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

PHASE3CompletedINTERVENTIONAL
Enrollment

674

Participants

Timeline

Start Date

December 19, 2017

Primary Completion Date

February 6, 2021

Study Completion Date

February 6, 2021

Conditions
Induction of Labor Affected Fetus / Newborn
Interventions
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.

Trial Locations (1)

B15 2TG

Birmingham Women's and Children's NHS Trust, Birmingham

Sponsors
All Listed Sponsors
collaborator

University of Birmingham

OTHER

collaborator

Medicem International CR s.r.o.

INDUSTRY

lead

Birmingham Women's NHS Foundation Trust

OTHER_GOV