labor
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
90
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-26, 1399/03/06
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Ethics committee reference number
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IR.TBZMED.REC.1399.141
Health conditions studied
1
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Description of health condition studied
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Labor induction
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ICD-10 code
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O83.8
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ICD-10 code description
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Other specified assisted single delivery
Primary outcomes
1
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Description
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Bishop score
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Timepoint
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Before intervention and every 4 hours after intervention until 12 hours
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Method of measurement
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Bishop scoring scale
2
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Description
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Duration of first stage of labor
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Timepoint
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From beginning of induction until childbirth
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Method of measurement
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Partograph
Secondary outcomes
1
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Description
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Duration of second stage of labor
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Timepoint
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After full dilatation
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Method of measurement
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Partograph
2
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Description
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Duration of third stage of labor
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Timepoint
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After neonatal delivery until deliver the placenta
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Method of measurement
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Partograph
3
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Description
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Type of delivery (cesarean section rate)
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Timepoint
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After delivery
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Method of measurement
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Researcher's designed form
4
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Description
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First and fifth minute Apgar score
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Timepoint
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After delivery
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Method of measurement
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Baby profile sheet
5
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Description
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Use of oxytocin for labor induction
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Timepoint
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During labor
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Method of measurement
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Partograph and labor process improvement sheet
6
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Description
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Mean score of birth satisfaction
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Timepoint
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12- 24 hours after delivery
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Method of measurement
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Birth Satisfaction Scale- revised (BSS-R)
7
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Description
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Side effects
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Timepoint
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During labor and after delivery
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Method of measurement
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Researcher's designed form
Intervention groups
1
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Description
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Intervention group 1: vaginal capsule evening primrose oil 4000 mg
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Double balloon cervical ripening catheter
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Category
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Treatment - Devices
3
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Description
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Intervention group 3: vaginal tablet misoprostol 25 microgram
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The results of clinical study will be published as article
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When the data will become available and for how long
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Immediately after publishing the results
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Scientific using with citation to article
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From where data/document is obtainable
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mirghafourvandm@tbzmed.ac.ir
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What processes are involved for a request to access data/document
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Up to one week after communication by email
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Comments
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