Induction of Labor Affected Fetus / NewbornPhase 3SOLVENCT03001661
An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt
A Phase 3 study testing Dilapan-S and Dinoprostone in people with Induction of Labor Affected Fetus / Newborn, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Induction of labour (where labour is started artificially) is traditionally carried out with a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is a mechanical device, known as an osmotic cervical dilator, which provides an alternative to drugs or surgery. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induction of Labor Affected Fetus / Newborn
- What is being tested?
- Dilapan-S and Dinoprostone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2017to 6 Feb 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Women's and Children's NHS Trust
Birmingham, West Midlands, B15 2TG
About this study
Official title: A Randomised Controlled Trial of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt: the SOLVE Trial
Induction of labour (where labour is started artificially) is traditionally carried out with a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is a mechanical device, known as an osmotic cervical dilator, which provides an alternative to drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the natural process of 'ripening' (or preparing) the cervix. This initial process is important before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions that, when too frequent, may cause the baby to become distressed. The project will compare cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a single pregnancy, who require induction of labour, and who are not considered high risk, will be invited to participate. Investigators hope to recruit 860 women from UK maternity units over 2 years. Participants will have an equal chance of being randomised to the drug, which is standard practice, or the cervical dilator. The speed in which labour commences, the mode of delivery and any side effects will be compared. Importantly, investigators shall also assess patient satisfaction and anxiety during the induction process, by asking participants to complete a short questionnaire about their experience before they go home after having their baby. If osmotic dilators are effective investigators expect NICE to consider them an option alongside other cervical ripening methods.
Read the 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.
- Being tested
- Dilapan-S, Dinoprostone
- Keywords
- Propess, Dilapan-S, Dinoprostone, Labour, Induction, Child birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilapan-SDevice
Also called Synthetic Osmotic Cervical Dilator
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.
DinoprostoneDrug
Also called Propess
Dinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman.
| Study group | Role | What they receive |
|---|---|---|
| Propess | Active comparator | Control intervention: Propess® (dinoprostone) Slow release vaginal drug delivery system (Prostaglandin E2). Receives: Drug: Dinoprostone |
| Dilapan-S | Experimental | Experimental intervention: DILAPAN-S® A synthetic osmotic cervical dilator for insertion into the cervical canal, using as many rods as necessary. Receives: Device: Dilapan-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure to achieve vaginal delivery
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
Measured: 1 year from study completion
Secondary outcomes (12)
Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
Measured: 24, 36 and 48 hours
caesarean section
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.
Measured: 24 and 64 hours
instrumental delivery
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.
Measured: 24 and 64 hours
spontaneous delivery
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.
Measured: 0 - 64 hours
Change in Bishop Score
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)
Measured: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Total duration of intervention received
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)
Measured: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Use of Oxytocin
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)
Measured: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Use of Analgesia
Use of Analgesia during induction and/or labour (from randomisation until delivery of fetus).
Measured: 0 - 64 hours approx.
Amniotomy undertaken
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)
Measured: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.
maternal and neonatal safety: SAEs recorded from randomisation up to discharge, and resolution of SAE.
Measured: 0 hours up to discharge (typically 4 days for c-section) or resolution of SAE (approx 2 weeks).
maternal satisfaction with cervical ripening
maternal satisfaction with cervical ripening collected after delivery, prior to discharge.
Measured: 1hr to 4 days
fetal status after delivery
fetal status after delivery recorded on delivery of fetus
Measured: recorded on delivery of fetus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start19 Dec 2017
- Primary completion6 Feb 2021
- Study completion6 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Induction of Labor Affected Fetus / NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Birmingham, Medicem International CR s.r.o.
- Responsible party
- Principal investigator, Professor Janesh Gupta, Birmingham Women's and Children's NHS Foundation Trust
- Investigators
- Janesh Gupta, MD, Principal investigator, Birmingham Women's and Children's Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001661
- Sponsor's protocol ID
- Solve
- Acronym
- SOLVE
- Status last verified
- Jul 2021
- First submitted
- 11 Nov 2016
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators will not be sharing individual patient data with other research studies
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt: the SOLVE Trial
- ClinicalTrials.gov ID
- NCT03001661
- Acronym / sponsor ID
- SOLVE / Solve
- Keywords
- Propess, Dilapan-S, Dinoprostone, Labour, Induction, Child birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Collaborators
- University of Birmingham, Medicem International CR s.r.o.
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Induction of labour (where labour is started artificially) is traditionally carried out with a range of different drugs or by surgery (rupturing the membranes or 'waters'). Dilapan-S is a mechanical device, known as an osmotic cervical dilator, which provides an alternative to drugs or surgery. Thin rods of an absorbent material (no active drug present) are inserted into the neck of the womb (cervix) and, as they absorb fluid, they swell and mimic the natural process of 'ripening' (or preparing) the cervix. This initial process is important before contractions begin. Unlike drugs, Dilapan-S does not cause premature contractions that, when too frequent, may cause the baby to become distressed. The project will compare cervical ripening using Dilapan-S with the standard use prostaglandin drug. Women with a single pregnancy, who require induction of labour, and who are not considered high risk, will be invited to participate. Investigators hope to recruit 860 women from UK maternity units over 2 years. Participants will have an equal chance of being randomised to the drug, which is standard practice, or the cervical dilator. The speed in which labour commences, the mode of delivery and any side effects will be compared. Importantly, investigators shall also assess patient satisfaction and anxiety during the induction process, by asking participants to complete a short questionnaire about their experience before they go home after having their baby. If osmotic dilators are effective investigators expect NICE to consider them an option alongside other cervical ripening methods.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propess | Active comparator | Drug: DinoprostoneControl intervention: Propess® (dinoprostone) Slow release vaginal drug delivery system (Prostaglandin E2). |
| Dilapan-S | Experimental | Device: Dilapan-SExperimental intervention: DILAPAN-S® A synthetic osmotic cervical dilator for insertion into the cervical canal, using as many rods as necessary. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dilapan-SAlso: Synthetic Osmotic Cervical DilatorDILAPAN-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. | Device | Dilapan-S |
| DinoprostoneAlso: PropessDinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman. | Drug | Propess |
Primary outcome
Failure to achieve vaginal delivery
Time frame: 1 year from study completion
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
12 secondary outcomes
Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation
Time frame: 24, 36 and 48 hours
caesarean section
Time frame: 24 and 64 hours
instrumental delivery
Time frame: 24 and 64 hours
spontaneous delivery
Time frame: 0 - 64 hours
Change in Bishop Score
Time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Total duration of intervention received
Time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Use of Oxytocin
Time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Use of Analgesia
Time frame: 0 - 64 hours approx.
Amniotomy undertaken
Time frame: 0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
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).
maternal satisfaction with cervical ripening
Time frame: 1hr to 4 days
fetal status after delivery
Time frame: recorded on delivery of fetus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: No. Investigators will not be sharing individual patient data with other research studies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janesh Gupta, MD principal investigator
Birmingham Women's and Children's Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dilapan-S and Dinoprostone in people with Induction of Labor Affected Fetus / Newborn, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure to achieve vaginal delivery (time frame: 1 year from study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03001661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.