NCT02098382

Dilapan-S Osmotic Dilator in Pre-induction of Labor

Prospective Collection of Data About the Use of the Dilapan-S Osmotic Dilator in Pre-induction of Labor in Women With/Without Caesarean Section in Their History

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Medicem International CR s.r.o. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

Detailed description

Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. 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 which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Conditions

• Uterine Cervical Incompetence

Interventions

Type	Name	Description
DEVICE	Dilapan-S	Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2014-10-01
• First posted: 2014-03-28
• Last updated: 2015-07-29

Locations

1 site across 1 country: Czechia