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:
Participant gender:
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
Details
Lead Sponsor:
Birmingham Women's NHS Foundation Trust
Collaborators:
Medicem International CR s.r.o. University of Birmingham