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

NCT03001661 | Completed Phase 3 DMC

• 1 other identifier: Solve
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

Propess; Dilapan-S; Dinoprostone; Labour; Induction; Child birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Failure to achieve vaginal delivery within 24, 36 and 48 hours from randomisation

  24, 36 and 48 hours

• caesarean section

  24 and 64 hours

• instrumental delivery

  24 and 64 hours

• spontaneous delivery

  0 - 64 hours

• Change in Bishop Score

  0 hours, 12 hours, 24 hours, 32 hours, 56 hours, 64 hours.

Study Arms (2)

Propess

ACTIVE COMPARATOR

Control intervention: Propess® (dinoprostone) Slow release vaginal drug delivery system (Prostaglandin E2).

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.

Device: Dilapan-S

Interventions

Dilapan-S DEVICE

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.

Also known as: Synthetic Osmotic Cervical Dilator

Dilapan-S

Dinoprostone DRUG

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

Also known as: Propess

Propess

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead
• University of Birmingham: collaborator
• Medicem International CR s.r.o.: collaborator

Study Sites (1)

Birmingham Women's and Children's NHS Trust

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36996264 DERIVED

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Janesh Gupta, MD

  Birmingham Women's and Children's Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: December 23, 2016
• Study Start: December 19, 2017
• Primary Completion: February 6, 2021
• Study Completion: February 6, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)