An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt

Induction of Labor Affected Fetus / Newborn Clinical Trial

— SOLVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001661
• Other study ID #: Solve
• Status: Completed
• Phase: Phase 3
• Start date: December 19, 2017
• Est. completion date: February 6, 2021

Study information

• Verified date: July 2021
• Source: Birmingham Women's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 674
• Est. completion date: February 6, 2021
• Est. primary completion date: February 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion criteria

Women must meet the following criteria prior to initiation of IoL:

1. = 16 years of age

2. Able to provide informed consent

3. Singleton pregnancy

4. Indication for IoL

5. Pregnancy = 37.0 weeks (assessed as an agreed gestational age by ultrasound dating scan)

6. Living fetus with vertex presentation

7. Intact membranes Exclusion criteria

1. Women already receiving oxytocin

2. Diagnosis of fulminant preeclampsia / eclampsia

3. Contraindication to DINOPROSTONE or DILAPAN

4. If DINOPROSTONE for IoL is non-compliant with local policy

5. Enrolled in other randomised controlled trials of an IMP or device for cervical ripening or induction of labour

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Device:
• Dilapan-S
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.

Drug:
• Dinoprostone
Dinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman.

Locations

Country	Name	City	State
United Kingdom	Birmingham Women's and Children's NHS Trust	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
Birmingham Women's NHS Foundation Trust	Medicem International CR s.r.o., University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year from study completion
Secondary	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	24, 36 and 48 hours
Secondary	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.	24 and 64 hours
Secondary	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.	24 and 64 hours
Secondary	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.	0 - 64 hours
Secondary	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)	0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Secondary	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)	0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Secondary	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)	0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Secondary	Use of Analgesia	Use of Analgesia during induction and/or labour (from randomisation until delivery of fetus).	0 - 64 hours approx.
Secondary	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)	0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.
Secondary	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.	0 hours up to discharge (typically 4 days for c-section) or resolution of SAE (approx 2 weeks).
Secondary	maternal satisfaction with cervical ripening	maternal satisfaction with cervical ripening collected after delivery, prior to discharge.	1hr to 4 days
Secondary	fetal status after delivery	fetal status after delivery recorded on delivery of fetus	recorded on delivery of fetus