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

• Status: Completed
• Trial end date: 2021-02-06
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Birmingham Women's NHS Foundation Trust
• Collaborators: Medicem International CR s.r.o.; University of Birmingham
• Treatments: Dinoprostone

Criteria

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