SOLVE
Research type
Research Study
Full title
Randomised controlled trial on the use of synthetic osmotic cervical dilator in induction of labour in comparison to dinoprostone vaginal insert
IRAS ID
208770
Contact name
Janesh Gupta
Contact email
Eudract number
2016-004726-42
Duration of Study in the UK
3 years, 0 months, 1 days
Research 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. We 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 osmotic cervical dilator. The speed in which labour commences, the mode of delivery and any side effects will be compared. Importantly, we shall also assess patient satisfaction and anxiety during the induction process. We will ask participants to complete a short questionnaire about their experience before they go home after having their baby. If osmotic dilators are effective we expect NICE to consider them an option alongside other cervical ripening methods.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0011
Date of REC Opinion
15 Feb 2017
REC opinion
Further Information Favourable Opinion