- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03001661
An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt (SOLVE)
A Randomised Controlled Trial of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt: the SOLVE Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective, Phase III, UK, Open, Multicentre, Superiority, Randomised Controlled Trial of a CE marked medical device and an Investigational Medicinal Product (CTIMP).
Potentially eligible patients will be identified by their obstetrician or midwife, based on the need for induction of labour. Once the decision to induce labour is made, women will be approached to participate in the trial and will be given a patient information leaflet (PIL) enclosed in the induction admission letter. Patients wishing to enter the trial will be confirmed for eligibility by an obstetrician. Prior to patients undertaking any trial-related procedures, informed consent will be obtained.
Participants will then be randomised in a 1:1 ratio to either 1) synthetic osmotic cervical dilator or 2) a 10-mg controlled-release dinoprostone vaginal insert. Randomisation will be provided by a computer generated programme. A research assistant discloses the nature of the assignment only after enrolment. Investigators have calculated that 860 patients (430 in each arm) will need to be recruited over a 2 year period. Given the nature of the intervention, the SOLVE trial will not be a blinded trial.
Full data collection will be conducted for those patients giving informed consent, from medical records. This will include baseline data, and details of mother and child at birth. Patients will also be asked to complete a maternal satisfaction questionnaire before they are discharged. There will be no further follow-up of patients post-discharge from care unless a Serious Adverse Event requires this. If the patient withdraws her consent during the study, data collection will be stopped. Only anonymised data will be entered into the Case Report Forms (CRFs) by the study team. Details of all patients approached about the trial will be recorded on the trial Screening Log, and fully anonymised copies returned to the trials office for review.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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West Midlands
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Birmingham, West Midlands, United Kingdom, B15 2TG
- Birmingham Women's and Children's NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
Women must meet the following criteria prior to initiation of IoL:
- ≥ 16 years of age
- Able to provide informed consent
- Singleton pregnancy
- Indication for IoL
- Pregnancy ≥ 37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan)
- Living fetus with vertex presentation
- Intact membranes
Exclusion criteria
- Women already receiving oxytocin
- Diagnosis of fulminant preeclampsia / eclampsia
- Contraindication to DINOPROSTONE or DILAPAN
- If DINOPROSTONE for IoL is non-compliant with local policy
- Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Propess
Control intervention: Propess® (dinoprostone) Slow release vaginal drug delivery system (Prostaglandin E2).
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Dinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman.
Other Names:
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Experimental: Dilapan-S
Experimental intervention: DILAPAN-S® A synthetic osmotic cervical dilator for insertion into the cervical canal, using as many rods as necessary.
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DILAPAN-S® is a non-pharmacological synthetic rod, which is inserted into the cervical canal and through the internal os, for cervical ripening prior to induction.
Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of DILAPAN-S® sticks, usually within a 12-hour period.
Subsequently it exerts radial pressure on the surrounding structures (cervix) to dilate progressively.
Endocervical pressure on the cervix results not only in its mechanical dilatation but the pressure on the endocervical structures also stimulates the production of endogenous PGs and promotes cervical ripening through its collagenolytic action.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure to achieve vaginal delivery
Time Frame: 1 year from study completion
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To evaluate the efficacy of the use of the synthetic osmotic cervical dilator in cervical ripening, prior to induction of labour, in comparison to dinoprostone vaginal insert in the parameter of failure to achieve vaginal delivery
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1 year from study completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
Time Frame: 24, 36 and 48 hours
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Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
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24, 36 and 48 hours
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caesarean section
Time Frame: 24 and 64 hours
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caesarean section undertaken between randomisation and delivery of fetus.
The maximum time period for use of trial induction methods is 64 hours for Propess and 24 for Dilapan-S, thus C-section should typically have taken place by these time periods.
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24 and 64 hours
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instrumental delivery
Time Frame: 24 and 64 hours
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instrumental delivery undertaken between randomisation and delivery of fetus.
The maximum time period for use of trial induction methods is 64 hours for Propess and 24 for Dilapan-S, thus instrumental delivery should typically have taken place by these time periods.
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24 and 64 hours
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spontaneous delivery
Time Frame: 0 - 64 hours
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spontaneous delivery between randomisation and delivery of fetus.
The maximum time period for use of intervention is 64 hours, so spontaneous labour should have taken place by this stage.
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0 - 64 hours
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Change in Bishop Score
Time Frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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change in Bishop Score compared at initiation of cervical ripening (i.e.
randomisation) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
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0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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Total duration of intervention received
Time Frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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Total duration of intervention received (i.e.
randomisation) and completion of cervical ripening (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
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0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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Use of Oxytocin
Time Frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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Use of Oxytocin for induction and/or augmentation of labour from randomisation to completion of induction (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
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0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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Use of Analgesia
Time Frame: 0 - 64 hours approx.
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Use of Analgesia during induction and/or labour (from randomisation until delivery of fetus).
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0 - 64 hours approx.
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Amniotomy undertaken
Time Frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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Amniotomy undertaken for induction and/or augmentation of labour from randomisation to completion of induction (i.e. when treatment is completed at 12 or 24 hours with Dilapan-S, or at 24, 32, 56 or 64 hours with Propess; or once labour is initiated - whichever comes first)
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0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.
Time Frame: 0 hours up to discharge (typically 4 days for c-section) or resolution of SAE (approx 2 weeks).
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maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.
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0 hours up to discharge (typically 4 days for c-section) or resolution of SAE (approx 2 weeks).
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maternal satisfaction with cervical ripening
Time Frame: 1hr to 4 days
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maternal satisfaction with cervical ripening collected after delivery, prior to discharge.
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1hr to 4 days
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fetal status after delivery
Time Frame: recorded on delivery of fetus
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fetal status after delivery recorded on delivery of fetus
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recorded on delivery of fetus
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Collaborators and Investigators
Investigators
- Principal Investigator: Janesh Gupta, MD, Birmingham Women's and Children's Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOLVE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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